BMJ Open€¦ · 19 Whilst Randomised Controlled Trials (RCTs) are regarded as the gold standard...
Transcript of BMJ Open€¦ · 19 Whilst Randomised Controlled Trials (RCTs) are regarded as the gold standard...
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Barriers and enablers to the delivery and impact of an incentive-based behaviour change strategy targeting child
obesity: Protocol for a process evaluation
Journal: BMJ Open
Manuscript ID bmjopen-2016-012536
Article Type: Protocol
Date Submitted by the Author: 05-May-2016
Complete List of Authors: Enright, Gemma; Cardiovascular Divsion Gyani, Alex; NSW Department of Premier and Cabinet, Behavioural Insights Unit
Raadsma, Simon; NSW Department of Premier and Cabinet, Behavioural Insights Unit Allman-Farinelli, Margaret; University of Sydney, Faculty of Science Rissel, Chris; Ministry of Health, NSW Office of Preventative Health, Innes-Hughes, Christine; Ministry of Health, NSW Office of Preventative Health, Lukeis, Sarah; The Better Health Company Rodgers, Anthony; The George Institute for Global Health, Sydney Medical School, University of Sydney, Redfern, Julie; The George Institute for Global Health, Sydney Medical School, University of Sydney, Cardiovascular Division
<b>Primary Subject
Heading</b>: Public health
Secondary Subject Heading: Qualitative research, Health policy
Keywords: Community child health < PAEDIATRICS, PUBLIC HEALTH, QUALITATIVE RESEARCH
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Barriers and enablers to the delivery and impact of an incentive-based 1
behaviour change strategy targeting child obesity: Protocol for a process 2
evaluation 3
4
Gemma Enright1, 2, Alex Gyani2, Simon Raadsma2, Margaret Allman-Farinelli3, Chris 5
Rissel4, Christine Innes-Hughes4, Sarah Lukeis5, Anthony Rodgers1, Julie Redfern1 6
7
1 The George Institute for Global Health (Cardiovascular Division), Sydney Medical 8
School, University of Sydney, Australia 9
2 NSW Department of Premier and Cabinet, Behavioural Insights Unit, Sydney, 10
Australia 11
3 Charles Perkins Centre, University of Sydney, Australia 12
4 Ministry of Health, NSW Office of Preventative Health, Sydney, Australia 13
5 The Better Health Company, Melbourne, Australia 14
15
Corresponding author 16
Gemma Enright 17
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown, NSW 18
Australia, 2050 19
T +61 2 8052 4505 20
E [email protected] 21
22
ABSTRACT 23
Introduction: Community-based weight management programs are important in 24
addressing childhood obesity. However, the mechanisms that lead to behaviour 25
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change within the programs are rarely studied within the context of the programs 1
themselves once they have been implemented. This means that further potential 2
gains in the effectiveness of the program are often not made and any potential 3
losses of efficacy are often not noticed. Qualitative research alongside randomised 4
controlled trials (RCTs) can tell us the context in which these programs are 5
implemented and elucidate potential mediators or modifiers of the programs’ 6
effectiveness. The aim of this evaluation is to evaluate the barriers and enablers to 7
the delivery and impact of an incentive-based behaviour change strategy targeting 8
child obesity to inform future translation. 9
Methods and analysis: Mixed methods qualitative analysis including stakeholder 10
and family interviews, focus groups and a survey will be used. The research will be 11
conducted in collaboration with policy makers, researchers, and community health 12
professionals. Participants will be selected from program providers, and parents/ 13
carers and children participating in an Australian community weight management 14
program during an RCT examining the effectiveness of incentives for improving 15
behaviour change. A maximum variation sampling method based on participant 16
demographics and group characteristics will be used. Thematic analysis will be 17
carried out inductively based on emergent themes, using NVivo 9. 18
Ethics and dissemination: 19
This research is approved by the South West Sydney Human Ethics Committee 20
review body (HREC/14/LPOOL/480). The evaluation will provide information about 21
the contextual and influencing factors related to the outcomes of the RCT. The 22
results will assist researchers, community health practitioners and policy makers 23
regarding the development, implementation and translation of behaviour change 24
strategies in community initiatives for obese children. Insights gained may be 25
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applicable to a range of chronic conditions where similar preventative intervention 1
approaches are indicated. 2
3
STRENGTHS AND LIMITATIONS OF THIS STUDY 4
Strengths 5
• A mixed methods qualitative design enables the collection of detailed 6
perspectives from many stakeholders and many participating families. 7
• Analyses will be grounded in the data, enabling new theories explaining 8
behaviour change related to incentives and goal setting to emerge. 9
• The evaluation design allows for comparisons between the intervention and 10
control group between sites, which will facilitate conclusions related to the 11
generalisability of the findings. 12
• Conducting the evaluation immediately after the follow-up health assessments 13
of the RCT allows for data collection whilst the program is still fresh in 14
participants’ minds, whilst minimising contamination to the RCT itself. 15
16
Limitations 17
• There will be no opportunity in this design to carry out structured observations 18
of the intervention during the implementation phase itself. Data will be 19
collected in retrospect. 20
21
KEYWORDS 22
Childhood obesity, public health, incentives, behaviour change, qualitative 23
24
BACKGROUND 25
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Childhood obesity is a global priority that many countries are currently trying to 1
address. In 2013 the number of overweight children under the age of five was 2
estimated to be over 42 million.[1] Overweight and obese children are likely to stay 3
obese into adulthood [2] and are more likely to develop chronic diseases like 4
diabetes and cardiovascular diseases at a younger age.[3] The increasing 5
prevalence also has implications for current and future health service.[4] Therefore 6
improving the management of childhood obesity is extremely important, alongside 7
preventive measures. Community-based weight-management programs are an 8
important response to address childhood obesity, however child-focused obesity 9
services are limited and there is scope for optimising attendance and outcomes, and 10
for translation into the broader context.[5] Although, the specific behaviours required 11
for effective weight-loss are well established,[6 - 11] associated implementation 12
challenges mean they are often not up-scaled and translated into a natural 13
context.[5, 9, 12] 14
15
Difficulties associated with facilitating health-related behaviour change has led to an 16
increased emergence of research investigating whether incentive schemes (based 17
on psychological and behavioural theory and research) might be a potential solution. 18
As such, promising research in adults has found that incentives can positively 19
influence health-related behaviour change in the short term.[13 - 15] For example, 20
several systematic reviews have demonstrated positive outcomes as a result of 21
financial incentives in terms of healthy eating,[16 - 18] and positive effects on 22
exercise behaviour.[19, 20] However, robust research investigating the value of 23
incentives focused on improving health-related behaviours in children is still limited. 24
25
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Several studies have highlighted the potential value of behavioural incentives in 1
children. One non-randomised study (n=1589) has demonstrated that an incentive-2
program, based on lottery-style tickets, increased the probability of children bike 3
riding to school by 16%.[21] Three randomised studies (across 40 elementary 4
schools) have reported that small rewards (such as stickers or low value financial 5
rewards) doubled the number of children consuming a serving of fruit or vegetables 6
with their school lunch,[22 - 24] and two of these studies found evidence of sustained 7
effects at two months [23] and six months [24] after the intervention. However, these 8
studies are based on small samples, the duration of the intervention and follow-up 9
tends to be short and inconsistent between studies (e.g. intervention duration ranged 10
from two to five weeks, and follow-up duration ranged from four weeks to six 11
months), they investigate a single health-related behaviour (i.e. either diet or 12
exercise) and there is no known qualitative research associated with the trials. There 13
is also no systematic review of good quality trials focusing on incentives and health-14
related behaviours in children and therefore, robustly designed research is needed to 15
provide more information on for whom and in what context incentive schemes might 16
be most effective. 17
18
Whilst Randomised Controlled Trials (RCTs) are regarded as the gold standard for 19
establishing the effectiveness of interventions, RCTs are incompatible with 20
understanding how complex interventions work in context.[25] Effect sizes alone do 21
not provide policy makers with information on how an intervention might be 22
replicated in their specific context, whether intervention outcomes will be reproduced, 23
or the broader impact on participants’ lives.[26] Conducting a process evaluation 24
alongside a RCT provides a deep understanding of how interventions are 25
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implemented, what worked and didn’t work, and in which contexts it was most and 1
least effective and why.[27] In particular, qualitative research is extremely valuable 2
for understanding the more subjective nature of participants’ experiences and 3
determining what kind of change has occurred.[26, 28] Therefore, completion of a 4
detailed qualitative process evaluation will facilitate the translation of knowledge from 5
clinical research with children, and help guide how effective incentive strategies 6
could be optimally implemented into routine practice for addressing childhood 7
obesity. Furthermore, using knowledge translation frameworks within the process 8
evaluation will enable us to identify active components of the intervention that 9
change behaviour, causal mechanisms of change, effective modes of delivery, and 10
the intended population.[29] This will facilitate integration of the interventions into 11
community health settings, and policy. 12
13
In summary, managing childhood obesity is a global priority, and there is a gap in the 14
evidence base on the impact of incentives on health behaviours in children, and 15
qualitative research identifying contextual factors associated with variation in 16
intervention delivery and outcomes. The aim of this study is to qualitatively evaluate 17
the barriers and enablers to delivery, mechanisms of impact, and the broader 18
impacts of an incentive-based behaviour change intervention to improve sustained 19
behaviour change in overweight and obese children, to build the evidence base and 20
inform policy and practice. Specific aims of this research are to: 21
1. Determine the degree to which the goals and rewards intervention was 22
implemented as intended (process evaluation). 23
2. Understand the contextual factors influencing intervention outcomes and the 24
broader impact on participants’ lives (impact evaluation). 25
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3. Identify the mechanisms of impact through which the various components of 1
the intervention were effective (evaluation of behavioural concepts 2
underpinning the intervention). 3
4
MEHODS/ DESIGN 5
Setting 6
The evaluation will be conducted at the six and 12-month data collection points of a 7
RCT conducted in New South Wales (NSW) Australia. The details of the RCT design 8
are described elsewhere.[30] In summary, the intervention (n=524 children and 38 9
community-based program sites across five Local Health Districts (LHDs)) is a 10
cluster RCT testing the use of incentives linked to goal setting for sustained 11
behaviour change in overweight and obese children aged 7-13. The RCT is set 12
within the context of an existing Australian community-based weight management 13
program. 14
15
The weight management program, ‘Go4Fun’, is a free, voluntary program run by 16
health professionals, addressing weight-related behaviour and self-esteem for 17
overweight or obese children aged 7-13 years. Go4Fun is based on the Mind 18
Exercise Nutrition Do-it (MEND) child weight management program in the UK, which 19
has demonstrated efficacy in weight outcomes (reduced waist and body mass index 20
(BMI) measures, and improvements in physical activity and self-esteem).[31] The 21
program is multidisciplinary and evidence-based, and incorporates elements 22
recognised as important to achieve long-term behaviour changes, such as family 23
involvement, practical education in nutrition and diet, and increasing physical 24
activity.[8, 9] Control sites in the trial delivered the standard weight management 25
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program content consisting of weekly two-hour group sessions for 10 weeks during 1
the school term. Intervention sites delivered the standard program together with an 2
enhanced goal setting and structured incentive scheme for goal achievement. This 3
was supported in the six months following the program by weekly text messages and 4
a lucky-draw style incentive. 5
6
How the outcomes in the RCT relate to this evaluation 7
The RCT is measured by the following outcomes: 8
• Primary outcomes: BMI and waist circumference at end of the community 9
weight management program (10 weeks) 10
• Secondary outcomes: nutrition and physical activity behaviours, and self-11
esteem at end of program (10 weeks) 12
• Attendance rates: Completion of >75% of sessions 13
• Achievement of physical activity and nutrition goals during the program 14
• Sustained health outcomes: primary and secondary health outcomes at six 15
and 12 months after the program 16
These outcomes will serve as focus points in this evaluation, which aims to provide 17
the context for better understanding variation in RCT outcomes. 18
19
Participants 20
The participants in this evaluation will come from these two groups: 21
First, existing participants in the RCT (parents/ carers and their children), who have 22
consented to being invited to further research. These will be recruited for the 23
evaluation via a brief survey given to parents/ carers during the six-month health 24
assessments in the RCT. All children participating in the RCT are aged 7-13 years, 25
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have a BMI greater than the 85th percentile for their age and gender (according to 1
the Centre for Disease Control classification of overweight/ obesity in children,[32]) 2
were enrolled in and met the criteria to participate in the community weight 3
management program at one of the sites participating in the study. Families self-4
referred via a toll-free phone number, text message or online registration to the 5
program, and secondary referrals were accepted from health professionals, 6
organisations and community members. Eligibility was assessed at the time of 7
referral or contact with LHDs and based on anthropometric measures and a medical 8
questionnaire completed by a parent/ carer, who also provided written consent for 9
their child to participate in the research. A maximum variation sampling method 10
based on the community weight management program participant demographics and 11
program group characteristics will be used. In the sample of parents/ carers and 12
children we will aim to include; high and low attendance (</>50%) in the weight 13
management program, single child and multiple sibling families, participants from 14
smaller program groups (<six children) and larger program groups (>eight children). 15
A variation of ethnicity, culturally and linguistically diverse (CALD) and 16
socioeconomic status (SES) characteristics will also be included. 17
Second, participants in the evaluation shall be stakeholders involved in the delivery 18
of the RCT, including; public servants, policy makers, behavioural specialists, 19
program managers for Local Health Districts, and community health professionals 20
(see Table 3). These shall be selected, beginning with core stakeholders directly 21
involved in the design and implementation of the RCT, and informed by the research 22
data collection as it progresses. 23
24
Design 25
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Logic model 1
The logic model (Figure 1) shows the aspects most critical to the success of the 2
RCT, to guide this evaluation. The logic model shows the intended inputs and 3
activities involved in implementing the intervention as well as the intended outcomes 4
and broader impacts. 5
6
Levels of evaluation and how they relate to the Logic model 7
Three levels of evaluation will be conducted: (1) process, (2) impact, and (3) 8
theoretical analysis. The evaluation plan is summarised in Table 1. 9
10
Table 1. Evaluation plan 11
Aim
Levels of evaluation and how they relate to Logic model
Evaluation component
Data source
Timing of data collection
1. Determine the degree the goals and rewards intervention was implemented as intended by the trial Working Group
Level: Process evaluation. Relates to intended activities and outputs in the logic model
Content delivery Engagement Reach
A combination of: Focus groups with parents/ carers Family interviews Stakeholder interviews Survey of parents/ carers
One month after the six month health assessments as part of the RCT The survey will be administered during participation in the six month health assessments
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2. Understand the contextual factors influencing intervention outcomes and the broader impact on participants’ lives
Level: Impact evaluation. Relates to intended outcomes and impacts in the logic model
The broader environment Key participant characteristics Program factors
Family interviews
One month after the twelve month health assessments as part of the RCT
3. Identify the mechanisms of impact through which the various components of the intervention were effective
Evaluation of behavioural concepts
Evaluation of causal assumptions underpinning interventions
Discourse analysis
On completion of objectives 1 and 2
1
Aim 1. Process evaluation 2
To determine the degree the intervention was implemented as intended the 3
evaluation will aim to document how the intervention was delivered and received 4
from the perspectives of those delivering and receiving the intervention, and 5
compare this with intended implementation by the trial Stakeholder Working Group 6
(see Acknowledgements). 7
8
The Normalisation Process Theory model (NPT) [33] was used to guide the design 9
of the process evaluation. NPT provides a conceptual framework for understanding 10
the processes by which interventions are implemented and integrated into everyday 11
practice. The model explores factors involved in the dynamics between people 12
delivering and receiving the intervention in order to account for outcomes of the 13
implementation process, and differences between expected and observed outcomes 14
in real settings. In implementing an intervention in a real setting NPT argues that 15
people need to continuously make sense of the work they are doing (coherence), 16
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engage with it (cognitive participation), enact it (collective action), and reflect on it 1
(reflective monitoring). With an emphasis on exploring these concepts the process 2
evaluation will look at three components. These are: content delivery, engagement, 3
and reach, and are shown in Table 1. Content delivery refers to the delivery of each 4
individual input component of the intervention. Engagement will explore the variation 5
in the goal achievement outcome measure for the intervention. Reach refers to the 6
