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Trial registered on ANZCTR


Registration number
ACTRN12618000330246
Ethics application status
Approved
Date submitted
5/02/2018
Date registered
6/03/2018
Date last updated
19/02/2019
Date data sharing statement initially provided
19/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing obesity and promoting healthy body image in Australian secondary schools
Scientific title
Preventing obesity and promoting healthy body image in Australian secondary schools: a web-based system tailored to individual needs
Secondary ID [1] 292813 0
Nil
Universal Trial Number (UTN)
U1111-1200-9784
Trial acronym
SHINE (Supporting Healthy Image, Nutrition and Exercise)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity prevention 304630 0
Nutrition 304631 0
Physical activity 304632 0
Body image 304633 0
Condition category
Condition code
Diet and Nutrition 303950 303950 0 0
Obesity
Mental Health 303952 303952 0 0
Eating disorders
Public Health 303953 303953 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will develop and test a universal online education program about healthy nutrition and physical activity (SHINE) for adolescents that is designed to be part of the Year 7 health curriculum in 40 secondary schools across metropolitan Melbourne. The program will dynamically tailor content to provide additional advice for the targeted/selected young people with weight and shape concerns who are at risk of developing disordered eating behaviours and attitudes. It will also provide specific guidance for those who are overweight or obese, where intervention is required. Using machine learning predictive models to deliver individually customised advice, SHINE provides core health messages and, where indicated, additional information to optimise intervention engagement and efficacy. The program is tailored to increase the potential to improve body image and weight-related problems; improve nutrition and physical activity; help prevent the development or progression of obesity and thereby decrease the associated morbidities in later life. Twenty schools will be randomly selected to receive the intervention, and all students will complete the program as part of the usual Health and Physical Education (HPE) class. Trained Research Assistants will take participants' body measures (height, weight and body composition) and facilitate the delivery of an online questionnaire to participants at baseline, post-program, 12, 24 and 36 months post-program commencement. The 8 week, online SHINE program will be delivered during usual HPE classes by the class teacher who has received training on the SHINE program. Booster sessions will be delivered during one HPE class period when participants are in Year 8, 9 and 10. These sessions will consist of participants completing online food and activity logs as well as reviewing the key messages of the SHINE program and collecting body measures by trained Research Assistants. Two-weeks post-booster session, participants will again complete the online food and activity logs during usual HPE class with their HPE class teacher. Upon receipt of participant data (completion of weekly food and activity logs), the program will deliver individually tailored automated messages that cover progress, motivation and problem solving immediately to participants by email or text to encourage ongoing adherence to behavioural goals and to address barriers.

To monitor adherence to the intervention, students will navigate through core/compulsory topics at their own choosing however, progression to additional/targeted topics will be blocked until all core topics have been completed. The software for the program has been written to ensure only the core topics are initially visible, with further topics revealed after completion of all core topics. Additional adherence monitoring will be carried out by research staff who will conduct weekly spot checks of the participant database.
Intervention code [1] 299064 0
Early detection / Screening
Intervention code [2] 300524 0
Lifestyle
Intervention code [3] 300525 0
Prevention
Comparator / control treatment
A total of 20 secondary schools from metropolitan Melbourne will be randomised into the control arm of the study. As per the intervention arm, all Year 7 students from participating control schools will complete an online questionnaire and have their body measures taken by a trained Research Assistant during their usual HPE class. These measures will be taken at baseline, and again at 9 weeks, 12 months, 24 months- and 36 months post-baseline, Control participants will not receive the SHINE program and will continue with their usual HPE curriculum during class. However, schools originally allocated into the control arm of study will be offered the SHINE program two years post-baseline timepoint to avoid intervention contamination from the original control group participants.
Control group
Active

