Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000558527
Ethics application status
Approved
Date submitted
6/05/2015
Date registered
29/05/2015
Date last updated
7/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of a behavioural incentive scheme in children: a new approach to address an expanding problem.
Scientific title
The effectiveness of a community weight management program with a behavioural incentive scheme compared to participation in a standard community weight management program in overweight children on relative weight loss and behaviour change.
Secondary ID [1] 286650 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 294978 0
Obesity 294979 0
Condition category
Condition code
Public Health 295245 295245 0 0
Health promotion/education
Cardiovascular 295246 295246 0 0
Other cardiovascular diseases
Diet and Nutrition 295427 295427 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children in the intervention sites will be participating in a community weight management programme (namely Go4Fun)and will also be eligible to receive incentives for reaching certain levels of attendance and for goal attainment. An overview of the incentives being as follows;
1. Attendance: children are incentivised for attending program sessions. Children will receive a skipping rope for attending 80% of program sessions (8 sessions) and a frisbee for 100% attendance (10 sessions).
2. Goal attainment: children are incentivised for achieving mutually-agreed (child/leader/family) goals before the next session. Specific, achievable and measureable goals will be and examples include ‘I will go for a family walk at least once a week for the next month’ or ‘I will not drink soft drink on school days for the next month.’ Once the goals are achieved children are eligible to receive agreed incentives as follows; a vegetable slicer once two goals are achieved, a $10 Rebel voucher once four goals are achieved and a height adjustable tennis set (Totem Tennis) once six goals are achieved.

The existing Go4Fun program is a community-based, multidisciplinary family-focused program that targets weight-related behaviours and self-esteem of children aged 7 to 13 years who are overweight or obese. The program includes 10 x one hour-sessions per week during school terms. Sessions are group-based and comprise face-to-face physical activity sessions and education (behaviour change, nutrition, self-esteem) provided by trained health professionals. In line with current evidence about the importance of family engagement, both parent/guardian and the child attend the weekly sessions. To monitor adherence, weekly attendance records and participant diaries (physical activity, diet and goal achievement) are kept.
Intervention code [1] 291791 0
Behaviour
Intervention code [2] 291792 0
Lifestyle
Intervention code [3] 291793 0
Prevention
Comparator / control treatment
Children in the control sites will participate in the standard community weight management programme (namely Go4Fun) without the structured behaviour incentives. As described above, the standard program consists of weekly group sessions for 10 weeks during the school term.

The Go4Fun program is a community-based, multidisciplinary family-focused program that targets weight-related behaviours and self-esteem of children aged 7 to 13 years who are overweight or obese. The program includes 10 x one hour-sessions per week during school terms. Sessions are group-based and comprise face-to-face physical activity sessions and education (behaviour change, nutrition, self-esteem) provided by trained health professionals. In line with current evidence about the importance of family engagement, both parent/guardian and the child attend the weekly sessions. To monitor adherence, weekly attendance records and participant diaries (physical activity, diet and goal achievement) are kept.
Control group
Active

Outcomes
Primary outcome [1] 294994 0
Mean change in BMI z score
Timepoint [1] 294994 0
18 months after intervention commencement
Secondary outcome [1] 314523 0
Mean change in mean waist circumference z score
Timepoint [1] 314523 0
18 months after intervention commencement
Secondary outcome [2] 314524 0
Mean change in Body Mass Index
Timepoint [2] 314524 0
18 months after intervention commencement
Secondary outcome [3] 314525 0
Difference in rate of attendance at programme sessions between intervention and control sites . Assessed by review of attendance and program records.
Timepoint [3] 314525 0
10 weeks (end of programme) after commencement of programme.
Secondary outcome [4] 314549 0
Difference in mean rate of nutrition goal attainment between intervention and control groups. Assessed by review of program records in combination with participant diaries.
Timepoint [4] 314549 0
10 weeks (end of programme) after commencement of programme.
Secondary outcome [5] 314550 0
Difference in mean rate of physical activity goal attainment between intervention and control groups. Assessed by review of program records in combination with participant diaries.
Timepoint [5] 314550 0
10 weeks (end of programme) after commencement of programme.

Eligibility
Key inclusion criteria
Sites
To be eligible to participate in the trial, sites must meet the following criteria;
1. Participating in standard Go4Fun program in 2015;
2. 2014 attendance average of at least 20 children per program per term and;

Participants
To be eligible to participate in this trial, children must meet the following criteria;
i. Aged 7-13 years with no co-morbidities;
ii. Have a body mass index > 85th percentile for their age and gender (according to AIHW classification of overweight/obesity in children);
iii. Be enrolled in and meet the general criteria to participate in the Go4Fun program at one of the sites participating in this study which includes having a parent or adult carer able to accompany them to each session and;
Minimum age
7 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Sites
1. Not willing to participate in a trial and adhere to standardised procedures for duration of the trial.