proportion of the intended target audience who participated in the intervention. The 7
process evaluation will explore reasons expressed for discontinuing the program. 8
9
Aim 2. Impact evaluation 10
The Realistic Evaluation model [34] will be used to inform the investigation of 11
contextual factors that affect the trial outcomes. To ascertain which contextual 12
factors played a role in trial outcomes the impact evaluation will identify the 13
environmental and social factors associated with participation in the intervention, as 14
well as individual attitudes and beliefs about healthy living and associated barriers 15
and enablers to adapting to new behaviours and forming new habits. 16
17
Table 1 outlines the three key components the investigation will focus on. These are: 18
the broader environment, participant characteristics, and program factors. The 19
broader environment refers to other health activity, particularly other interventions 20
and healthy eating programs the family was involved in at the time of the 21
intervention, as well as barriers and enablers to participation and engagement in the 22
community weight management program associated with the home environment and 23
the families’ lifestyle. Participant characteristics were identified at baseline in the trial 24
and include; age, gender, single or separated family status, single or multiple sibling 25
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family. Program factors to be explored include; size of the community weight 1
management program group, regional or metro site location, venue type, and day the 2
program sessions were held (weekday or a weekend day), and will also be informed 3
by the process evaluation. 4
5
The impact evaluation will focus on primary and secondary intended behavioural 6
changes (reduced BMI, waist circumference, nutrition, physical activity and self-7
esteem), and other intended outcomes (increased program attendance rates and 8
improved goal achievement during the program). The impact evaluation will identify 9
for whom the incentive program was most and least effective in terms of having a 10
sustained positive impact on participants’ lives 12 months after the community 11
weight management program, and will assess the strength of the evidence for 12
informing translation into policy and future program delivery. 13
14
Aim 3. Evaluation of behavioural concepts 15
The design of the intervention draws upon behavioural literature on the impact of 16
incentives on health-related behaviour, and this evaluation will focus on which 17
components of the intervention participants and stakeholders felt were most 18
effective. 19
20
The intervention was developed iteratively in 2014 using a review of the relevant 21
literature, workshops, focus groups and field visits. The review of the literature and 22
program staff advice highlighted the importance of incentivising behaviour (e.g. 23
exercise, healthier lunches, less snacking etc.) rather than outcomes (e.g. weight 24
loss)[35, 36] for longer-term positive outcomes. The community program leaders 25
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also indicated during field research that while goal setting as part of the program was 1
usually specific, measureable, achievable, relevant, and timely (SMART), it was 2
likely to be of value to enhance the goal setting process, including resetting/ 3
stretching goals if they are achieved too easily, as linking goal achievement to 4
incentives. Table 2 summarises the key concepts that informed the behavioural 5
interventions. The presence of behaviours relating to these concepts will be 6
thoroughly explored in this research. 7
8
Table 2. Key behavioural concepts used and corresponding interventions developed 9
in the RCT 10
*Corresponds with Inputs (Material resources) and Activities in the Logic model 11
Behavioural concept Intervention* Reference Incentivising behaviour rather than outcomes has potential for a sustained impact Reward linked to goal attainment has a more positive longer term effect than rewarding outcomes
• Enhanced goal setting process including re-setting and stretching goals (with modified SMART goals handout)
• Rewards scheme linked to weekly nutrition and exercise goal attainment
• Fryer (2011)[35] • Gneezy et al
(2011)[37] • Anderson et al
(2011)[38]
People are motivated to complete a goal when they can see their progress Small and frequent rewards can increase task perseverance
• Group Goals and Rewards Tracker
• Low value weekly rewards
• Kivetz et al (2006)[39]
An implementation intention can help people achieve a goal
• Modified Goals and Rewards Contract (between parent/ carer and child)
• Adriaanse et al (2011)[40]
• Gollwitzer & Sheeran (2006)[41]
• Bellanger-Gavel et al (2013)[42]
Lucky draw-style rewards may be an effective mechanism for up-scaling
• Prize draw incentive at six months post community weight management
• Giles et al (2014)[43] • Strohacker et al
(2013)[19]
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program • Cuffe et al (2012)[21] Text message prompts can improve health behaviours
• SMS scheme linked to six month prize draw
• Hallsworth et al (2015)[44]
1
Data Sources 2
The evaluation will use a mixed methods qualitative analysis, which will explore 3
multiple groups of people’s perspectives on the benefits, acceptability, and other 4
ways in which incentives could be used for behaviour change. Data collection will 5
include a combination of focus groups, family and stakeholder interviews, and a 6
survey. Table 3 provides details of the data sources and their aims. 7
8
Table 3. Summary of data sources and their aims 9
Data source Scope Recruited by Aim 1.Survey of parents/ carers who participated in the community program
A 5-minute written survey of 10 questions with a mix of open-ended, single and multiple response questions. One per parent/ carer (control and treatment)
Distributed and collected at the six month health assessments
Obtain top of mind feedback on core elements of the intervention, and invite families to consent to be contacted for a focus group or family interview
2. Focus groups with parents/ carers
4-6 groups, lasting 30-60mins, with 6-8 participants depending on thematic saturation
Brief survey. Selection will be based on quota specifications around key participant and group characteristics (see ‘Participants’)
Explore experiences, perceptions and engagement in the specific intervention components
3. Family interviews with parents/ carers and their children who participated in the community program, and other family members
10-20 interviews lasting 30-60mins, depending on thematic saturation
Brief survey. Selection will be based on quota specifications around key participant and group characteristics (see
Gain insights into the impacts of the intervention in the context of the unique characteristics of the family’s lifestyle.
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(e.g. siblings) ‘Participants’)
4. Stakeholder interviews
10 individual or group interviews depending on thematic saturation
Phone calls made by GE. Stakeholders will be targeted according to quotas based on roles in the various design and implementation stages of the RCT
Understand issues specifically around the intended and actual delivery of the intervention
1
Discussions in the focus groups and interviews will follow standard methodology [45] 2
and will be recorded and transcribed verbatim. Participants will be made aware of 3
this at the start of the group or interview and their consent obtained. All discussions 4
will be confidential. GE will conduct the focus groups and interviews in a private room 5
within a facility near to the participants’ residence (such as a community centre) or 6
place of work. A second researcher will also be present in the room in an 7
observatory capacity to take notes during the group discussion. Refreshments and 8
parking reimbursement will be provided for focus group participants. To optimise 9
attendance, a $40 (e.g. a supermarket voucher) will be offered to each family who 10
participates in an interview. 11
12
Data analysis and synthesis 13
Data analysis and synthesis will be based on the Grounded Theory approach.[46 - 14
48] The outcome will be a set of probability statements about the relationship 15
between concepts, or a set of conceptual hypotheses [47]. The analysis will identify 16
the factors that participants felt led to behaviour change, and the behaviours that 17
informed the interventions (highlighted in Table 2 above) will be investigated. The 18
mechanisms of the incentives-based behaviour change strategy that lead to 19
behaviour change and habit formation may be influenced by factors outside of those 20
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identified in the previous literature. The researchers will also explore other 1
mechanisms that might have an impact. 2
3
Qualitative data from focus groups, family and stakeholder interviews, and the 4
survey will be transcribed and systematically coded, drawing out the key points. 5
Similar codes will be grouped into concepts and categories based on emergent 6
themes. The coding process will begin with the first interview and be repeated for 7
each subsequent interview or focus group with the use of field notes, memos and 8
constant comparison to accumulate ideas about how concepts relate to each other. 9
For each transcript examples will be extracted that either confirm or contradict the 10
emerging themes. Once thematic saturation occurs, no further interviews and focus 11
groups will which will be necessary. 12
Two researchers will conduct the analysis, and if at any stage consensus cannot be 13
reached, a third researcher will review those aspects. NVivo software will be used to 14
assist with qualitative data management. 15
16
Timing of data collection 17
The timing of the data collection is shown in Table 1. Data will be collected at two 18
points: (1) one month after the six-month health assessments in the trial, where the 19
process evaluation shall be undertaken; and (2) one month after the twelve-month 20
health assessment, when the impact evaluation shall be undertaken. Conducting the 21
fieldwork close to the follow-up assessments will minimise corruption of the 22
concurrent trial as the evaluation fieldwork will prompt people to remember their 23
experiences during a pre-scheduled intervention point. Research will commence in 24
late June 2016. 25
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1
DISCUSSION 2
This paper details a qualitative mixed methods evaluation to be conducted alongside 3
a RCT aimed at increasing behaviour change in overweight and obese children 4
participating in a community-based obesity program. The evaluation aims to 5
investigate the challenges of public health interventions and provide information 6
about the contextual factors related influencing the effect of the behaviour change 7
interventions. This will aid the interpretation of the RCT, which will focus on the 8
quantitative impact of the intervention. 9
10
Process evaluations can considerably add value to the interpretation of outcomes of 11
the incentives-based RCT,[26] to inform future implementation and translation as a 12
behaviour change strategy for managing obesity in overweight children, should the 13
interventions be effective. 14
15
This evaluation will explore the relationships between intervention delivery, 16
contextual factors influencing outcomes, and the mechanisms of impact. The results 17
will assist researchers, community health practitioners and policy makers in 18
implementing behaviour change strategies in community initiatives for overweight 19
and obese children and their families. The knowledge will also aid the development 20
of further strategies for health-related behavior change in children, supporting 21
positive change in tackling the growing global problem of obesity. 22
23
DECLARATIONS 24
Ethics approval and consent to participate 25
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The study has been approved by the South West Sydney Human Ethics Committee 1
review body (HREC/14/LPOOL/480). Appropriate site-specific approvals have been 2
obtained from relevant research governance offices. Consent was obtained from 3
existing RCT participants during the trial to be contacted for qualitative research. 4
5
Competing interests 6
None known 7
8
Authors’ contributions 9
GE led the drafting of all sections of the article in consultation with all the co-authors. 10
JR/ GE led the application for funding for this work. All authors provided substantial 11
contribution to the concept and design of the evaluation, drafting the protocol paper 12
and reviewing critically for important intellectual content and final approval of the 13
version for publication. 14
15
Funding 16
This research is funded in-kind provided by the George Institute for Global Health 17
and the Department for Premier and Cabinet. GE is funded by a PhD scholarship 18
through the George Institute for Global Health within the NHMRC program grant 19
ID1052555. JR is funded by a Career Development and Future Leader Fellowship 20
co-funded by the National Health and Medical Research Council and the National 21
Heart Foundation. AR is funded by an NHMRC Principal Research Fellowship 22
APP1124780. JR and AR are investigators on NHMRC program grant ID1052555. 23
24
Acknowledgements 25
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This evaluation would not have been possible without the contributions of the RCT 1
investigator team and Working Group. Investigators and Working Group members 2
who are not co-authors on this paper, and their affiliates are listed below: 3
• Office of Preventative Health: Anita Cowlishaw; Santosh Kanal; Nicholas 4
Petrunoff 5
• Behavioural Insights Unit, Department of Premier and Cabinet: Shirley Dang 6
• Western Sydney LHD: Christine Newman; Michelle Nolan; Deborah Benson, 7
Kirsti Cunningham 8
• South Western Sydney LHD: Mandy Williams; Leah Choi; Kate Jesus; 9
Stephanie Baker 10
• South Eastern Sydney LHD: Myna Hua; Linda Trotter; Lisa Franco 11
• North Sydney LHD: Paul Klarenaar; Jonothan Noyes; Sakara Branson 12
• Hunter New England LHD: Karen Gillham; Dr John Wiggers; Silvia Ruano-13
McLerie 14
• Mid North Coast LHD: Ros Tockley; Margo Johnson 15
• Better Health Company; Madeline Freeman; Bec Thorp 16
• The George Institute for Global Health; Sarah Eriksson; Caroline Wu 17
In addition we thank the Go4Fun program leaders, and representatives from our 18
funding partner organisations, including the Heart Foundation, who have contributed 19
to the development and implementation of the RCT. 20
21
REFERENCES 22
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Inputs
Resources available for
the intervention
Stakeholder resources • Collaboration on trial
design, incentive
selection and
implementation • Randomisation • Recruitment of LHDs
and participants • Training: webinar
training for Go4Fun
leaders • Site visits (ensuring
fidelity)
Material resources • Group attendance and
Goals and Rewards tracker
• Goals and Rewards
Contract • SMART handout • SMS protocol
Activities
Adaptation to standard
Go4Fun program
During 10-week program Support of parents and
children to: • Identify healthy
aspirations • Set SMART and
stretching goals • Link goals and
incentives
Post 10-week program • Identify on-going goals
for six-months • Sustain engagement
through weekly SMS • Link goals and
incentives
Outcomes
Products of activities,
measured objectively
Health outcomes • Primary health
measure: BMI and
waist circumference (z
scores) at end of the
program (10 weeks) • Secondary health
outcomes: Nutrition and
physical activity
behaviours (self
reported by parent/
carer), self-esteem (self
reported by child) at
end of program (10
weeks) • Sustained health
outcomes: Primary and
secondary health
outcomes at six and 12
months after the
program
Other outcomes • Increased attendance
rates: Completion of
>75% of sessions • Improved achievement
of physical activity and
nutrition goals during
the program
Impacts
Fundamental change
occurring as a result of the
intervention • Positive impact on
health behaviours at 12
months • Translation into wider
policy
Intended results Planned work
Figure 1. Behavioural incentives intervention logic model
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Evaluating factors influencing the delivery and outcomes of an incentive-based behaviour change strategy targeting
child obesity: Protocol for a qualitative process and impact evaluation
Journal: BMJ Open
Manuscript ID bmjopen-2016-012536.R1
Article Type: Protocol
Date Submitted by the Author: 03-Aug-2016
Complete List of Authors: Enright, Gemma; Cardiovascular Divsion Gyani, Alex; NSW Department of Premier and Cabinet, Behavioural Insights Unit Raadsma, Simon; NSW Department of Premier and Cabinet, Behavioural Insights Unit Allman-Farinelli, Margaret; University of Sydney, Faculty of Science Rissel, Chris; Ministry of Health, NSW Office of Preventative Health, Innes-Hughes, Christine; Ministry of Health, NSW Office of Preventative Health, Lukeis, Sarah; The Better Health Company
Rodgers, Anthony; The George Institute for Global Health, Sydney Medical School, University of Sydney, Redfern, Julie; The George Institute for Global Health, Sydney Medical School, University of Sydney, Cardiovascular Division
<b>Primary Subject Heading</b>:
Public health
Secondary Subject Heading: Qualitative research, Health policy
Keywords: Community child health < PAEDIATRICS, PUBLIC HEALTH, QUALITATIVE RESEARCH
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1
Evaluating factors influencing the delivery and outcomes of an incentive-1
based behaviour change strategy targeting child obesity: Protocol for a 2
qualitative process and impact evaluation 3
Gemma Enright1, 2, Alex Gyani2, Simon Raadsma2, Margaret Allman-Farinelli3, Chris 4
Rissel4, Christine Innes-Hughes4, Sarah Lukeis5, Anthony Rodgers1, Julie Redfern1 5
6
1 The George Institute for Global Health (Cardiovascular Division), Sydney Medical 7
School, University of Sydney, Australia 8
2 NSW Department of Premier and Cabinet, Behavioural Insights Unit, Sydney, 9
Australia 10
3 Charles Perkins Centre, University of Sydney, Australia 11
4 Ministry of Health, NSW Office of Preventive Health, Sydney, Australia 12
5 The Better Health Company, Melbourne, Australia 13
14
Corresponding author 15
Gemma Enright 16
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown, NSW 17
Australia, 2050 18
T +61 2 8052 4505 19
E [email protected] 20
21
ABSTRACT 22
Introduction: Community-based weight management programs are important in 23
addressing childhood obesity. However, the mechanisms that lead to behaviour 24
change within the programs are rarely studied within the context of the programs 25
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2
themselves once they have been implemented. This means that further potential 1
gains in the effectiveness of the program are often not made and any potential 2
losses of efficacy are often not noticed. Qualitative research alongside randomised 3
controlled trials (RCTs) can tell us the context in which these programs are 4
implemented and elucidate potential mediators or modifiers of the programs’ 5
effectiveness. The aim of this evaluation is to determine the barriers and enablers to 6
the delivery and impact of an incentive-based behaviour change strategy targeting 7
child obesity to inform future translation. 8
Methods and analysis: Qualitative analysis including stakeholder and family 9
interviews, focus groups and a survey will be used. The research will be conducted 10
in collaboration with policy makers, researchers, and community health 11
professionals. Participants will be selected from program providers, and parents/ 12
carers and children participating in an Australian community weight management 13
program during an RCT examining the effectiveness of incentives for improving 14
behaviour change. A maximum variation sampling method based on participant 15
demographics and group characteristics will be used. Thematic analysis will be 16
carried out inductively based on emergent themes, using NVivo 9. 17
Ethics and dissemination: 18
This research is approved by the South West Sydney Human Ethics Committee 19