Outcomes
Primary outcome [1] 304281 0
Rates of overweight and obesity will be compared between the intervention and control groups by using digital scales and a bioelectric impedance analyser.
Timepoint [1] 304281 0
The primary outcome will be assessed at five timepoints - baseline, and again at 9 weeks, 12 months, 24 months and 36 months (primary timepoint) post-baseline.
Primary outcome [2] 304282 0
BMI z-scores will be compared between the intervention and control groups, which will be measured by digital scales and a rigid stadiometer.
Timepoint [2] 304282 0
The second primary outcome will be assessed at five timepoints - baseline, and again at 9 weeks, 12 months, 24 months and 36 months (primary timepoint) post-baseline.
Primary outcome [3] 304283 0
Weight and shape concerns will be compared between the intervention and control groups using a study-specific online questionnaire.
Timepoint [3] 304283 0
The third primary outcome will be assessed at five timepoints - baseline, and again at 9 weeks, 12 months, 24 months and 36 months (primary timepoint) post-baseline.
Secondary outcome [1] 341500 0
Levels of physical activity will be compared between the intervention and control groups using a study-specific online questionnaire and program.
Timepoint [1] 341500 0
Outcome will be assessed at baseline, 9 weeks, 12 months, 24 months and 36 months (secondary timepoint) post-baseline.
Secondary outcome [2] 341501 0
Rates of sedentary behaviour will be compared between the intervention and control groups using a study-specific online questionnaire and program.
Timepoint [2] 341501 0
Outcome will be assessed at baseline, 9 weeks, 12 months, 24 months and 36 months (secondary timepoint) post-baseline.
Secondary outcome [3] 343923 0
Dietary intake quality will be compared between the intervention and control groups using a study-specific online questionnaire and program.
Timepoint [3] 343923 0
Outcome will be assessed at baseline, 9 weeks, 12 months, 24 months and 36 months (secondary timepoint) post-baseline.
Secondary outcome [4] 343924 0
Assessment of body fat percentage will be compared between the intervention and control groups using a bioelectric impedance analyser.
Timepoint [4] 343924 0
The outcome will be measured at baseline, 9 weeks, 12 months, 24 months and 36 months (secondary timepoint) post-baseline.
Secondary outcome [5] 343925 0
Rates of depressive symptoms will be compared between the intervention and control groups using a study-specific online questionnaire.
Timepoint [5] 343925 0
Outcome will be measure at baseline, 9 weeks, 12 months, 24 months and 36 months (secondary timepoint) post-baseline.
Secondary outcome [6] 343926 0
Quality of life will be compared between the intervention and control groups using a study-specific online questionnaire.
Timepoint [6] 343926 0
Outcome will be assessed at baseline, 9 weeks, 12 months, 24 months and 36 months (secondary timepoint) post-baseline.
Secondary outcome [7] 343929 0
The cost-effectiveness of the online, obesity prevention program will be examined using quality adjusted life years (QALY).
Timepoint [7] 343929 0
The outcome will be assessed at baseline, 9 weeks, 12 months, 24 months and 36 months (secondary timepoint) post-baseline.

Eligibility
Key inclusion criteria
Secondary schools in metropolitan Melbourne as well as Victorian regional schools within a two hour drive from the CBD, with total Year 7 student enrolments of at least 40.
Minimum age
11 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students with poor to nil English literacy skills.

