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Trial registered on ANZCTR


Registration number
ACTRN12621001762842
Ethics application status
Approved
Date submitted
11/11/2021
Date registered
23/12/2021
Date last updated
17/04/2024
Date data sharing statement initially provided
23/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial to evaluate the online delivery of the Better Health Program for children aged 7-13 years who have overweight or obesity in Victoria
Scientific title
A randomised control trial to evaluate the online delivery of the Better Health Program for children aged 7-13 years who have overweight or obesity in Victoria
Secondary ID [1] 305701 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood obesity 324173 0
Condition category
Condition code
Diet and Nutrition 321647 321647 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The online Better Health Program is a 10-week family-based program aimed to promote healthy behaviour changes in children aged 7-13 years, with overweight or obesity. The program consists of:
a. 10 interactive modules (1 module released per week to participants, each requiring approximately 30 minutes to complete), with pre-recorded multimedia presentation, games, and summary/recap questions. The modules provide evidence-based information and activities on/related to healthy eating, physical activity and behaviour change. The modules also include suggested targets for participants to meet related to the information presented in each module. To monitor/confirm participation/engagement in the program, the program includes weekly health coaching sessions where coaches would check in on the participant’s progress and address queries. Better Health Company team members/administrators are also able to retrieve information on the fraction of the modules each participant has completed via their education platform.
b. weekly health coaching sessions (expected to last approximately 30 minutes per appointment) conducted over the phone by a Better Health Company health coach. The coaches would check in on the participant’s progress and address queries related to the week’s completed module, including asking participants if they have met the suggested targets. If targets have been satisfied, health coaches would award participants with a token (the program includes a token system where participants may exchange their tokens for prizes at program completion).
c. questionnaires-measurements, medical history, physical activity, eating habits, parent survey, child survey, feedback (requiring approximately 30 minutes to complete; completed at the start and/or end of the program-post 10 weeks)
Intervention code [1] 322089 0
Lifestyle
Intervention code [2] 322090 0
Behaviour
Intervention code [3] 322425 0
Treatment: Other
Comparator / control treatment
This study will use a waitlisted control group. Participants allocated to the control group will commence the online Better Health Program the following school term.
Control group
Active

Outcomes
Primary outcome [1] 329420 0
Change in BMI z-score, derived from change in weight/weight z-score and height/height z-score measurements, from baseline to 10 weeks.
-Participants will self-report their weight and height in study-specific surveys administered at baseline, immediately post-program completion (10 weeks) and/or post-control period (10 weeks), 6 months and 12 months post-program completion.
-Participants will also be provided with written instructions and resources to complete measurements.
Timepoint [1] 329420 0
Baseline to post-10 weeks
Secondary outcome [1] 402533 0
Participants' (child, parent/legal guardian) experiences completing the online Better Health Program, explored through the administration of semi-structured interviews (narrative enquiry) over the phone or via Zoom video conferencing. The parent(s)/legal guardian(s) will be interviewed together with their child(ren), if possible, and then without them thereafter.
Timepoint [1] 402533 0
Interviews will be conducted at 3-months post-program completion
Secondary outcome [2] 404117 0
Physical activity/change in physical activity
-Assessed using the Youth Activity Profile (YAP) and existing Better Health Company physical activity survey (administered online, sent to participants via email and REDCap).
Timepoint [2] 404117 0
Baseline, immediately post-program completion (10 weeks) and/or post-control period (10 weeks), 6- & 12- months post-program completion
Secondary outcome [3] 404118 0
Quality of life/change in quality of life
-Assessed using the Pediatric Quality of life (PedsQL) survey (administered online, sent to participants via email and REDCap).
Timepoint [3] 404118 0
Baseline, immediately post-program completion (10 weeks) and/or post-control period (10 weeks), 6- & 12- months post-program completion
Secondary outcome [4] 421898 0
Waist circumference/change in waist circumference
-Participants will measure and self-report their waist circumference in study-specific surveys administered at baseline, immediately post-program completion (10 weeks) and/or post-control period (10 weeks), 6- & 12- months post-program completion.
-Participants will also be provided with written instructions and resources to complete measurement.
Timepoint [4] 421898 0
Baseline, immediately post-program completion (10 weeks) and/or post-control period (10 weeks), 6- & 12- months post-program completion
Secondary outcome [5] 421899 0
Dietary intake/change in dietary intake
-Assessed using the Australian Eating Survey and existing Better Health Company eating habits survey (administered online, sent to participants via email and REDCap)
Timepoint [5] 421899 0
Baseline, immediately post-program completion (10 weeks) and/or post-control period (10 weeks), 6- & 12- months post-program completion

Eligibility
Key inclusion criteria
To be enrolled in this study, participants must meet all of the following criteria:
• Classified as overweight or obese (BMI =85th percentile; CDC classification)
• Aged 7-13 years (inclusive)
• Are generally healthy, defined as an absence of clinical or comorbid conditions that would require medical clearance, to participate. Children with a learning or behavioural disability, that does not impact on their ability to engage in the program, will be eligible to participate
• Living in Victoria
• Have at least one parent/guardian who will accompany and support program uptake and engagement
• Parents can provide informed consent
Minimum age
7 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if:
• they are engaging in other (structured/referred) weight management programs/will not be discontinuing the program during study time period
• A language barrier exists and participants are unable to participate in the program which is delivered in English or provide informed consent
• They lack access to a device to access online resources and complete program modules/activities
• They have a sibling who is completing or already completed the program/study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation (1:1 ratio) will be used to increase the likelihood of equal numbers in each group. Research Randomizer will be used to complete the randomisation schedule (https://www.randomizer.org/).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Based on findings from previous evaluations of similar programs, sample size was calculated to detect a change in BMI z-score of -0.14 (0.15) between the intervention and control group (effect size = 0.6), at 5% significance and 80% power. A 30% attrition was also accounted for. This study therefore aims to recruit n=118 participants (n=59 in intervention and control group respectively).

Quantitative data will be analysed with SPSS software (IBM Corp. Released 2016. IBM SPSS Statistics for Windows, Version 24.0. Armonk, NY: IBM Corp). For all analysis, a p-value of <0.05 will be considered statistically significant. An independent t-test will be used to compare the difference in the mean change in BMI z-score between groups from baseline to 10 weeks. Independent t-tests will also be used to compare the differences in the quantitative outcome measures (e.g. BMI, waist circumference, quality of life, dietary intake, physical activity) between groups from baseline to 10 weeks. A 2 x 2 mixed ANOVA will be conducted to investigate the impact of the program (between factor: web-based program vs. control) on BMI z-score from baseline to 10 weeks (within factor). Mixed model ANOVAs will also investigate the impact of the program on the quantitative secondary outcome measures from baseline to 10 weeks. The impact of being waitlisted will be explored to determine whether receiving the program following 10 weeks of waiting will differ on quantitative outcome measures from immediately receiving the program over time. If being waitlisted does not have an impact on the quantitative outcome measures, a one-way repeated ANOVA will be used to assess the effect size of the program on quantitative outcome measures overtime. Independent t-tests may also be used to compare the differences in the mean changes in quantitative outcome measures between groups or compare the mean differences in quantitative outcome measures for all participants at immediately pre-program (baseline or post-10 weeks waitlisted period) and post-program completion.

Qualitative data will be analysed using an inductive coding approach and reflexive thematic analysis.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
21/02/2022
Actual
4/04/2022
Date of last participant enrolment
Anticipated
2/07/2023
Actual
10/07/2023
Date of last data collection
Anticipated
23/12/2024
Actual
Sample size
Target
118
Accrual to date
Final
148
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310061 0
Other Collaborative groups
Name [1] 310061 0
Better Health Company
Country [1] 310061 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Better Health Company
Address
20 - 24 Bond St, Abbotsford, Victoria, 3067
Country
Australia
Secondary sponsor category [1] 311112 0
None
Name [1] 311112 0
Address [1] 311112 0
Country [1] 311112 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309752 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 309752 0
Ethics committee country [1] 309752 0
Australia
Date submitted for ethics approval [1] 309752 0
26/10/2021
Approval date [1] 309752 0
20/12/2021
Ethics approval number [1] 309752 0
30472

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

Contacts
Principal investigator
Name 115270 0
Dr Zoe Davidson
Address 115270 0
Nutrition Dietetics and Food
Level 1, 264 Ferntree Gully Road
Notting Hill, VIC 3168
Country 115270 0
Australia
Phone 115270 0
+61 3 9902 4263
Fax 115270 0
Email 115270 0
zoe.davidson@monash.edu
Contact person for public queries
Name 115271 0
Diana Zhu
Address 115271 0
Nutrition Dietetics and Food
Level 1, 264 Ferntree Gully Road
Notting Hill, VIC 3168
Country 115271 0
Australia
Phone 115271 0
+61 4 2391 4947
Fax 115271 0
Email 115271 0
diana.zhu@monash.edu
Contact person for scientific queries
Name 115272 0
Diana Zhu
Address 115272 0
Nutrition Dietetics and Food
Level 1, 264 Ferntree Gully Road
Notting Hill, VIC 3168
Country 115272 0
Australia
Phone 115272 0
+61 4 2391 4947
Fax 115272 0
Email 115272 0
diana.zhu@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Some raw data (survey responses, interviews) require synthesis in order to be meaningful, therefore such raw data will not be made publicly available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13998Study protocolZhu D, Dordevic AL, Gibson S, Davidson ZE. Evaluating a 10-Week Family-Focused E-Health Healthy Lifestyle Program for School-Aged Children with Overweight or Obesity: A Randomized Controlled Trial Study Protocol. Nutrients. 2023; 15(13):2909https://www.mdpi.com/2072-6643/15/13/2909diana.zhu@monash.edu
13999Informed consent form  diana.zhu@monash.edu
14000Ethical approval  diana.zhu@monash.edu



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluating a 10-Week Family-Focused E-Health Healthy Lifestyle Program for School-Aged Children with Overweight or Obesity: A Randomized Controlled Trial Study Protocol.2023https://dx.doi.org/10.3390/nu15132909
N.B. These documents automatically identified may not have been verified by the study sponsor.