review body (HREC/14/LPOOL/480). The evaluation will provide information about 20
the contextual and influencing factors related to the outcomes of the RCT. The 21
results will assist researchers, community health practitioners and policy makers 22
regarding the development, implementation and translation of behaviour change 23
strategies in community initiatives for obese children. Insights gained may be 24
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applicable to a range of chronic conditions where similar preventive intervention 1
approaches are indicated. 2
3
STRENGTHS AND LIMITATIONS OF THIS STUDY 4
Strengths 5
• Qualitative design enables the collection of detailed perspectives from many 6
stakeholders and many participating families, allowing for triangulation of 7
findings. 8
• Analyses will be grounded in the data. This will allow potential for qualitative 9
information to add to our understanding of existing techniques for behaviour 10
change, as well as identify alternative causal pathways explaining behaviour 11
change related to goal setting and incentives 12
• .The evaluation design allows comparisons between the intervention and 13
control group sites, which will inform conclusions related to the generalisability 14
of the findings. 15
• The analysis is guided by the Behaviour Change Technique Taxonomy (BCTT 16
v1) [41] which will add to the robustness of the evaluation and increase the 17
possibly of identifying specific active components of the incentives scheme 18
and how they were effective. This will optimise translation of the effective 19
components and maximise the effectiveness of future interventions. 20
• Conducting the qualitative research shortly after the follow-up health 21
assessments of the associated RCT allows for data collection whilst the 22
program is still fresh in participants’ minds, whilst minimising contamination to 23
the RCT itself. 24
25
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Limitations 1
• There will be no opportunity in this design to carry out structured observations 2
of the intervention during the implementation phase itself since the trial has 3
been completed. However, project management materials such as decision 4
logs generated during the trial will be used as supporting data sources in the 5
process evaluation. 6
7
KEYWORDS 8
Childhood obesity, public health, incentives, behaviour change, qualitative 9
10
BACKGROUND 11
Childhood obesity is a global priority that many countries are currently trying to 12
address. In 2013 the number of overweight children under the age of five was 13
estimated to be over 42 million.[1] Overweight and obese children are likely to stay 14
obese into adulthood [2] and are more likely to develop chronic diseases like 15
diabetes and cardiovascular diseases at a younger age.[3] The increasing 16
prevalence also has implications for current and future health services.[4] Therefore 17
improving both the management and prevention of childhood obesity is extremely 18
important. 19
Community-based weight-management programs are an important response to 20
address childhood obesity, however although the specific behaviours required for 21
effective weight-loss and long-term behaviour change are well established,[5-10] 22
facilitating health-related behaviour change remains an on-going challenge. The 23
reasons for this are broadly twofold in that; (i) individuals (and particularly children) 24
find it difficult to make lasting health-related behaviour changes,[11,12] and (ii) 25
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associated implementation challenges mean health behaviour change interventions 1
based on behaviour change theory are often not up-scaled and translated into a 2
natural context.[8,12-14] 3
4
Difficulties associated with facilitating health-related behaviour change has led to an 5
increased emergence of research investigating whether incentive schemes, based 6
on behavioural theory such as operant conditioning,[15] might be a potential solution. 7
As such, promising research in adults has found that incentives can positively 8
influence health-related behaviour change in the short term.[16-18] For example, 9
several systematic reviews have demonstrated positive outcomes as a result of 10
financial incentives in terms of healthy eating,[19-21] and positive effects on exercise 11
behaviour.[22, 23] Many of the studies included in the reviews have acknowledged 12
the need for more research to determine specific information on the type, timing and 13
magnitude of incentives needed to motivate individuals to change their behaviour, as 14
well as disincentives.[19] There are also mixed findings on whether incentives are 15
more useful for simple one-off behaviours (e.g. attendance at a vaccination) rather 16
than complex health behaviours such as dietary behaviour change, and if specific 17
groups may benefit more from incentive schemes.[17] This highlights the need to 18
fully understand not only the cognitive influences on behaviour change, but also 19
social and environmental factors as well when designing and evaluating behaviour 20
change interventions, 21
22
Despite the growing body of evidence in adults, robust research investigating the 23
value of incentives focused on improving health-related behaviours in children is still 24
lacking. Several (uncontrolled) studies have highlighted the potential value of 25
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behavioural incentives in children and these studies have been summarised in a 1
recent narrative review.[24] One non-randomised study (n=1589) has demonstrated 2
that an incentive-program, based on lottery-style tickets, increased the probability of 3
children bike riding to school by 16%.[25] Three randomised studies (across 40 4
elementary schools) have reported that small rewards (such as stickers or low value 5
financial rewards) doubled the number of children consuming a serving of fruit or 6
vegetables with their school lunch,[26-28] and two of these studies found evidence of 7
sustained effects at two months [27] and six months [28] after the intervention. 8
However, these studies are based on small samples, the duration of the intervention 9
and follow-up tends to be short and inconsistent between studies (e.g. intervention 10
duration ranged from two to five weeks, and follow-up duration ranged from four 11
weeks to six months), they investigate a single health-related behaviour (i.e. either 12
diet or exercise) and there is no known qualitative research associated with the trials. 13
Before a systematic review can be performed and provide meaningful information on 14
the effectiveness of incentives for health-related behaviour in children, there is a 15
need for robustly designed trials to provide more evidence on for whom and in what 16
context incentive schemes might be most effective. 17
18
Whilst Randomised Controlled Trials (RCTs) are regarded as the gold standard for 19
establishing the effectiveness of interventions, RCTs are incompatible with 20
understanding how complex interventions work in context.[29] Effect sizes alone do 21
not provide policy makers with information on how an intervention might be 22
replicated in their specific context, whether intervention outcomes will be reproduced, 23
or the broader impact on participants’ lives.[30] Conducting a process evaluation 24
alongside a RCT provides a deep understanding of how interventions are 25
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implemented, what worked and didn’t work, and in which contexts it was most and 1
least effective and why.[31] In particular, qualitative research is extremely valuable 2
for understanding the more subjective nature of participants’ experiences and 3
determining what kind of change has occurred.[31,32]. As a relevant example, there 4
is a debate about whether extrinsic incentives can discourage the development of 5
intrinsic motivation and undermine the development of longer term habit 6
formation.[33] Qualitative research can provide invaluable information about the 7
disadvantages of using rewards to modify eating and exercise behaviour, which 8
should be fully considered in the design of behaviour change schemes for children. 9
Therefore, completion of a detailed qualitative process evaluation will facilitate the 10
translation of knowledge from clinical research with children, and help guide how 11
effective incentive strategies could be optimally implemented into routine practice for 12
addressing childhood obesity. Furthermore, using a framework for deconstructing 13
and specifying various intervention components within a process evaluation will 14
enable the active components of the intervention that change behaviour to be 15
isolated, along with underlying mediators of action, effective modes of delivery, and 16
the most receptive populations.[34 ] This will facilitate replication of the interventions 17
into community health settings, inform resource allocation, and advance intervention 18
science . 19
20
In summary, managing childhood obesity is a global priority. There is a gap in the 21
evidence base on the impact of incentives on health behaviours in children, and 22
qualitative research can provide rich contextual information to help the interpretation 23
of child-focused obesity intervention delivery and outcomes. The overall aim of this 24
research is to provide detailed information on the barriers and enablers to the 25
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intended delivery and outcomes of a child-focused incentives-based scheme, and 1
determine whether the scheme is an acceptable intervention to improve behaviour 2
change in overweight and obese children. This qualitative information will be used to 3
build the evidence base and inform policy and practice. Specific aims of this 4
research are to: 5
1. Identify what factors influenced implementation fidelity of the scheme to; 6
a. determine whether the incentives scheme was implemented as 7
intended; 8
b. determine whether the model of goal-setting and incentives enhances 9
an existing community weight management program; 10
c. understand how the implementation process might be improved. 11
2. Identify what factors influenced intervention outcomes and the broader impact 12
on participants’ lives to; 13
a. determine for whom and in what context the incentives scheme was 14
effective. 15
3. Identify the active components of the intervention that influenced behaviour, 16
to: 17
a. determine which intervention components were the most effective; 18
b. determine any components that are unnecessary; 19
c. identify components that were non effective but may be useful. 20
21
MEHODS/ DESIGN 22
Setting 23
This qualitative evaluation research will be conducted shortly after the follow-up six-24
month data collection point of a RCT conducted in New South Wales Australia from 25
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2014 to mid-2016. The details of the RCT design are described elsewhere.[35] In 1
summary, the RCT intervention (n=524 children and 38 community-based program 2
sites across five local health districts) is a cluster RCT which tested the use of 3
incentives linked to goal setting for sustained behaviour change in overweight and 4
obese children aged 7-13. The RCT was set within the context of an existing 5
Australian community-based weight management program. 6
7
The weight management program, ‘Go4Fun’, is a free, voluntary program run by 8
health professionals, addressing weight-related behaviour and self-esteem for 9
overweight or obese children aged 7-13 years. Go4Fun is based on the Mind 10
Exercise Nutrition Do-it (MEND) child weight management program in the UK, which 11
has demonstrated efficacy in weight outcomes (reduced waist and body mass index 12
measures, and improvements in physical activity and self-esteem).[36] The program 13
is multidisciplinary and evidence-based, and incorporates elements recognised as 14
important to achieve long-term behaviour changes, such as family involvement, 15
practical education in nutrition and diet, and increasing physical activity.[7, 8] Control 16
sites in the trial delivered the standard weight management program content 17
consisting of weekly two-hour group sessions for 10 weeks during the school term. 18
Intervention sites delivered the standard program together with an enhanced goal 19
setting and structured incentive scheme for goal achievement. This was supported in 20
the six months following the program by weekly text messages and a lucky-draw 21
style incentive. 22
23
Participants 24
The participants in this evaluation will come from two groups. 25
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First, existing participants in the RCT (parents/ carers and their children), who have 1
consented to being invited to further research. These were recruited for the 2
evaluation via a brief survey given to parents/ carers during the six-month follow-up 3
health assessments in the RCT. All children who participated in the RCT were aged 4
7-13 years at the time of the trial, had a body mass index greater than the 85th 5
percentile for their age and gender (according to the Centre for Disease Control 6
classification of overweight/ obesity in children,[37]) were enrolled in and met the 7
criteria to participate in the community weight management program at one of the 8
sites that participated in the study. Families self-referred via a toll-free phone 9
number, text message or online registration to the program, and secondary referrals 10
were accepted from health professionals, organisations and community members. 11
Eligibility was assessed at the time of referral or contact with local health districts 12
and based on anthropometric measures and a medical questionnaire completed by a 13
parent/ carer, who also provided written consent for their child to participate in the 14
research. 15
A maximum variation sampling method based on the community weight 16
management program participant demographics and program group characteristics 17
will be used in the evaluation. In the sample of parents/ carers and children we will 18
aim to include; high and low attendance (</>50%) in the weight management 19
program, single child and multiple sibling families, participants from smaller program 20
groups (<six children) and larger program groups (>eight children). A variation of 21
ethnicity, culturally and linguistically diverse (CALD) and socioeconomic status (SES) 22
characteristics will also be included. 23
Second, participants in the evaluation shall be stakeholders who were involved in the 24
delivery of the RCT, including; public servants, policy makers, behavioural 25
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specialists, program managers for local health districts, and community health 1
professionals. These shall be selected, beginning with core stakeholders who were 2
directly involved in the design and implementation of the RCT, and informed by the 3
research data collection as it progresses. 4
5
Design 6
Logic model 7
The logic model (Figure 1) shows the aspects most critical to the success of the 8
RCT, to guide this evaluation. The logic model shows the intended inputs and 9
activities involved in implementing the incentives-based intervention as well as the 10
intended outcomes and broader impacts 11
12
Levels of evaluation and how they relate to the Logic model 13
To address each of the three aims, three levels of qualitative evaluation will be 14
conducted: (i) process, (ii) impact, and (iii) intervention deconstruction. The 15
evaluation plan is summarised in Table 1. 16
17
Table 1. Evaluation plan 18
Aim
Levels of evaluation and how they relate to Logic model
Evaluation component
Data source Timing of data collection
1. Identify what factors influenced implementation fidelity
Level: Process evaluation Relates to intended activities and
Content delivery (stakeholders) Content engagement
Combination of: Stakeholder interviews
Within two months after the six month follow-up health assessments
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outputs in the logic model
(participants) Reach
Survey of parents/ carers Focus groups with parents/ carers Family interviews Decision logs, implementation plans and other project management documentation
of the RCT (estimated to commence Aug/ Sept 2016) The survey of parents/ carers was distributed and collected from all parents/ carers during the six month health assessments (May/ June 2016)
2. Identify what factors influenced behaviour change and the broader impact on participants’ lives
Level: Impact evaluation Relates to intended outcomes and impacts in the logic model
The broader environment Key participant characteristics Program factors
Combination of: Focus groups with parents/ carers Family interviews
Within two months after the six month follow-up health assessments as part of the RCT (estimated to commence Aug/ Sept 2016)
3. Identify the active components of the intervention that influenced behaviour
Intervention deconstruction
Behaviour change intervention components
Transcripts generated from focus groups and interviews
On completion of aims 1 and 2 (estimated early 2017)
1
Aim 1. Process evaluation 2
The process evaluation will determine the degree the incentives-based intervention 3
was implemented as intended (implementation fidelity). The evaluation will document 4
factors influencing how the different components of the intervention were delivered 5
and received from the perspectives of those delivering and receiving the intervention, 6
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and compare this with intended implementation by the trial Stakeholder Working 1
Group (see Acknowledgements). 2
3
The framework used to guide the design of the process evaluation was the 4
Normalisation Process Theory.[38] Normalisation Process Theory provides a 5
conceptual framework for understanding the processes by which interventions are 6
implemented and integrated into everyday practice. The model explores factors 7
involved in the dynamics between people delivering and receiving an intervention in 8
order to account for outcomes of the implementation process, and differences 9
between expected and observed outcomes in real settings. In implementing an 10
intervention in a natural setting Normalisation Process Theory argues that people 11
need to continuously make sense of the work they are doing (coherence), engage 12
with it (cognitive participation), enact it (collective action), and reflect on it (reflective 13
monitoring). With an emphasis on exploring these concepts the process evaluation 14
will look at three evaluation components. These are: (i) content delivery, (ii) content 15
engagement, and (iii) reach, and are shown in Table 1. Content delivery refers to the 16
delivery and receipt of each individual input component of the intervention from the 17
perspective of those delivering the intervention. Content engagement refers to the 18
delivery and receipt of each component of the intervention from the perspective of 19
those receiving the intervention. Reach refers to the proportion of the intended target 20
audience who participated in the intervention, and the process evaluation will 21
specifically explore reasons expressed for discontinuing the program. 22
23
Information collected from stakeholders (those implementing the intervention) will 24
include perceptions on the roles and activities involved in the implementation of the 25
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intervention, from initial discussions through to intervention design, set-up, project 1
management and facilitation. Perceptions on the acceptability, including integration 2
and disruption to the standard community program, benefits and impacts of the 3
intervention and suggestions for improvement will also be collected. 4
Information collected from participants (parents/ carers and children receiving the 5
intervention) will include perceptions on how specific components of the intervention 6
were understood and engaged with, and recounts of their experiences of interacting 7
with the intervention materials, other families and facilitators. Perceived benefits, 8
strengths/ weaknesses and suggested improvements will also be collected. 9
10
Aim 2. Impact evaluation 11
The impact evaluation will determine the contextual factors that influenced trial 12
outcomes and broader impacts, and identify for whom the incentive scheme was 13
most and least effective in terms of having an effect during the community weight 14
management program and sustained impacts after the program. Investigations will 15
include the environmental and social context associated with participation in the 16
intervention, individual attitudes and beliefs about healthy living, and associated 17
barriers and enablers to adapting to new behaviours and forming new habits 18
19
The Realistic Evaluation model [39] was used to inform the design of the impact 20
evaluation and Table 1 outlines the three evaluation components the investigation 21
will focus on. These are: the broader environment, participant characteristics, and 22
program factors. The broader environment refers to other health activity, particularly 23
other interventions and healthy eating programs the family was involved in at the 24
time of the intervention, as well as barriers and enablers to participation and 25
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engagement in the community weight management program associated with the 1
home environment and the families’ lifestyle. Participant characteristics were 2
identified at baseline in the trial and include; age, gender, single or separated family 3
status, single or multiple sibling family. This information will be used to recruit 4
participants for focus groups and family interviews (with the aim of including a mix of 5
characteristics), and will also be factored into analyses. Program factors to be 6
explored include; size of the community weight management program group, 7
regional or metro site location, venue type, and day the program sessions were held 8
(weekday or a weekend day), and will also be informed by the process evaluation. 9
10
Information collected will draw from those receiving the intervention (children and 11
their parents/ carers), and include lifestyles, attitudes and health behaviours, 12
perceptions on what has changed in their lives since the program, habits retained, 13
and behaviours that have proven difficult to integrate into their lifestyles. Specific 14
impacts of the individual intervention components will be explored in depth. 15
All intended primary and secondary outcomes of the trial will be considered in the 16
investigation of contextual factors. The primary measure in the RCT was body mass 17
index at the end of the community weight management program (10 weeks) and at 18
six months. Secondary outcomes included: Waist circumference; nutrition and 19
physical activity behaviours and self-esteem (by survey) at the end of program (10 20
weeks) and at six months. Attendance rates during the program (completion of >75% 21
of sessions) was also measured in the trial. The evaluation will also compare 22
perceptions of the incentives scheme in relation to the outcomes in the absence of 23
the intervention (control group). This will help determine how the intervention 24
influenced outcomes, and whether the effects were intended. 25
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1
Aim 3.Intervention deconstruction 2
The intervention deconstruction will explore and describe which specific components 3
of the incentives-based intervention were most impactful and why. The incentives 4
intervention was developed iteratively in 2014 drawing from a review of the relevant 5
literature, workshops, focus groups and field visits. Combined literature review and 6
advice from community program leaders highlighted the importance of incentivising 7
goals and activities (e.g. having healthier lunches) rather than outcomes (e.g. weight 8
loss) for greater impact on behaviour change.[40,11] For example, in a series of 9
RCTs across 203 elementary schools, it was reported that providing incentives for 10
reading books was more effective than providing incentives for outcomes such as 11
scores on a test.[40] Community program leaders indicated during field research that 12
while goal setting as part of the program was usually specific, measureable, 13
achievable, relevant, and timely (SMART), it was likely to be of value to enhance the 14
goal setting process, including resetting/ stretching goals if they are achieved too 15
easily, and linking goal achievement to incentives. The importance of choosing the 16
appropriate size, type and timing of incentives was also highlighted as critical for 17
motivating change. For example, a study in children [26] found that a larger financial 18
reward (a US quarter rather than a nickel) combined with receiving it on the same 19
day as the behaviour was performed produced the largest behaviour change. The 20
key behavioural concepts that informed the design of the individual intervention 21
components (inputs in the logic model) are summarised below in Table 2. 22
23
The Behaviour Change Technique Taxonomy (BCTTv1) [41] will be used as a 24
framework for deconstructing the behaviour change intervention components used in 25
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the trial. The purpose of this is threefold: (i) to optimise the robustness and 1
replication potential of the research by using a common language to recognise and 2
specify the components of the intervention that are changing behaviour (use of the 3
taxonomy supports the CONSORT guidelines for the reporting of behaviour change 4
interventions,[42] (ii) to facilitate translation of the interventions for the greatest effect 5
on child obesity outcomes by separating the active ingredients within the intervention 6
components and the conditions under which they are effective, from components 7
that may be less necessary and (iii) to understand more about any intervention 8
components that may be useful but were not sufficient in dose to produce an impact 9
on outcomes.[34] It will also be useful to refer to the full list of 93 items in the 10
Behaviour Change Technique Taxonomy [41] in the analysis of how and why specific 11
components worked or didn’t work. The behaviour change technique mappings 12
shown below in Table 2 have been mapped in retrospect as a starting point to guide 13
analysis. For this exercise careful attention was paid to the coding definitions 14
specified in the Behaviour Change Technique Taxonomy,[41] and the “BCT 15
taxonomy” app was downloaded through Apple to guide coding. 16
17
Table 2. Behavioural concepts and corresponding behaviour change intervention 18
components, mapped to the Behaviour Change Technique Taxonomy. 19
*Corresponds with Inputs (material resources) and Activities in the logic model 20
Concept to illicit behaviour change
Behaviour change intervention component developed for the trial*
Mapped to the Behaviour Change Technique Taxonomy [41]
Incentivising behaviours and activities rather than outcomes is more effective for sustained behaviour change than rewarding outcomes [33,40,43]
Enhanced goal setting process including establishing a "big wish” (the overall outcome), then deciding on small achievable weekly goals which were re-set and stretched each week (with modified SMART goals handout)
Goals and Planning (1.4 action planning) Note 8.3 Habit formation and 8.7Graded tasks may also apply
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Rewards scheme linked to weekly nutrition and exercise goal attainment
Reward and Threat (10.1 material reward (behaviour)
People are motivated to complete a goal when they can see their progress [44]
Group “Goals and Rewards Tracker”
Feedback and monitoring (2.5 monitoring of outcomes of behaviour without feedback)
Small and frequent rewards can increase task perseverance [44]
Low value weekly rewards
Reward and Threat (10.1 material reward (behaviour)
An implementation intention can help people achieve a goal [45-47)
Modified “Goals and Rewards Contract”(between parent/ carer and child)
Goals and Planning –(1.8 behavioural contract )
Lucky draw-style rewards may increase effectiveness of incentives [17,22,25]
Prize draw incentive six months after community weight management program
Reward and Threat –(anticipation of future reward – not categorised by the app used to code)
Text message prompts w can improve health behaviours [48]
SMS scheme linked to six month prize draw
Feedback and Monitoring (10.4 social reward)
1
Data Sources 2
The evaluation will use a qualitative analysis, which will explore multiple groups of 3
people’s perspectives on the benefits, acceptability, and other ways in which 4
incentives could be used for behaviour change. Data collection will include a 5
combination of focus groups, family and stakeholder interviews, and a survey. Table 6
3 provides details of the data sources and their aims. 7
8
Table 3. Summary of data sources and their aims 9
Data source Scope Recruited by Aim 1.Survey of parents/ carers who participated in the community program
A 5-minute written survey of 10 questions with a mix of open-ended, single and multiple response questions. One per parent/ carer (control and
Distribution and collection at the six month health assessments of the trial
Focus: overall barriers and enablers to behaviour change, and recruitment Obtain top of mind feedback on core elements of the intervention, and
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treatment) invite families to consent to be contacted for a focus group or family interview
2. Focus groups with parents/ carers
4-6 groups, lasting 30-60mins, with 6-8 participants depending on thematic saturation
Brief survey. Selection will be based on quota specifications around key participant and group characteristics (see ‘Participants’)
Focus: process evaluation Explore experiences, perceptions and engagement in the specific intervention component
3. Family interviews with parents/ carers and their children who participated in the community program, and other family members (e.g. siblings)
10-20 interviews lasting 30-60mins, depending on thematic saturation
Brief survey. Selection will be based on quota specifications around key participant and group characteristics (see ‘Participants’)
Focus: impact evaluation Gain insights into the contextual factors influencing outcomes
4. Stakeholder interviews
10 individual or group interviews depending on thematic saturation
Phone calls made by GE. Stakeholders will be targeted according to quotas based on roles in the various design and implementation stages of the RCT
Focus: process evaluation Understand issues associated with the intended and actual delivery of the intervention
5.Project management materials
Decision logs, implementation plans and other project management documentation
Retracing project management activity, stored securely at the Department of Premier and Cabinet)
Collect additional insight into issues, mitigations, processes and learnings documented by the project team throughout the trial
1
The focus groups and interviews will follow a semi-structured approach, and 2
facilitation will be supported by bullet-pointed topic guides to facilitate natural 3
conversation between moderator and participants by emphasising topics, objectives 4
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and flow. Each focus group and interview will be recorded and transcribed verbatim. 1
Participants will be made aware of this at the start of the group or interview and their 2
consent obtained. All discussions will be confidential. GE will conduct the focus 3
groups and interviews in a private room within a facility near to the participants’ 4
residence (such as a community centre) or place of work. A second researcher will 5
also be present in the room in an observatory capacity to take notes during the group 6
discussion. Refreshments and parking reimbursement will be provided for focus 7
group participants. To optimise attendance a $40 (e.g. a supermarket voucher) will 8
be offered to each family who participates in an interview. 9
10
Data analysis and synthesis 11
Data analysis and synthesis will be based on the Grounded Theory approach.[49-51] 12
Qualitative data from focus groups, family and stakeholder interviews, and the 13
survey will be transcribed and systematically coded, drawing out the key points. 14
Similar codes will be grouped into concepts and categories based on emergent 15
themes. The coding process will begin with the first interview and be repeated for 16
each subsequent interview or focus group with the use of field notes, memos and 17
constant comparison to accumulate ideas about how concepts relate to each other. 18
For each transcript examples will be extracted that either confirm or contradict the 19
emerging themes. Once thematic saturation occurs, no further interviews and focus 20
groups will be necessary. Two researchers will conduct the analysis, and if at any 21
stage consensus cannot be reached, a third researcher will review those aspects. 22
NVivo software will be used to assist with qualitative data management. The overall 23
output will be a set of probability statements about the relationship between 24
concepts, or a set of conceptual hypotheses [50] about the barriers and enablers to 25
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implementation of the incentives scheme, and its impact on the behaviour of 1
participants. 2
3
The analysis will be conducted in three waves, corresponding to the three levels of 4
evaluation in this research - the process, impact and behaviour change component 5
evaluations. Specifically, for the process evaluation the coding process will refer 6
back to the individual input and activity components in the logic model. Each focus 7
group and interview transcript will be scanned for themes relating to the delivery and 8
receipt of each component of the incentives scheme. Project management materials 9
will also be reviewed and examples identified to support or contradict themes 10
emerging from the transcribed data. For the impact evaluation the coding process 11
will be related back to the intended outcomes and impacts of the intervention, as per 12
the logic model. Each focus group and interview transcript will be scanned for 13
themes associated with broader environmental influences on the effects of the 14
incentive scheme, and in relation to different participant characteristics and program 15
factors. The output will include typologies to describe for whom and how incentives 16
may impact behaviour. The intervention deconstruction will be guided by the 17
Behaviour Change Technique Taxonomy [41] as a basis for describing the active 18
intervention components and exploring whether the perceived impacts of the 19
intervention support or contradict the behavioural concepts underlying the design of 20
intervention. The specific mechanisms of the incentives-based behaviour change 21
scheme that lead to behaviour change may be associated with behavioural concepts 22
outside of those identified in the literature and influenced by unanticipated factors, 23
which the researchers will explore throughout the analysis. 24
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The findings will be triangulated, drawing on the variety of data sources and 1
perspectives, and with comparison to the trial control group to determine whether the 2
trial outcomes can be attributed to the intervention. Issues and potential biases in the 3
design of the trial will be carefully factored in to interpretations. 4
5
Timing of data collection 6
The timing of the data collection is shown above in Table 1. Data will be collected at 7
two points: (i) during the six-month follow-up assessments in the RCT (which is 8
complete), (ii) one to two months after the six-month assessments. Conducting the 9
fieldwork close to the follow-up assessments will minimise corruption of the RCT as 10
the evaluation data collection will prompt people to remember their experiences 11
during a pre-scheduled intervention point. Focus groups and stakeholder and family 12
interviews are estimated to commence in August 2016. 13
14
DISCUSSION 15
This paper details the protocol for a qualitative evaluation to be conducted shortly 16
following a RCT aimed at increasing behaviour change in overweight and obese 17
children participating in a community-based obesity program. The research aims to 18
address the challenges of public health interventions and provide information about 19
the barriers and enablers to the implementation of an incentives-based intervention 20
and its impact on health-related behaviour change in children. This research will 21
determine the relationships between intervention delivery, contextual factors 22
influencing outcomes, and the mechanisms of behaviour change, and provide 23
detailed information on the acceptability of the incentives-based scheme and its 24
potential as an obesity-reducing strategy in children in a range of contexts. It has 25
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potential to add considerable value to the interpretation of the quantitative-based 1
RCT outcomes and inform future implementation and translation as a behaviour 2
change strategy for managing obesity in overweight children, should the 3
interventions be deemed acceptable. The knowledge will also advance the 4
development of further strategies for health-related behavior change in children, 5
supporting positive change in tackling the growing global problem of obesity. 6
7
DECLARATIONS 8
Ethics approval and consent to participate 9
The study has been approved by the South West Sydney Human Ethics Committee 10
review body (HREC/14/LPOOL/480). Appropriate site-specific approvals have been 11
obtained from relevant research governance offices. Consent was obtained from 12
existing RCT participants during the trial to be contacted for qualitative research. 13
14
Competing interests 15
None known 16
17
Authors’ contributions 18
GE led the drafting of all sections of the article in consultation with all the co-authors. 19
JR/ GE led the application for funding for this work. All authors provided substantial 20
contribution to the concept and design of the evaluation, drafting the protocol paper 21
and reviewing critically for important intellectual content and final approval of the 22
version for publication. 23
24
Funding 25
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This research is funded in-kind provided by the George Institute for Global Health 1
and the Department for Premier and Cabinet. GE is funded by a PhD scholarship 2
through the George Institute for Global Health within the NHMRC program grant 3
ID1052555. JR is funded by a Career Development and Future Leader Fellowship 4
co-funded by the National Health and Medical Research Council and the National 5
Heart Foundation. AR is funded by an NHMRC Principal Research Fellowship 6
APP1124780. JR and AR are investigators on NHMRC program grant ID1052555. 7
8
Acknowledgements 9
This evaluation would not have been possible without the contributions of the RCT 10
investigator team and Working Group. Investigators and Working Group members 11
who are not co-authors on this paper, and their affiliates are listed below: 12
• Office of Preventive Health: Anita Cowlishaw; Santosh Kanal; Nicholas 13
Petrunoff 14
• Behavioural Insights Unit, Department of Premier and Cabinet: Shirley Dang 15
• Western Sydney LHD: Christine Newman; Michelle Nolan; Deborah Benson, 16
Kirsti Cunningham 17
• South Western Sydney LHD: Mandy Williams; Leah Choi; Kate Jesus; 18
Stephanie Baker 19
• South Eastern Sydney LHD: Myna Hua; Linda Trotter; Lisa Franco 20
• North Sydney LHD: Paul Klarenaar; Jonothan Noyes; Sakara Branson 21
• Hunter New England LHD: Karen Gillham; Dr John Wiggers; Silvia Ruano-22
McLerie 23
• Mid North Coast LHD: Ros Tockley; Margo Johnson 24
• Better Health Company; Madeline Freeman; Bec Thorp 25
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• The George Institute for Global Health; Sarah Eriksson; Caroline Wu 1
In addition we thank the Go4Fun program leaders, and representatives from our 2
funding partner organisations, including the Heart Foundation, who have contributed 3
to the development and implementation of the RCT. 4
5
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Figure 1. Behavioural incentives intervention logic model
Figure 1.
346x210mm (300 x 300 DPI)
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Evaluating factors influencing the delivery and outcomes of an incentive-based behaviour change strategy targeting
child obesity: Protocol for a qualitative process and impact evaluation
Journal: BMJ Open
Manuscript ID bmjopen-2016-012536.R2
Article Type: Protocol
Date Submitted by the Author: 13-Oct-2016
Complete List of Authors: Enright, Gemma; Cardiovascular Divsion Gyani, Alex; NSW Department of Premier and Cabinet, Behavioural Insights Unit Raadsma, Simon; NSW Department of Premier and Cabinet, Behavioural Insights Unit Allman-Farinelli, Margaret; University of Sydney, Faculty of Science Rissel, Chris; Ministry of Health, NSW Office of Preventative Health, Innes-Hughes, Christine; Ministry of Health, NSW Office of Preventative Health, Lukeis, Sarah; The Better Health Company
Rodgers, Anthony; The George Institute for Global Health, Sydney Medical School, University of Sydney, Redfern, Julie; The George Institute for Global Health, Sydney Medical School, University of Sydney, Cardiovascular Division
<b>Primary Subject Heading</b>:
Public health
Secondary Subject Heading: Qualitative research, Health policy
Keywords: Community child health < PAEDIATRICS, PUBLIC HEALTH, QUALITATIVE RESEARCH
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1
Evaluating factors influencing the delivery and outcomes of an incentive-1
based behaviour change strategy targeting child obesity: Protocol for a 2
qualitative process and impact evaluation 3
Gemma Enright1, 2, Alex Gyani2, Simon Raadsma2, Margaret Allman-Farinelli3, Chris 4
Rissel4, Christine Innes-Hughes4, Sarah Lukeis5, Anthony Rodgers1, Julie Redfern1 5
6
1 The George Institute for Global Health (Cardiovascular Division), Sydney Medical 7
School, University of Sydney, Australia 8
2 NSW Department of Premier and Cabinet, Behavioural Insights Unit, Sydney, 9
Australia 10
3 Charles Perkins Centre, University of Sydney, Australia 11
4 Ministry of Health, NSW Office of Preventive Health, Sydney, Australia 12
5 The Better Health Company, Melbourne, Australia 13
14
Corresponding author 15
Gemma Enright 16
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown, NSW 17
Australia, 2050 18
T +61 2 8052 4505 19
E [email protected] 20
21
ABSTRACT 22
Introduction: Community-based weight management programs are important in 23
addressing childhood obesity. However, the mechanisms that lead to behaviour 24
change within the programs are rarely studied within the context of the programs 25
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themselves once they have been implemented. This means that further potential 1
gains in the effectiveness of the program are often not made and any potential 2
losses of efficacy are often not noticed. Qualitative research alongside randomised 3
controlled trials (RCTs) can tell us the context in which these programs are 4
implemented and elucidate potential mediators or modifiers of the programs’ 5
effectiveness. The aim of this evaluation is to determine the barriers and enablers to 6
the delivery and impact of an incentive-based behaviour change strategy targeting 7
child obesity to inform future translation. 8
Methods and analysis: Qualitative analysis including stakeholder and family 9
interviews, focus groups and a survey will be used. The research will be conducted 10
in collaboration with policy makers, researchers, and community health 11
professionals. Participants will be selected from program providers, and parents/ 12
carers and children participating in an Australian community weight management 13
program during an RCT examining the effectiveness of incentives for improving 14
behaviour change. A maximum variation sampling method based on participant 15
demographics and group characteristics will be used. Thematic analysis will be 16
carried out inductively based on emergent themes, using NVivo 9. 17
Ethics and dissemination: 18
This research is approved by the South West Sydney Human Ethics Committee 19
review body (HREC/14/LPOOL/480). The evaluation will provide information about 20
the contextual and influencing factors related to the outcomes of the RCT. The 21
results will assist researchers, community health practitioners and policy makers 22
regarding the development, implementation and translation of behaviour change 23
strategies in community initiatives for obese children. Insights gained may be 24
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applicable to a range of chronic conditions where similar preventive intervention 1
approaches are indicated. 2
3
STRENGTHS AND LIMITATIONS OF THIS STUDY 4
Strengths 5
• Qualitative data collection of multiple perspectives allows for triangulation of 6
findings. 7
• This process evaluation will enhance our understanding of implementation 8
and identify causal pathways explaining behaviour change. 9
• Comparison between the intervention and control group sites will inform 10
generalisability of the findings. 11
• Considering behaviour change theory will increase the possibly of identifying 12
specific active components of the incentives scheme and how they were 13
effective. 14
Limitations 15
• There will be no opportunity in this design to carry out structured observations 16
of the intervention during the implementation phase 17
18
KEYWORDS 19
Childhood obesity, public health, incentives, behaviour change, qualitative 20
21
BACKGROUND 22
Childhood obesity is a global priority that many countries are currently trying to 23
address. In 2013 the number of overweight children under the age of five was 24
estimated to be over 42 million.[1] Overweight and obese children are likely to stay 25
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obese into adulthood [2] and are more likely to develop chronic diseases like 1
diabetes and cardiovascular diseases at a younger age.[3] The increasing 2
prevalence also has implications for current and future health services.[4] Therefore 3
improving both the management and prevention of childhood obesity is extremely 4
important. 5
Community-based weight-management programs are an important response to 6
address childhood obesity, however although the specific behaviours required for 7
effective weight-loss and long-term behaviour change are well established,[5-10] 8
facilitating health-related behaviour change remains an on-going challenge. The 9
reasons for this are broadly twofold in that; (i) individuals (and particularly children) 10
find it difficult to make lasting health-related behaviour changes,[11,12] and (ii) 11
associated implementation challenges mean health behaviour change interventions 12
based on behaviour change theory are often not up-scaled and translated into a 13
natural context.[8,12-14] 14
15
Difficulties associated with facilitating health-related behaviour change has led to an 16
increased emergence of research investigating whether incentive schemes, based 17
on behavioural theory such as operant conditioning,[15] might be a potential solution. 18
As such, promising research in adults has found that incentives can positively 19
influence health-related behaviour change in the short term.[16-18] For example, 20
several systematic reviews have demonstrated positive outcomes as a result of 21
financial incentives in terms of healthy eating,[19-21] and positive effects on exercise 22
behaviour.[22, 23] Many of the studies included in the reviews have acknowledged 23
the need for more research to determine specific information on the type, timing and 24
magnitude of incentives needed to motivate individuals to change their behaviour, as 25
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well as disincentives.[19] There are also mixed findings on whether incentives are 1
more useful for simple one-off behaviours (e.g. attendance at a vaccination) rather 2
than complex health behaviours such as dietary behaviour change, and if specific 3
groups may benefit more from incentive schemes.[17] This highlights the need to 4
fully understand not only the cognitive influences on behaviour change, but also 5
social and environmental factors as well when designing and evaluating behaviour 6
change interventions, 7
8
Despite the growing body of evidence in adults, robust research investigating the 9
value of incentives focused on improving health-related behaviours in children is still 10
lacking. Several (uncontrolled) studies have highlighted the potential value of 11
behavioural incentives in children and these studies have been summarised in a 12
recent narrative review.[24] One non-randomised study (n=1589) has demonstrated 13
that an incentive-program, based on lottery-style tickets, increased the probability of 14
children bike riding to school by 16%.[25] Three randomised studies (across 40 15
elementary schools) have reported that small rewards (such as stickers or low value 16
financial rewards) doubled the number of children consuming a serving of fruit or 17
vegetables with their school lunch,[26-28] and two of these studies found evidence of 18
sustained effects at two months [27] and six months [28] after the intervention. 19
However, these studies are based on small samples, the duration of the intervention 20
and follow-up tends to be short and inconsistent between studies (e.g. intervention 21
duration ranged from two to five weeks, and follow-up duration ranged from four 22
weeks to six months), they investigate a single health-related behaviour (i.e. either 23
diet or exercise) and there is no known qualitative research associated with the trials. 24
Before a systematic review can be performed and provide meaningful information on 25
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the effectiveness of incentives for health-related behaviour in children, there is a 1
need for robustly designed trials to provide more evidence on for whom and in what 2
context incentive schemes might be most effective. 3
4
Whilst Randomised Controlled Trials (RCTs) are regarded as the gold standard for 5
establishing the effectiveness of interventions, RCTs are incompatible with 6
understanding how complex interventions work in context.[29] Effect sizes alone do 7
not provide policy makers with information on how an intervention might be 8
replicated in their specific context, whether intervention outcomes will be reproduced, 9
or the broader impact on participants’ lives.[30] Conducting a process evaluation 10
alongside a RCT provides a deep understanding of how interventions are 11
implemented, what worked and didn’t work, and in which contexts it was most and 12
least effective and why.[31] In particular, qualitative research is extremely valuable 13
for understanding the more subjective nature of participants’ experiences and 14
determining what kind of change has occurred.[31,32]. As a relevant example, there 15
is a debate about whether extrinsic incentives can discourage the development of 16
intrinsic motivation and undermine the development of longer term habit 17
formation.[33] Qualitative research can provide invaluable information about the 18
disadvantages of using rewards to modify eating and exercise behaviour, which 19
should be fully considered in the design of behaviour change schemes for children. 20
Therefore, completion of a detailed qualitative process evaluation will facilitate the 21
translation of knowledge from clinical research with children, and help guide how 22
effective incentive strategies could be optimally implemented into routine practice for 23
addressing childhood obesity. Furthermore, using a framework for deconstructing 24
and specifying various intervention components within a process evaluation will 25
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enable the active components of the intervention that change behaviour to be 1
isolated, along with underlying mediators of action, effective modes of delivery, and 2
the most receptive populations.[34 ] This will facilitate replication of the interventions 3
into community health settings, inform resource allocation, and advance intervention 4
science . 5
6
In summary, managing childhood obesity is a global priority. There is a gap in the 7
evidence base on the impact of incentives on health behaviours in children, and 8
qualitative research can provide rich contextual information to help the interpretation 9
of child-focused obesity intervention delivery and outcomes. The overall aim of this 10
research is to provide detailed information on the barriers and enablers to the 11
intended delivery and outcomes of a child-focused incentives-based scheme, and 12
determine whether the scheme is an acceptable intervention to improve behaviour 13
change in overweight and obese children. This qualitative information will be used to 14
build the evidence base and inform policy and practice. Specific aims of this 15
research are to: 16
1. Identify what factors influenced implementation fidelity of the scheme to; 17
a. determine whether the incentives scheme was implemented as 18
intended; 19
b. determine whether the model of goal-setting and incentives enhances 20
an existing community weight management program; 21
c. understand how the implementation process might be improved. 22
2. Identify what factors influenced intervention outcomes and the broader impact 23
on participants’ lives to; 24
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a. determine for whom and in what context the incentives scheme was 1
effective. 2
3. Identify the active components of the intervention that influenced behaviour, 3
to: 4
a. determine which intervention components were the most effective; 5
b. determine any components that are unnecessary; 6
c. identify components that were non effective but may be useful. 7
8
MEHODS/ DESIGN 9
Setting 10
This qualitative evaluation research will be conducted shortly after the follow-up six-11
month data collection point of a RCT conducted in New South Wales Australia from 12
2014 to mid-2016. The details of the RCT design are described elsewhere.[35] In 13
summary, the RCT intervention (n=524 children and 38 community-based program 14
sites across five local health districts) is a cluster RCT which tested the use of 15
incentives linked to goal setting for sustained behaviour change in overweight and 16
obese children aged 7-13. The RCT was set within the context of an existing 17
Australian community-based weight management program. 18
19
The weight management program, ‘Go4Fun’, is a free, voluntary program run by 20
health professionals, addressing weight-related behaviour and self-esteem for 21
overweight or obese children aged 7-13 years. Go4Fun is based on the Mind 22
Exercise Nutrition Do-it (MEND) child weight management program in the UK, which 23
has demonstrated efficacy in weight outcomes (reduced waist and body mass index 24
measures, and improvements in physical activity and self-esteem).[36] The program 25
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is multidisciplinary and evidence-based, and incorporates elements recognised as 1
important to achieve long-term behaviour changes, such as family involvement, 2
practical education in nutrition and diet, and increasing physical activity.[7, 8] Control 3
sites in the trial delivered the standard weight management program content 4
consisting of weekly two-hour group sessions for 10 weeks during the school term. 5
Intervention sites delivered the standard program together with an enhanced goal 6
setting and structured incentive scheme for goal achievement. This was supported in 7
the six months following the program by weekly text messages and a lucky-draw 8
style incentive. 9
10
Participants 11
The participants in this evaluation will come from two groups. 12
First, existing participants in the RCT (parents/ carers and their children), who have 13
consented to being invited to further research. These were recruited for the 14
evaluation via a brief survey given to parents/ carers during the six-month follow-up 15
health assessments in the RCT. All children who participated in the RCT were aged 16
7-13 years at the time of the trial, had a body mass index greater than the 85th 17
percentile for their age and gender (according to the Centre for Disease Control 18
classification of overweight/ obesity in children,[37]) were enrolled in and met the 19
criteria to participate in the community weight management program at one of the 20
sites that participated in the study. Families self-referred via a toll-free phone 21
number, text message or online registration to the program, and secondary referrals 22
were accepted from health professionals, organisations and community members. 23
Eligibility was assessed at the time of referral or contact with local health districts 24
and based on anthropometric measures and a medical questionnaire completed by a 25
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parent/ carer, who also provided written consent for their child to participate in the 1
research. 2
A maximum variation sampling method based on the community weight 3
management program participant demographics and program group characteristics 4
will be used in the evaluation. In the sample of parents/ carers and children we will 5
aim to include; high and low attendance (</>50%) in the weight management 6
program, single child and multiple sibling families, participants from smaller program 7
groups (<six children) and larger program groups (>eight children). A variation of 8
ethnicity, culturally and linguistically diverse (CALD) and socioeconomic status (SES) 9
characteristics will also be included. 10
Second, participants in the evaluation shall be stakeholders who were involved in the 11
delivery of the RCT, including; public servants, policy makers, behavioural 12
specialists, program managers for local health districts, and community health 13
professionals. These shall be selected, beginning with core stakeholders who were 14
directly involved in the design and implementation of the RCT, and informed by the 15
research data collection as it progresses. 16
17
Design 18
Logic model 19
The logic model (Figure 1) shows the aspects most critical to the success of the 20
RCT, to guide this evaluation. The logic model shows the intended inputs and 21
activities involved in implementing the incentives-based intervention as well as the 22
intended outcomes and broader impacts 23
24
Levels of evaluation and how they relate to the Logic model 25
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To address each of the three aims, three levels of qualitative evaluation will be 1
conducted: (i) process, (ii) impact, and (iii) intervention deconstruction. The 2
evaluation plan is summarised in Table 1. 3
4
Table 1. Evaluation plan 5
Aim
Levels of evaluation and how they relate to Logic model
Evaluation component
Data source Timing of data collection
1. Identify what factors influenced implementation fidelity
Level: Process evaluation Relates to intended activities and outputs in the logic model
Content delivery (stakeholders) Content engagement (participants) Reach
Combination of: Stakeholder interviews Survey of parents/ carers Focus groups with parents/ carers Family interviews Decision logs, implementation plans and other project management documentation
Within two months after the six month follow-up health assessments of the RCT (estimated to commence Aug/ Sept 2016) The survey of parents/ carers was distributed and collected from all parents/ carers during the six month health assessments (May/ June 2016)
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2. Identify what factors influenced behaviour change and the broader impact on participants’ lives
Level: Impact evaluation Relates to intended outcomes and impacts in the logic model
The broader environment Key participant characteristics Program factors
Combination of: Focus groups with parents/ carers Family interviews
Within two months after the six month follow-up health assessments as part of the RCT (estimated to commence Aug/ Sept 2016)
3. Identify the active components of the intervention that influenced behaviour
Intervention deconstruction
Behaviour change intervention components
Transcripts generated from focus groups and interviews
On completion of aims 1 and 2 (estimated early 2017)
1
Aim 1. Process evaluation 2
The process evaluation will determine the degree the incentives-based intervention 3
was implemented as intended (implementation fidelity). The evaluation will document 4
factors influencing how the different components of the intervention were delivered 5
and received from the perspectives of those delivering and receiving the intervention, 6
and compare this with intended implementation by the trial Stakeholder Working 7
Group (see Acknowledgements). 8
9
The framework used to guide the design of the process evaluation was the 10
Normalisation Process Theory.[38] Normalisation Process Theory provides a 11
conceptual framework for understanding the processes by which interventions are 12
implemented and integrated into everyday practice. The model explores factors 13
involved in the dynamics between people delivering and receiving an intervention in 14
order to account for outcomes of the implementation process, and differences 15
between expected and observed outcomes in real settings. In implementing an 16
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intervention in a natural setting Normalisation Process Theory argues that people 1
need to continuously make sense of the work they are doing (coherence), engage 2
with it (cognitive participation), enact it (collective action), and reflect on it (reflective 3
monitoring). With an emphasis on exploring these concepts the process evaluation 4
will look at three evaluation components. These are: (i) content delivery, (ii) content 5
engagement, and (iii) reach, and are shown in Table 1. Content delivery refers to the 6
delivery and receipt of each individual input component of the intervention from the 7
perspective of those delivering the intervention. Content engagement refers to the 8
delivery and receipt of each component of the intervention from the perspective of 9
those receiving the intervention. Reach refers to the proportion of the intended target 10
audience who participated in the intervention, and the process evaluation will 11
specifically explore reasons expressed for discontinuing the program. 12
13
Information collected from stakeholders (those implementing the intervention) will 14
include perceptions on the roles and activities involved in the implementation of the 15
intervention, from initial discussions through to intervention design, set-up, project 16
management and facilitation. Perceptions on the acceptability, including integration 17
and disruption to the standard community program, benefits and impacts of the 18
intervention and suggestions for improvement will also be collected. 19
Information collected from participants (parents/ carers and children receiving the 20
intervention) will include perceptions on how specific components of the intervention 21
were understood and engaged with, and recounts of their experiences of interacting 22
with the intervention materials, other families and facilitators. Perceived benefits, 23
strengths/ weaknesses and suggested improvements will also be collected. 24
25
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Aim 2. Impact evaluation 1
The impact evaluation will determine the contextual factors that influenced trial 2
outcomes and broader impacts, and identify for whom the incentive scheme was 3
most and least effective in terms of having an effect during the community weight 4
management program and sustained impacts after the program. Investigations will 5
include the environmental and social context associated with participation in the 6
intervention, individual attitudes and beliefs about healthy living, and associated 7
barriers and enablers to adapting to new behaviours and forming new habits 8
9
The Realistic Evaluation model [39] was used to inform the design of the impact 10
evaluation and Table 1 outlines the three evaluation components the investigation 11
will focus on. These are: the broader environment, participant characteristics, and 12
program factors. The broader environment refers to other health activity, particularly 13
other interventions and healthy eating programs the family was involved in at the 14
time of the intervention, as well as barriers and enablers to participation and 15
engagement in the community weight management program associated with the 16
home environment and the families’ lifestyle. Participant characteristics were 17
identified at baseline in the trial and include; age, gender, single or separated family 18
status, single or multiple sibling family. This information will be used to recruit 19
participants for focus groups and family interviews (with the aim of including a mix of 20
characteristics), and will also be factored into analyses. Program factors to be 21
explored include; size of the community weight management program group, 22
regional or metro site location, venue type, and day the program sessions were held 23
(weekday or a weekend day), and will also be informed by the process evaluation. 24
25
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Information collected will draw from those receiving the intervention (children and 1
their parents/ carers), and include lifestyles, attitudes and health behaviours, 2
perceptions on what has changed in their lives since the program, habits retained, 3
and behaviours that have proven difficult to integrate into their lifestyles. Specific 4
impacts of the individual intervention components will be explored in depth. 5
All intended primary and secondary outcomes of the trial will be considered in the 6
investigation of contextual factors. The primary measure in the RCT was body mass 7
index at the end of the community weight management program (10 weeks) and at 8
six months. Secondary outcomes included: Waist circumference; nutrition and 9
physical activity behaviours and self-esteem (by survey) at the end of program (10 10
weeks) and at six months. Attendance rates during the program (completion of >75% 11
of sessions) was also measured in the trial. The evaluation will also compare 12
perceptions of the incentives scheme in relation to the outcomes in the absence of 13
the intervention (control group). This will help determine how the intervention 14
influenced outcomes, and whether the effects were intended. 15
16
Aim 3.Intervention deconstruction 17
The intervention deconstruction will explore and describe which specific components 18
of the incentives-based intervention were most impactful and why. The incentives 19
intervention was developed iteratively in 2014 drawing from a review of the relevant 20
literature, workshops, focus groups and field visits. Combined literature review and 21
advice from community program leaders highlighted the importance of incentivising 22
goals and activities (e.g. having healthier lunches) rather than outcomes (e.g. weight 23
loss) for greater impact on behaviour change.[40,11] For example, in a series of 24
RCTs across 203 elementary schools, it was reported that providing incentives for 25
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reading books was more effective than providing incentives for outcomes such as 1
scores on a test.[40] Community program leaders indicated during field research that 2
while goal setting as part of the program was usually specific, measureable, 3
achievable, relevant, and timely (SMART), it was likely to be of value to enhance the 4
goal setting process, including resetting/ stretching goals if they are achieved too 5
easily, and linking goal achievement to incentives. The importance of choosing the 6
appropriate size, type and timing of incentives was also highlighted as critical for 7
motivating change. For example, a study in children [26] found that a larger financial 8
reward (a US quarter rather than a nickel) combined with receiving it on the same 9
day as the behaviour was performed produced the largest behaviour change. The 10
key behavioural concepts that informed the design of the individual intervention 11
components (inputs in the logic model) are summarised below in Table 2. 12
13
The Behaviour Change Technique Taxonomy (BCTTv1) [41] will be used as a 14
framework for deconstructing the behaviour change intervention components used in 15
the trial. The purpose of this is threefold: (i) to optimise the robustness and 16
replication potential of the research by using a common language to recognise and 17
specify the components of the intervention that are changing behaviour (use of the 18
taxonomy supports the CONSORT guidelines for the reporting of behaviour change 19
interventions,[42] (ii) to facilitate translation of the interventions for the greatest effect 20
on child obesity outcomes by separating the active ingredients within the intervention 21
components and the conditions under which they are effective, from components 22
that may be less necessary and (iii) to understand more about any intervention 23
components that may be useful but were not sufficient in dose to produce an impact 24
on outcomes.[34] It will also be useful to refer to the full list of 93 items in the 25
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Behaviour Change Technique Taxonomy [41] in the analysis of how and why specific 1
components worked or didn’t work. The behaviour change technique mappings 2
shown below in Table 2 have been mapped in retrospect as a starting point to guide 3
analysis. For this exercise careful attention was paid to the coding definitions 4
specified in the Behaviour Change Technique Taxonomy,[41] and the “BCT 5
taxonomy” app was downloaded through Apple to guide coding. 6
7
Table 2. Behavioural concepts and corresponding behaviour change intervention 8
components, mapped to the Behaviour Change Technique Taxonomy. 9
*Corresponds with Inputs (material resources) and Activities in the logic model 10
Concept to illicit behaviour change
Behaviour change intervention component developed for the trial*
Mapped to the Behaviour Change Technique Taxonomy [41]
Incentivising behaviours and activities rather than outcomes is more effective for sustained behaviour change than rewarding outcomes [33,40,43]
Enhanced goal setting process including establishing a "big wish” (the overall outcome), then deciding on small achievable weekly goals which were re-set and stretched each week (with modified SMART goals handout)
Goals and Planning (1.4 action planning) Note 8.3 Habit formation and 8.7Graded tasks may also apply
Rewards scheme linked to weekly nutrition and exercise goal attainment
Reward and Threat (10.1 material reward (behaviour)
People are motivated to complete a goal when they can see their progress [44]
Group “Goals and Rewards Tracker”
Feedback and monitoring (2.5 monitoring of outcomes of behaviour without feedback)
Small and frequent rewards can increase task perseverance [44]
Low value weekly rewards
Reward and Threat (10.1 material reward (behaviour)
An implementation intention can help people achieve a goal [45-47)
Modified “Goals and Rewards Contract”(between parent/ carer and child)
Goals and Planning –(1.8 behavioural contract )
Lucky draw-style rewards may increase effectiveness of incentives [17,22,25]
Prize draw incentive six months after community weight management program
Reward and Threat –(anticipation of future reward – not categorised by the app used to code)
Text message prompts w SMS scheme linked to Feedback and Monitoring
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can improve health behaviours [48]
six month prize draw (10.4 social reward)
1
Data Sources 2
The evaluation will use a qualitative analysis, which will explore multiple groups of 3
people’s perspectives on the benefits, acceptability, and other ways in which 4
incentives could be used for behaviour change. Data collection will include a 5
combination of focus groups, family and stakeholder interviews, and a survey 6
(interview schedules and the survey are included as supplements to this paper). 7
Table 3 provides details of the data sources and their aims. 8
9
Table 3. Summary of data sources and their aims 10
Data source Scope Recruited by Aim 1.Survey of parents/ carers who participated in the community program
A 5-minute written survey of 10 questions with a mix of open-ended, single and multiple response questions. One per parent/ carer (control and treatment)
Distribution and collection at the six month health assessments of the trial
Focus: overall barriers and enablers to behaviour change, and recruitment Obtain top of mind feedback on core elements of the intervention, and invite families to consent to be contacted for a focus group or family interview
2. Focus groups with parents/ carers
4-6 groups, lasting 30-60mins, with 6-8 participants depending on thematic saturation
Brief survey. Selection will be based on quota specifications around key participant and group characteristics (see ‘Participants’)
Focus: process evaluation Explore experiences, perceptions and engagement in the specific intervention component
3. Family interviews with parents/ carers
10-20 interviews lasting 30-60mins, depending on
Brief survey. Selection will be based on quota
Focus: impact evaluation Gain insights into
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and their children who participated in the community program, and other family members (e.g. siblings)
thematic saturation specifications around key participant and group characteristics (see ‘Participants’)
the contextual factors influencing outcomes
4. Stakeholder interviews
10 individual or group interviews depending on thematic saturation
Phone calls made by GE. Stakeholders will be targeted according to quotas based on roles in the various design and implementation stages of the RCT
Focus: process evaluation Understand issues associated with the intended and actual delivery of the intervention
5.Project management materials
Decision logs, implementation plans and other project management documentation
Retracing project management activity, stored securely at the Department of Premier and Cabinet)
Collect additional insight into issues, mitigations, processes and learnings documented by the project team throughout the trial