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)
Allocation to a study arm will be determined by the allocation schedule created by study's statistician. Once allocation has been made, schools will be informed of their allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Stratified allocation will be used for single sex schools. All other schools will be randomised using computer sequence generation.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
For this study, assuming a 33% prevalence of overweight and obesity in the control group at 36-months and similar correlation among students within classes, 1830 students in each arm provides power to detect a 6% reduction in prevalence of overweight or obese students in the intervention group at 36-months with 80% power (a = 5%, 2-sided) after allowing for clustering of students in classes (design effect of 2). Assuming 80% of the parents and students consent at baseline and a 20% dropout rate over the three years of follow-up, we would need to approach 2860 students for each arm of the study to retain a sample of 1830 students in each arm at 36 months.
We will conduct intent-to-treat analyses on our post-program outcome measures at 36 months using a multilevel modelling framework, to allow for the clustering of adolescents in classrooms and schools. Logistic regression models will be used to analyse the binary outcomes of overweight and obesity and body dissatisfaction, initially estimating the effect of the intervention unadjusted and then adjusted for baseline measures of the outcome, demographic and other potential confounding variables. Linear regression models will be used to analyse the standardised BMI z-scores for the students who were overweight or obese at baseline, to assess the effect of the intervention post-program. To investigate if the intervention effect changes over time, multilevel models allowing for a further level of clustering, the repeated outcome measures within students, will be used to analyse the outcomes post-program and at 12-, 24- and 36-months. If appropriate, multiple imputation will be used to handle missing data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 18764 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 297442 0
Government body
Name [1] 297442 0
NHMRC, Project Grant #1122840
Address [1] 297442 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 297442 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway
Burwood Vic 3125
Country
Australia
Secondary sponsor category [1] 297745 0
None
Name [1] 297745 0
Address [1] 297745 0
Country [1] 297745 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298551 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 298551 0
221 Burwood Highway
Burwood Vic 3125
Ethics committee country [1] 298551 0
Australia
Date submitted for ethics approval [1] 298551 0
Approval date [1] 298551 0
24/11/2017
Ethics approval number [1] 298551 0
2017-269
Ethics committee name [2] 302702 0
Victorian Department of Education and Training
Ethics committee address [2] 302702 0
2 Treasury Place
East Melbourne Vic 3002
Ethics committee country [2] 302702 0
Australia
Date submitted for ethics approval [2] 302702 0
13/12/2017
Approval date [2] 302702 0
18/05/2018
Ethics approval number [2] 302702 0
2018_003630

Summary
Brief summary
This study will develop and test a new program called SHINE, and builds on a significant body of work from our successful team of international collaborators. SHINE will deliver universal education about healthy nutrition and physical activity for all adolescents. At the same time, it will dynamically tailor content to provide additional advice for the targeted/selected young people with weight and shape concerns who are at risk of developing disordered eating behaviours and attitudes. It will also provide specific guidance for those who are overweight or obese, where intervention is indicated. Using machine learning predictive models to deliver individually customised advice, SHINE provides core health messages and, where indicated, additional information to optimise intervention engagement and efficacy. The program is tailored to increase the potential to improve body image and weight-related problems; improve nutrition and physical activity; help prevent the development/progression of obesity; and thereby decrease the associated morbidities in later life. The effectiveness of SHINE will be compared with the usual health curriculum.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2415 2415 0 0

Contacts
Principal investigator
Name 77434 0
Prof Jo Williams
Address 77434 0
Deakin University, Burwood Campus
Building BC
221 Burwood Highway
Burwood Vic 3125
Country 77434 0
Australia
Phone 77434 0
+61 3 9251 7203
Fax 77434 0
Email 77434 0
jo.williams@deakin.edu.au
Contact person for public queries
Name 77435 0
Ms Lisa McGivern
Address 77435 0
Deakin University, Burwood Campus
Building BC
221 Burwood Highway
Burwood Vic 3125
Country 77435 0
Australia
Phone 77435 0
+61 3 9246 8603
Fax 77435 0
Email 77435 0
lisa.mcgivern@deakin.edu.au
Contact person for scientific queries
Name 77436 0
Prof Jo Williams
Address 77436 0
Deakin University, Burwood Campus
Building BC
221 Burwood Highway
Burwood Vic 3125
Country 77436 0
Australia
Phone 77436 0
+61 3 9251 7203
Fax 77436 0
Email 77436 0
jo.williams@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In order to protect individual participants privacy, we will not be making IPD available. A decision has yet to be made whether the de-identified data of all participants involved in the study will be made available.
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable