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Trial registered on ANZCTR


Registration number
ACTRN12619000851167
Ethics application status
Approved
Date submitted
28/05/2019
Date registered
17/06/2019
Date last updated
17/06/2019
Date data sharing statement initially provided
17/06/2019
Date results information initially provided
17/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of an efficacious school-based eating disorder risk reduction program: A comparison of 2, 4 and 8 lessons
Scientific title
A randomised controlled trial of an efficacious school-based eating disorder risk reduction program: A comparison of 2, 4 and 8 lessons
Secondary ID [1] 298355 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eating disorders 313012 0
body image 313013 0
Condition category
Condition code
Mental Health 311518 311518 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Media Smart (MS) is a school-based program for girls and boys in Grade 7 and 8. The full program is 8 X 50 minute lessons. Given the constraints on school lesson time, this trial will evaluate how a 2- and 4- lesson version compares to the 8-lesson version that has been evaluated in previous research. The lessons will be taught by postgraduate psychology students, under the supervision of Dr Wilksch.

The standard 8-lesson version runs for a total of 400 minutes (2 X 50 minute lessons per week for 4 weeks). The 4-lesson version runs for a total of 200 minutes (2 X 50 minute lessons for 2 weeks). The 2-lesson version runs for a total of 100 minutes (2 X 50 minute lessons in 1 week).

The program includes interactive lesson content such as small group work, class discussions and watching of educational videos and PowerPoint presentations (made especially for the program). Students learn to question some of the messages they see in both traditional media (print, TV) and social media through interactive activities that educate about airbrushing and other techniques of image manipulation, stereotypes, peer pressure and identifying personal values. Adherence will be monitored through class attendance logs.

Within each school all 4 conditions will be represented (i.e.., MS-8 lessons, MS-4 lessons, MS-2 lessons, and controls). This will be done by all classes in one year level (e.g., Year 7 in School A) being allocated to the respective intervention conditions and all classes in the other year level (Year 8 in school A) being allocated to controls. In school B, this process is reversed (i.e., Year 8 is the intervention year level and Year 7 is the control year level). This randomisation will be completed using computer software.
Intervention code [1] 314597 0
Prevention
Comparator / control treatment
Control group will be classes who receive their usual school lessons plus a 1-page handout on tips for positive body image. This will be given to control classes when the intervention classes start their MS program. These tips for positive body image are not a standard reference that is publicly available.
Control group
Active

Outcomes
Primary outcome [1] 320219 0
Disordered eating cognitions will be measured using the Eating Disorder Examination - Questionnaire. This is a 22-item self-report measure.
Timepoint [1] 320219 0
Baseline, post-program, 6-month follow-up and 12 month follow-up (primary time point).
Secondary outcome [1] 370910 0
Disordered eating behaviours as assessed by 8-items from the self-report Project Eating Amongst Teens measure.
Timepoint [1] 370910 0
Baseline, post-program, 6-month follow-up and 12 month follow-up
Secondary outcome [2] 370911 0
Media internalisation will be measured using the Sociocultural Attitudes Towards Appearance Questionnaire-3 scale. This is a 9-item, self-report questionnaire.
Timepoint [2] 370911 0
Baseline, post-program, 6-month follow-up and 12-month follow-up.
Secondary outcome [3] 370912 0
Depressive symptoms will be measured using the 10-item Child Depression Inventory –Short Form, a self-report measure.
Timepoint [3] 370912 0
Baseline, post-program, 6-month follow-up and 12-month follow-up.
Secondary outcome [4] 370913 0
Weight-based teasing will be measured using the self-report McKnight Risk Factor Survey for Grades 6-12 (8-items).
Timepoint [4] 370913 0
Baseline, post-program, 6-month follow-up and 12-month follow-up
Secondary outcome [5] 370914 0
Screen time will be assessed using the 8-item Growing Up Today scale (self-report).
Timepoint [5] 370914 0
Baseline, post-program, 6-month follow-up and 12-month follow-up.

Eligibility
Key inclusion criteria
Any student in Grade 7 or 8 in participating schools will be eligible to participate. Up to 10 schools will be invited to participate based on previous participation in similar school-based research or having expressed an interest to the research group for assistance with body image education.
Minimum age
12 Years
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All students in the relevant grades of participating schools (Grade 7 or 8) will be eligible to participate. No exclusion criteria exists beyond the student or parent not providing 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)
Computer randomisation will be used, thus the researchers will not be involved in this process
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Within each school all 4 conditions will be represented (i.e.., MS-8 lessons, MS-4 lessons, MS-2 lessons, and controls). This will be done by all classes in one year level (e.g., Year 7 in School A) being allocated to the respective intervention conditions and all classes in the other year level (Year 8 in school A) being allocated to controls. In school B, this process is reversed (i.e., Year 8 is the intervention year level and Year 7 is the control year level).