1
The focus groups and interviews will follow a semi-structured approach, and 2
facilitation will be supported by bullet-pointed topic guides to facilitate natural 3
conversation between moderator and participants by emphasising topics, objectives 4
and flow. Each focus group and interview will be recorded and transcribed verbatim. 5
Participants will be made aware of this at the start of the group or interview and their 6
consent obtained. All discussions will be confidential. GE will conduct the focus 7
groups and interviews in a private room within a facility near to the participants’ 8
residence (such as a community centre) or place of work. A second researcher will 9
also be present in the room in an observatory capacity to take notes during the group 10
discussion. Refreshments and parking reimbursement will be provided for focus 11
group participants. To optimise attendance a $40 (e.g. a supermarket voucher) will 12
be offered to each family who participates in an interview. 13
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1
Data analysis and synthesis 2
Data analysis and synthesis will be based on the Grounded Theory approach.[49-51] 3
Qualitative data from focus groups, family and stakeholder interviews, and the 4
survey will be transcribed and systematically coded, drawing out the key points. 5
Similar codes will be grouped into concepts and categories based on emergent 6
themes. The coding process will begin with the first interview and be repeated for 7
each subsequent interview or focus group with the use of field notes, memos and 8
constant comparison to accumulate ideas about how concepts relate to each other. 9
For each transcript examples will be extracted that either confirm or contradict the 10
emerging themes. Once thematic saturation occurs, no further interviews and focus 11
groups will be necessary. Two researchers will conduct the analysis, and if at any 12
stage consensus cannot be reached, a third researcher will review those aspects. 13
NVivo software will be used to assist with qualitative data management. The overall 14
output will be a set of probability statements about the relationship between 15
concepts, or a set of conceptual hypotheses [50] about the barriers and enablers to 16
implementation of the incentives scheme, and its impact on the behaviour of 17
participants. 18
19
The analysis will be conducted in three waves, corresponding to the three levels of 20
evaluation in this research - the process, impact and behaviour change component 21
evaluations. Specifically, for the process evaluation the coding process will refer 22
back to the individual input and activity components in the logic model. Each focus 23
group and interview transcript will be scanned for themes relating to the delivery and 24
receipt of each component of the incentives scheme. Project management materials 25
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will also be reviewed and examples identified to support or contradict themes 1
emerging from the transcribed data. For the impact evaluation the coding process 2
will be related back to the intended outcomes and impacts of the intervention, as per 3
the logic model. Each focus group and interview transcript will be scanned for 4
themes associated with broader environmental influences on the effects of the 5
incentive scheme, and in relation to different participant characteristics and program 6
factors. The output will include typologies to describe for whom and how incentives 7
may impact behaviour. The intervention deconstruction will be guided by the 8
Behaviour Change Technique Taxonomy [41] as a basis for describing the active 9
intervention components and exploring whether the perceived impacts of the 10
intervention support or contradict the behavioural concepts underlying the design of 11
intervention. The specific mechanisms of the incentives-based behaviour change 12
scheme that lead to behaviour change may be associated with behavioural concepts 13
outside of those identified in the literature and influenced by unanticipated factors, 14
which the researchers will explore throughout the analysis. 15
The findings will be triangulated, drawing on the variety of data sources and 16
perspectives, and with comparison to the trial control group to determine whether the 17
trial outcomes can be attributed to the intervention. Issues and potential biases in the 18
design of the trial will be carefully factored in to interpretations. 19
20
Timing of data collection 21
The timing of the data collection is shown above in Table 1. Data will be collected at 22
two points: (i) during the six-month follow-up assessments in the RCT (which is 23
complete), (ii) one to two months after the six-month assessments. Conducting the 24
fieldwork close to the follow-up assessments will minimise corruption of the RCT as 25
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the evaluation data collection will prompt people to remember their experiences 1
during a pre-scheduled intervention point. Focus groups and stakeholder and family 2
interviews are estimated to commence in August 2016. 3
4
DISCUSSION 5
This paper details the protocol for a qualitative evaluation to be conducted shortly 6
following a RCT aimed at increasing behaviour change in overweight and obese 7
children participating in a community-based obesity program. The research aims to 8
address the challenges of public health interventions and provide information about 9
the barriers and enablers to the implementation of an incentives-based intervention 10
and its impact on health-related behaviour change in children. This research will 11
determine the relationships between intervention delivery, contextual factors 12
influencing outcomes, and the mechanisms of behaviour change, and provide 13
detailed information on the acceptability of the incentives-based scheme and its 14
potential as an obesity-reducing strategy in children in a range of contexts. It has 15
potential to add considerable value to the interpretation of the quantitative-based 16
RCT outcomes and inform future implementation and translation as a behaviour 17
change strategy for managing obesity in overweight children, should the 18
interventions be deemed acceptable. The knowledge will also advance the 19
development of further strategies for health-related behavior change in children, 20
supporting positive change in tackling the growing global problem of obesity. 21
22
DECLARATIONS 23
Ethics and dissemination 24
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This study will adhere to the National Health and Medical Research Council ethical 1
guidelines for human research. The study has been approved by the South West 2
Sydney Human Ethics Committee review body (HREC/14/LPOOL/480). Appropriate 3
site-specific approvals have been obtained from relevant research governance 4
offices. Consent was obtained from existing RCT participants during the trial to be 5
contacted for qualitative research. The findings of this study will be disseminated via 6
the usual scientific forums including peer-reviewed publications and presentations at 7
international conferences. The study will be administered by the George Institute for 8
Global Health, with the design and conduct overseen by a Steering Committee. 9
Unpublished data from the study such as anonymised transcripts and coded survey 10
dataset may be requested from the corresponding author at 11
[email protected]. Consent will be obtained from study participants for 12
transcripts prior to dissemination. 13
14
Competing interests 15
None known 16
17
Authors’ contributions 18
GE led the drafting of all sections of the article in consultation with all the co-authors. 19
JR/ GE led the application for funding for this work. All authors provided substantial 20
contribution to the concept and design of the evaluation, drafting the protocol paper 21
and reviewing critically for important intellectual content and final approval of the 22
version for publication. 23
24
Funding 25
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This research is funded in-kind provided by the George Institute for Global Health 1
and the Department for Premier and Cabinet. GE is funded by a PhD scholarship 2
through the George Institute for Global Health within the NHMRC program grant 3
ID1052555. JR is funded by a Career Development and Future Leader Fellowship 4
co-funded by the National Health and Medical Research Council and the National 5
Heart Foundation. AR is funded by an NHMRC Principal Research Fellowship 6
APP1124780. JR and AR are investigators on NHMRC program grant ID1052555. 7
8
Acknowledgements 9
This evaluation would not have been possible without the contributions of the RCT 10
investigator team and Working Group. Investigators and Working Group members 11
who are not co-authors on this paper, and their affiliates are listed below: 12
• Office of Preventive Health: Anita Cowlishaw; Santosh Kanal; Nicholas 13
Petrunoff 14
• Behavioural Insights Unit, Department of Premier and Cabinet: Shirley Dang 15
• Western Sydney LHD: Christine Newman; Michelle Nolan; Deborah Benson, 16
Kirsti Cunningham 17
• South Western Sydney LHD: Mandy Williams; Leah Choi; Kate Jesus; 18
Stephanie Baker 19
• South Eastern Sydney LHD: Myna Hua; Linda Trotter; Lisa Franco 20
• North Sydney LHD: Paul Klarenaar; Jonothan Noyes; Sakara Branson 21
• Hunter New England LHD: Karen Gillham; Dr John Wiggers; Silvia Ruano-22
McLerie 23
• Mid North Coast LHD: Ros Tockley; Margo Johnson 24
• Better Health Company; Madeline Freeman; Bec Thorp 25
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• The George Institute for Global Health; Sarah Eriksson; Caroline Wu 1
In addition we thank the Go4Fun program leaders, and representatives from our 2
funding partner organisations, including the Heart Foundation, who have contributed 3
to the development and implementation of the RCT. 4
5
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36. Sacher PM, Chadwick P, Wells JC et al. Assessing the acceptability and 1
feasibility of the MEND Programme in a small group of obese 7-11-year-old 2
children. J Hum Nutr Diet 2005;18:3–5. 3
37. Centres for Disease Control and Prevention, Division of Nutrition, Physical 4
Activity, and Obesity, Body Mass Index (BMI); 5
http://www.cdc.gov/healthyweight/assessing/bmi/. Accessed 22 Dec 2016. 6
38. May C, Finch T: Implementation, embedding, and integrating practices: an outline 7
of normalization theory. Sociology 2009;43(3):535-554. 8
39. Pawson RT, Tilley N. Realistic Evaluation. London: Sage;1997. 9
40. Fryer R. Financial Incentives and Student Achievement: Evidence from 10
Randomized Trials. Quarterly Journal of Economics 2011;126(4):1755-1798. 11
41. Michie S., Richardson M., Johnston M. et al. The Behavior Change Technique 12
Taxonomy (v1) of 93 Hierarchically Clustered Techniques: Building an 13
International Consensus for the Reporting of Behavior Change Interventions. 14
ann. behav. med. 2013; 46: 81. 15
42. Boutron I, Moher D, Altman DG, et al. Extending the CONSORT statement to 16
randomized trials of non-pharmacologic treatment: Explanation and 17
elaboration. Ann Intern Med. 2008;148:295-309. 18
43. Anderson P, Harrison O, Cooper C et al. Incentives for Health. J Health Comm 19
2011;16:107-33. 20
44. Kivetz R, Urminsky O, and Zheng Y. The Goal-Gradient Hypothesis Resurrected: 21
Purchase Acceleration, Illusionary Goal Progress, and Customer Retention. 22
Journal of Marketing Research 2006;43(1):39-58. 23
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45. Adriaanse MA, Vinkers CDW, De Ridder DTD, et al. Do implementation 1
intentions help to eat a healthy diet? A systematic review and meta-analysis of 2
the empirical evidence. Appetite 2011;56(1):183-193. 3
46. Gollwitzer PM, Sheeran P. Implementation intentions and goal achievement: A 4
meta-analysis of effects and processes. Advances in experimental social 5
psychology 2006;38:69-119. 6
47. Belanger- Gravel A, Godin G, Amireault S. A meta-analytic review of the effect of 7
implementation intentions on physical activity. Health Psychology Review 8
2013;7(1): 23-54. 9
48. Hallsworth M, Berry D, Sanders M, et al. Stating Appointment Costs in SMS 10
Reminders Reduces Missed Hospital Appointments: Findings from Two 11
Randomised Controlled Trials. PLoS ONE 2015;10(10):e0141461. 12
49. Glaser BG, Strauss AL. The discovery of grounded theory: strategies for 13
qualitative research. Chicago: Aldine; 1967. 14
50. Glaser BG. Theoretical Sensitivity: Advances in the methodology of Grounded 15
Theory. Sociology Press; 1978. 16
51. Glaser, B.G. Doing Grounded Theory - Issues and Discussions. Mill Valley, CA: 17
Sociology Press; 1998. 18
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Figure 1. Behavioural incentives intervention logic model
Figure 1.
346x210mm (300 x 300 DPI)
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Discussionguide_familyinterview_v105.08.15
DiscussionguideforfamilyinterviewDuration:60mins
1.Introduction 5mins
• Welcome,thankyoufortakingpart• ExplainwhoIamandtoday’spurpose:tounderstandyourthoughtsand
livessixmonthsonfromtheGo4Funprogramme.• Explaintherearenorightorwronganswers,nojudgment,theinterview
isstrictlyconfidential,itwillberecordedandtranscribedforresearchpurposes
• Signingandcollectionofconsentform.Tellmethreethingsaboutyourselves:
• Whatyouallliketodoinyoursparetime-theymightbedifferentthings!• Favouriteoridealholiday• Somethingthatreallybothersyou
PARTONE:Theirlivesandattitudes 35mins2.Theirlives (10mins)
• Howwouldyoudescribeyourlife?[Encourageadjectives:fun,busy,relaxed,stressful,enjoyable,revolvedaroundthekids,nofreetime]
• Whatwouldyouliketobedoingmoreof–onyourownandasafamily?• Whatwouldyouprefertobedoinglessof–onyourownandasafamily?• Howwouldyoudescribeyourhomeandlivingarea?
o Favouriteandleastfavouriteplaces–whatdoyoulikeabouttheseplaces?Howdoyoufeelthere?Whodoyougotherewith?
o Whatwouldyouchangeaboutwhereyoulive?• Howmuchtimedoyouspendasafamily?Whatmakesiteasierorharder
todothingstogether?• Dothekidsdoanyafterschoolorweekendactivities?Whatmakesit
easierorhardertodotheseactivities?• Howdoyoubalancework/schoollife,sociallife,familytime,hobbies,
studying,andallthedifferentpartsofyourlife?3.Attitudestowardhealthandhealthbehaviours (25mins)
• LETTHEKIDSSHOUTOUTFIRST:WhatcomestomindwhenIsay“health”(capturetheirlanguageandexploreassociations)
Objective:Determinethecontextualfactorsinfluencingtheinterventionoutcomesandbroaderimpactonparticipants’lives:
- Explorelifestyle- Explorewhathaschangedinthepastsixmonthssincetheprogramme- Observedynamicsbetweenfamilymembers
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• PERSONIFICATION:If“health”walkedintotheroomrightnowwhatwouldtheylooklike?
o Maleorfemale/ageo Whataretheywearing?Whatjobdotheydo(ifanadult),where
dotheylive?o Whatarethebestthingsabouttheirpersonality?o Andthenotsogoodthings?o Describetheirfamilyandfriendso Whatisyourrelationshiptothem?o Whatwouldtheysaytoyou?o Wouldyouliketobelikethisperson–why/whynot?
• Whatdoesitmeantobe“healthy”?[Promptemotional,social,spiritual,
intellectualaswellasphysicalhealth]o Whatarethebenefitsofbeinghealthy?o Arethereanycompromises?o Whatemotionscomewithbeinghealthy?
• Howabout“unhealthy?o Whataretheconsequencesofbeingunhealthy?o Inwhatcircumstancesdoyouthinksomeonebecomesunhealthy?
Arethereanybenefitsofbeingunhealthy?[E.g.yougettoeatchocolate]
o Whatemotionscomewithbeingunhealthy?
• Howeasyisittofitineatinghealthilyandkeepingactive?o Arethereanyshortcutstobeingactive?o Arethereanytipsandtrickstoeatinghealthily?
Theirdiets• How“healthy”wouldyousayyourdietsare?Whatdoyoubasethison?• Doyoutendtoeatthesamethingsasafamily?• Doyouevereattogether?Whatdeterminesthis?• Doyoupackaworklunch?• Howoftendoyoucookathome?Whodoesthecooking?• Wheredoyoubuyyourgroceries?Howoften?Whodoestheshopping
usually?• HowhasyourdietandeatinghabitschangedsincetheGo4Fun
programme?(ifatall)• Whathashelpedorgotteninthewayofthischange?• Howdoyoufeelabouthealthyeatingnow?
Theiractivitylevels• Howactiveareyouall?• Doyouthinkyouaremoreorlessactivethantheaveragefamilyofyour
ages?• HowhaveyouractivitylevelsorhobbieschangedsincetheGo4Fun
programme?• Howeasyhasitbeentomakethesechangesandsticktothem?
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• Whathashelpedorgottenintheway?• Howdoyoufeelaboutactivelivingnow?
PARTTWO:Specificimpactoftheinterventions 20mins4.Overallperceptions (10mins)
• LETTHEKIDSSHOUTOUTFIRST:WhatwordscometomindwhenyouthinkabouttheGo4Funprogramme?
• Thinkingbackoverthewholetenweekprogramme,whichsessionsstandouttoyoumost?
o Whatwerethebestbits?Whatdidyoulikeaboutit?o Andthenotsogoodbits?Whydoyousaythis?
• HowhaveyourliveschangedasaresultofGo4Fun?(ifatall)• Whathasbeenthebiggestbenefitoftheprogrammetoyou?• Whatareaofyourliveshasitimpactedthemost?[Promptemotional,
social,intellectual,spiritualandphysical]• Howhaveyourattitudestowardshealthyeatingbeenaffected?(ifatall)• Howhaveyourattitudestowardsexerciseandbeingactivebeeneffected
(ifatall)• Whatareyoudoingnowspecificallythatisdifferenttobeforeyou
participatedintheGo4Funprogramme?(ifanything)• Whichpartsoftheprogrammedoyouthinkledtothesechanges?• Howdoyoufeelsixmonthsonfromtheprogramme?