Participants
1. Parent/guardian not willing to provide written and informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible sites will be randomised to either deliver the intervention (standard Go4Fun + incentives) or control (standard Go4Fun) program for 10 weeks. For site recruitment, all Go4Fun programs across NSW were invited to participate, 22 agreed and have secured ethical approval. Based on prior process evaluation work16 and from prior attendance records the recruited sites are likely to enrol an average of 25 children per site per term (~550 children per term). Given we intend to recruit across 2 terms (total 1100) and having recruited 214 children to date, our target of 570 children across 22 sites is highly feasible in terms of program delivery and participant capacity. Local program leaders will assess eligibility, obtain informed consent and conduct baseline study visits and research assistants will conduct the blinded follow-up assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was conducted using a computer-generated sequence (1:1) managed by the research team based at The George Institute and independent of any program leader or LHD. Clusters were stratified according to local health district to ensure equal representation across groups within each LHD.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Cluster randomised controlled trial.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A formal statistical analysis plan has been developed Analysis will be conducted at the individual level and will follow the intention-to-treat principle. The control and intervention groups will be compared on baseline characteristics using independent t-tests for continuous variables or chi-square tests for categorical variables. For the primary outcome, the mean difference in BMI z score at 12 months between control and intervention groups will be analysed after adjusting for the baseline characteristics using a generalised estimating equation (GEE) regression model. For the secondary outcomes, with continuous dependent variables GEE regression models will be used and for categorical dependent variables GEE logistic regression models will be used. These models will account for the between cluster variance and will be adjusted for baseline characteristics. All analyses will be undertaken using SAS 9.4 for Windows (SAS Institute Inc. Cary, NC, USA) and statistical significance will be set at P < 0.05.

Sample size: Intra-class correlation was calculated based on preliminary data (214 individuals) across the recruited 22 sites and was found to be 0.16 for BMI z score. To detect a between-group difference of 0.24 (+/- 0.43) in BMI z score (based on outcome data from a previous Australian randomised controlled trial examining 12 month weight loss outcomes in children), 23 participants from each of the 22 sites (11 intervention, 11 control) are required to achieve 80% power based on an alpha of 0.05. To account for 10% drop-out our target sample size is 570 children across 22 sites.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/02/2015
Actual
27/01/2015
Date of last participant enrolment
Anticipated
31/07/2015
Actual
2/05/2015
Date of last data collection
Anticipated
Actual
29/01/2017
Sample size
Target
570
Accrual to date
Final
512
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291230 0
Other Collaborative groups
Name [1] 291230 0
The George Institute for Global Health
Country [1] 291230 0
Australia
Funding source category [2] 291345 0
Government body
Name [2] 291345 0
Behavioural Incentives Unit, Office of Preventive Health, NSW Ministry of Health.
Country [2] 291345 0
Australia
Primary sponsor type
Other
Name
The George Institute for Global Health
Address
Level 10, King George V Building, Missenden Road, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 289904 0
Government body
Name [1] 289904 0
Behavioural Insights Unit, Office of Preventive Health, NSW Ministry of Health.
Address [1] 289904 0
Level 9, 52 Martin Place, Sydney NSW 2000.
Country [1] 289904 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292788 0
Sydney South Western LHD Research and Ethics Office
Ethics committee address [1] 292788 0
Ethics committee country [1] 292788 0
Australia
Date submitted for ethics approval [1] 292788 0
Approval date [1] 292788 0
12/12/2014
Ethics approval number [1] 292788 0
HREC/13/LPOOL/157

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57022 0
A/Prof Julie Redfern
Address 57022 0
Department of General Practice, Acacia House
The University at Westmead Hospital, PO Box 154 Westmead NSW 2154
Country 57022 0
Australia
Phone 57022 0
+61 (02) 8890 9214
Fax 57022 0
Email 57022 0
[email protected]
Contact person for public queries
Name 57023 0
Julie Redfern
Address 57023 0
Department of General Practice, Acacia House
The University at Westmead Hospital, PO Box 154 Westmead NSW 2154
Country 57023 0
Australia
Phone 57023 0
+61 (02) 8890 9214
Fax 57023 0
Email 57023 0
[email protected]
Contact person for scientific queries
Name 57024 0
Julie Redfern
Address 57024 0
Department of General Practice, Acacia House
The University at Westmead Hospital, PO Box 154 Westmead NSW 2154
Country 57024 0
Australia
Phone 57024 0
+61 (02) 8890 9214
Fax 57024 0
Email 57024 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Not yet public - will be presented at ESC in Aug 2... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluating factors influencing the delivery and outcomes of an incentive-based behaviour change strategy targeting child obesity: Protocol for a qualitative process and impact evaluation.2016https://dx.doi.org/10.1136/bmjopen-2016-012536
N.B. These documents automatically identified may not have been verified by the study sponsor.