5.ImpactofSMARTgoalsettingandrewards (10mins)
• DoyourememberhowtosetaSMARTgoalnow?• Howhaveyoubeenfeelingaboutgoalsettinganddoinggoalssincethe
programmeended?• Howeasyhasitbeentofitthesix-monthgoalsintoyourlifesincethe
programme?• Whathashelpedorhinderedyou?• Howmuchdidtherewardshelptomotivateyouduringtheprogramme?• Havethetextmessagesinthelastsixmonthshelpedatall?Inwhatway?• Howhaveyoufoundcarryingonwiththegoalswithouttherewards?• Haveyoucarriedonwithgivingrewardsinthefamily?• Whichhaveyoufoundeasier/harder-thenutritiongoalsorexercise
goals?Whyisthis?• Whichbehaviourshavecontinuedthemostsincetheprogramme?• Whathashelpedyoukeepitup?• Whathasgottenintheway?• Whatelsewouldmakeiteasiertocarryonthesameactivitiesorhealthy
eating?Thankandclose
• Anythingelsetoadd?• WhathasbeenthebiggestimpactoftheGo4Funprogrammeonyour
lives?
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Discussionguide_parentfocusgroup_v105.08.15
DiscussionguideforparentfocusgroupDuration:60mins
1.Introduction 5mins
• Welcome,thankparticipantsfortakingpart• ExplainwhoIamandtoday’spurpose:tounderstandyourthoughtson
andexperiencesoftheGo4Funprogramme.• Explaintherearenorightorwronganswers,nojudgment,thefocus
groupisstrictlyconfidential,itwillberecordedandtranscribedforresearchpurposes
• Signingandcollectionofconsentform.
GroupIntroductions:Askthegrouptointroducethemselvesonebyoneandgivethreefactsaboutthemselves:
1. Whatyouliketodoinyoursparetime2. Favouriteoridealholiday3. Somethingthatreallybothersyou
PARTONE:Theirlivesandattitudes 15mins2.Theirlives (10mins)
• FLIPCHART:Howwouldwedescribeourlives?[Encourageadjectives:busy,relaxed,stressful,enjoyable,revolvedaroundthekids,nofreetime…]
• Whatwouldweliketobedoingmoreof?• Whatwouldweprefertobedoinglessof?• BRIEFLYGOROUNDGROUP&DRAWONFLIPCHART:Describewhata
typicaldaylookslikeforyou[Prompttimegetup,breakfastroutine,gettingreadyforschool,daytime/work,collectingkids,afterschool,snacks,afterschoolactivities/play/homework,dinner,kidsbed,adultseveningandbed…]
• Howdoesthisdiffertotheweekend?3.Attitudestowardhealth (5mins)
• FLIPCHART:Whatcomestomindwhenwethinkof“health”(capturetheirlanguageandexploreassociations)
• Howdowefeelabouthealth?• PERSONIFICATION:If“healthwalkedintotheroomrightnowwhat
wouldtheylooklike?o Maleorfemale/age
Overallobjective:Determinethedegreethegoalsandrewardsinterventionwasimplementedasintended:
- Explorehowwellspecificinterventioncomponentswerereceivedandengaged
- Exploreunderstanding,motivation,perceivedbenefits,strengths,andweaknessesoftheinterventions,andsuggestionsforimprovement
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o Whataretheywearing?Whatjobdotheydo(ifanadult),wheredotheylive?
o Whatarethebestthingsabouttheirpersonality?o Andthenotsogoodthings?o Describetheirfamilyandfriendso Whatisyourrelationshiptothem?o Whatwouldtheysaytoyoupersonally?o Wouldweliketobelikethisperson–why/whynot?
• Whatdoesitmeantobe“healthy”?• Howabout“unhealthy?Whataretheproblemswithbeingunhealthy?
PARTTWO:Perceptionsoftheinterventions 40mins4.Overallperceptions (10mins)
• FLIPCHART:WhatwordscometomindwhenwethinkoftheGo4Funprogramme?
• Thinkingbackoverthewholeten-weekprogramme,whichsessionsstandoutmost?
o Whatwerethebestbits?Whatdidwelikeaboutthem?o Andthenotsogoodbits?Whydoyousaythis?
• Howdidwefirsthearabouttheprogramme?o Howdidwegetinvolved?Whatwastheprocesslike?Whatwas
the‘sellingfactor’?• Howmanysessionsdidweeachattend?
o Whatkeptuscomingbackeachweek?o Whatgotinthewayofcoming?
• Whathasbeenthebiggestbenefitoftheprogramme?[Promptmakingfriends,losingweight,educationaboutfood,gettingfitter…]
• Whoexactlyhasbenefittedfromtheprogramme?• HowhaveourliveschangedasaresultofGo4Fun?(ifatall)• Wasthereanythingmissingfromtheprogramme?• Anythingwewouldchangeabouttheprogrammeifwecould?• Howdowefeelabouttheleaders?• Whatwasitlikebeingtogetherinagroup?
o Hasanyonesocialisedwithanyonefromthegroupduringorsincetheprogramme?
• WhatdowerememberaboutDPCresearcherscomingintohelp?• Whohavewetalkedtoabouttheprogramme?Whatdidwesayaboutit?• Whatwouldwesaytosomeonenowwhoisthinkingofjoiningthe
programmenextteam?5.SMARTgoalsettingandrewards (15mins)
• HowwelldidweunderstandtheSMARTgoalsetting?o Whatcouldhavemadeiteasier/moreenjoyable?o Howdidwefeelabouthavingthehandoutwiththeexample
SMARTgoalsontheback?–wasithelpful,annoying…wheredideveryonekeepit?Didweuseit?How/whendidweuseit?
o Howwelldidtheleaderexplainit?
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o Dowethinkthekidsunderstoodit/andengagedwithit?o Isitanimportantpartofthegoalsetting?o Whatquestionsdowestillhaveaboutit?
• Howdidwefeelaboutthegoalsettingpartoftheprogramme?[Prompt
easy/hard,boring/interesting…]o Dowestillfeelthiswaynow?o Howhelpfulwastheleader?o Howinvolveddidyoupersonallyget?o Whatelsewouldhavehelped?o Werethereanyothergoodornotsogoodthingsaboutthegoal
setting?
• Howdidwefeelabouttherewards?o Whichrewardsdidourkidslike?o Werethereanyweortheydidn’tlike?o Howdowefeelabouttherewardsbeinggivenoutforattendance?o Howmuchdidtherewardsmotivateourkidstocomebackto
Go4Funeachweek?o Howdowefeelabouttherewardsbeinggivenoutforachieving
thegoalseachweek?o HowmuchdidtheymotivatethefamilytocomebacktoGo4Fun?o Howmuchdidtheymotivateourkidstodothegoals?
6.Doingthegoals (10mins)
• Howeasyorhardwasittodothegoalseachweekduringtheprogramme?
o Howinvolvedwereweathomeinourkidsdoingthegoals?o Whatkindsofconversationsdidwehavewithourkids?o Whatwouldhavehelpeduswiththegoals?o Howoftendidtheleadercheckin?Weretheyhelpful?o Howoftendidwestretchourgoals?Didwerememberhowto
makethegoalsSMART?Werethekidsengagedwiththis?o Werethegoalstooeasy/toohard?o Howdowefeelthisallfitwiththerestoftheprogramme?o Dowefeelcompletingthegoalshashelpedourkidsinanyway?In
whatwayhavetheyhelpedornothelped?o Whatwasitlikeworkingtogetherwiththekidsonthegoals?
Describewhatitwaslikedoingthemeachweek–didwehavetoprompt,howdidothersiblingsfitin…
o Werethenutritionorexerciseeasiertodo?Explore.o FLIPCHART:Forwhatreasonswereweunabletodothegoals
sometimes?
• Howhavewefounddoingthegoalsoverthepastsixmonths?o Whathavebeenthebiggestobstacles?[Promptmotivation,
weather,cultural,lifestyleetc.]
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7.Thetextmessages (5mins)• Howdowefeelaboutthetextmessages?
o Havethekidsbeenseeingthem?o Howmotivatinghavetheybeen?[Exploremotivationfordoingthe
goalsandmaintainingattitude]o Howwelldidweunderstandwhatweneededtodo?o Howmotivatingwastheprizedrawattheend?[Explore
motivationfortextingbackanddoingthegoals]o Howmuchdidwediscussthetextsandgoalsasafamily?Who
normallypromptedtheseconservations?o Didweeverfeelinneedofmorehelp?Whatdidwedoaboutthis?o Whatwouldwechangeabouttheprocess?
Thankandclose
• Anythingelsetoadd?• GOAROUNDINDIVIDUALLY:Whatoneimprovementwouldyoumaketo
thegoalsettingandrewardspartoftheGo4Funprogramme?
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DiscussionguideforstakeholdersDuration:30-60mins
1.Introduction 5mins
• Explainaimofinterview:tounderstandyourthoughtsonthebehaviouralincentivestrialanditsimplementationintheGo4Funprogramme.
• Explainconfidentiality,recordingforresearchpurposes,sign/collectconsent.
• Tellmealittleaboutyourbackgroundandyourrolenow.Whatareyourfavourite/leastpreferredpartsofyourjob?
2.PerceptionsofandroleintheGo4Funprogramme 10mins
• WhatwordscometomindwhenyouthinkoftheGo4Funprogramme?• Whatarethemainbenefitsoftheprogramme?Towhom?• Whatarethemostimportantcomponentsoftheprogramme?• Inyourviewisanythingmissingfromtheprogrammecontent?• Whataretheweaknessesoftheprogramme?[promptpartswithlow
engagement,lowunderstanding,nutritioncontent,structure/flow,leadership,management…]
• DRAWIT:Whoisresponsibleforthemanagementoftheprogramme?[promptkeymanagers,thenpeopleatalllevels]–canyoudrawamanagementstructure,includingeveryoneinvolved?
• Howwellistheprogrammemanaged?• Whatarethestrengthsandweaknessesinthemanagementofthe
programme?• Whatisyourusualroleinmanagingtheprogramme?
3.Theirroleintheintervention 10mins
• Describeyourroleintheincentivesintervention• Atwhatpointdidyougetinvolved?Whichfurtherpointsthroughoutthe
trialwereyouinvolved?• Howdidyoufirsthearaboutthetrial?• Whatwereyourfirstthoughtsaboutthetrial?• Didyouhaveanyreservations?• Howdidyoucommunicatethese?• Howdidyouovercomethereservations,ordotheystillexist?• Whatotherissuesdidyouhaveatanypointinthetrial?• Howdidyouworkthroughthese?• Whodidyouworkwith?
4.Deliveringtheintervention 20mins
• Whatareyourthoughtsonthedeliveryoftheintervention?
Objective:Understandactivitiesandtheprocessesinvolvedintheimplementationofthebehaviouralincentivesintervention,frominitialdiscussionsthroughtointerventiondesign,setup,projectmanagementandfacilitation.Exploreperceptionsonacceptabilityoftheinterventionandsuggestionsforimprovement.
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• Describetheprocessesinvolvedasyouseethem• Howwouldyoudescribethecollaborationsinvolved?• Wereyouawareoforpersonallyinvolvedinanyconflictingviews
throughouttheimplementationoftheintervention?[Prompttheethicsprocess,designingthenewresources,replacingexistingresources,introducingthegoal-settingandrewardsschemeandworkingthroughthesewithfamilies,recordinggoals,standardisingattendanceincentives,selectingandprocuringtherewardsthemselves].
• Whowasinvolvedintheconflictingviews?• Tellmeaboutanydisruptionyoufeeltherewastothenormalprogramme
[explorespecificcomponents]• Whatdidyoufeelworkedespeciallywell?Whydoyouthinkthiswent
well?• Whatworkedlesswell?Tellmeaboutthemainproblemsandhowthey
wereovercome.• Areyouawareofanyproblemsexperiencedorfeedbackfromthe
participatingfamilies?Howwereyoumadeawareofthis?Wastherearesponse?
Specificcomponents
a) GoalsandRewardsGroupTrackerb) SMARTgoalsettingandstructuredrewardsc) Attendancerewardsd) Goalachievementrewardse) Sixmonthgoalsettingandtextmessages
• Howwelldoyoufeeleachcomponentwasintegratedintotheexisting
programme?• Howwelldidyouandtheleadersunderstanditandhowwellwasit
facilitated?• Whatwouldhaveimprovedtheprocess?
5.Perceptionsontheimpactoftheintervention 15mins
• Towhatextenddoyoufeeltheenhancedgoalsettingandrewardsschememotivatedfamiliestodothegoalsathome?
• Towhatextenddoyoufeeltherewards(attendanceorthoselinkedtogoals)motivatedfamiliestoattendtheprogramme?
• Whatroledoyoufeeltheprogrammeleaderplayedinmotivatingfamiliestoattendandachievegoals?
• Whatimpactdoyouthinktheinterventionhadforfamilies?• TowhatextenddoestheinterventionimprovetheGo4Funprogramme?• Towhatextentdoestheinterventionaddressweaknesseswiththe
existingprogramme?• Whatwouldyousuggesttoimprovetheintervention?Whatwouldyou
addorremove?Thankandclose-anythingelsetoadd?
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Survey_parents_v230.09.15
Briefsurveyforparents/guardiansWheredidyouattendGo4Fun?Q1.WhatthreewordscometomindwhenyouthinkofyourGo4Funexperience?(OE)1.2.3.Q2.Whichpartsoftheprogrammedidyougetthemostvaluefrom?(OE)Q3.Whatwerethebiggestobstaclestodoingthegoals?Tickanythatapply.(MR)a.Weather b.Culturalreasons c.Renovation,movinghouseorbeingonholiday d.Illness e.Lackofmotivation f.Goalswereunrealistic g.OtherWriteithere:Q4.HowwouldyouimprovetheGo4Funprogramme?(OE)Q5.DidyoureceiveweeklytextmessagesfromGo4Funoverthepastsixmonths?(SR)a.Yes–GotoQ6.b.No–GotoQ9
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Survey_parents_v230.09.15
Q6.Howmotivatingweretherewardsfordoingthegoalseachweek?(SR)a.Verymotivating b.Motivating c.Neithermotivatingnordemotivating d.Demotivating e.Verydemotivating Q7.HowhasthegoalsettingandrewardscomponentofGo4Funhelpedyourchildorchildrenliveahealthierlife?Tickanythatapply.(MR)a.Asafamilywehaveahealthierattitudetowardsfood b.Asafamilyweeatmorefruitandvegetables c.Ipersonallyhaveahealthierattitudetowardsfood d.Mychildorchildrenaremoreactivenow e.Ihaven’tnoticedachangeinmychild’sbehaviour f.Ihaven’tnoticedachangeinmyfamily’sbehaviour Q8.WouldyoubehappytoparticipateinafamilyintervieworfocusgroupaboutGo4Fun?Tickoneorbothifyou’dlikeandifyouprovideyourcontactdetailsGemmaEnrightwillcontactyousoontoarrangeatime.a.I’dliketoparticipateinafamilyinterview b.I’dliketoparticipateinafocusgroup Mycontactdetailsare:Name:_______________________________________________________________Email:______________________________________________________________Phone:______________________________________________________________c.Nothankyou. Q9.Anyothercomments?Feelfreetotellusanyotherthoughtsyouhaveabouttheprogramme!
Thankyousomuchfortakingthetimetocompletethesurvey!
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BMJ Open
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on August 28, 2020 by guest. P
rotected by copyright.http://bm
jopen.bmj.com
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MJ O
pen: first published as 10.1136/bmjopen-2016-012536 on 16 D
ecember 2016. D
ownloaded from