This process is to ensure that demographic and other possible confounds are evenly represented across conditions.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary analyses of comparison between groups on changes in disordered eating will be based upon linear mixed-effects models (LMM) with random intercepts. Models will include fixed effects for group (MS-2, MS-4, MS-8, control), time (post-program, 6-month follow-up and 12-month follow-up) and gender (girls, boys), as well as interaction effects. Baseline scores will be used as a covariate and the model will adjust for the effect of clustering at a class level. Between group effect sizes and 95% confidence intervals will inform the relative effectiveness of the different versions of MS. Secondary analyses will be conducted with all continuous variables using LMM analyses as described above. Finally, to explore clinical significance, logistic regression analyses will be used to examine differences in binary outcomes (e.g., new cases of disordered eating behaviours at study endpoint).

Recruitment
Recruitment status
Active, not 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)
SA,WA

Funding & Sponsors
Funding source category [1] 302893 0
Charities/Societies/Foundations
Name [1] 302893 0
Australian Rotary Health
Address [1] 302893 0
Australian Rotary Health
PO Box 3455, Parramatta NSW 2124
Country [1] 302893 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Dr Simon Wilksch
College of Education, Psychology & Social Work
Flinders University
GPO Box 2100
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 302847 0
None
Name [1] 302847 0
Address [1] 302847 0
Country [1] 302847 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303467 0
Flinders University Social and Behavioural Research Ethics Committee
Ethics committee address [1] 303467 0
Flinders University Social and Behavioural Research Ethics Committee
Flinders University
GPO Box 2100 | Adelaide SA 5001
Ethics committee country [1] 303467 0
Australia
Date submitted for ethics approval [1] 303467 0
01/05/2017
Approval date [1] 303467 0
11/07/2017
Ethics approval number [1] 303467 0
7674

Summary
Brief summary
Media Smart (MS) is an 8-lesson school-based program that was developed by Dr Wilksch and Prof Wade and has been evaluated in a systematic program of research with over 2,000 participants. MS is now considered the leading ED risk reduction program worldwide for school-based, universal settings (i.e., given to all students regardless of risk status rather than selecting those at high-risk of an ED). However, many schools find 8 lessons difficult to timetable within the busy school program and given competing demands.

Therefore the overall aim is to conduct an RCT to assess the efficacy of MS when it is delivered in shortened formats, namely a 2- and 4-lesson version, compared to the full 8-lesson program. The study design will include school class randomisation to: MS–2 lessons (MS-2); MS–4 lessons (MS-4); the full 8-lesson MS program (MS-8) and control group (normal school lessons with provision of a 1-page tip sheet on improving body image). Consistent with previous RCTs, MS will be delivered by trainee psychologists who will receive 5-hours of training in the program. Students will complete measures at baseline, post-program, 6- and 12-month follow-up. Measures will assess disordered eating and ED risk factors.

This research is important in assisting with dissemination of the program given greater uptake is likely with a shorter curriculum. The rationale is not to replace MS-8 but to provide schools with informed, evidence-based alternatives for shorter versions that can better fit into the school program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93758 0
Dr Simon Wilksch
Address 93758 0
Senior Research Fellow
College of Education, Psychology & Social Work
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 93758 0
Australia
Phone 93758 0
+61 8 8201 7996
Fax 93758 0
Email 93758 0
simon.wilksch@flinders.edu.au
Contact person for public queries
Name 93759 0
Dr Simon Wilksch
Address 93759 0
Senior Research Fellow
College of Education, Psychology & Social Work
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 93759 0
Australia
Phone 93759 0
+61 8 8201 7996
Fax 93759 0
Email 93759 0
simon.wilksch@flinders.edu.au
Contact person for scientific queries
Name 93760 0
Dr Simon Wilksch
Address 93760 0
Senior Research Fellow
College of Education, Psychology & Social Work
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 93760 0
Australia
Phone 93760 0
+61 8 8201 7996
Fax 93760 0
Email 93760 0
simon.wilksch@flinders.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
This has not been applied for or approved by the Ethics Committee.
What supporting documents are/will be available?
Informed consent form
How or where can supporting documents be obtained?
Type [1] 2202 0
Informed consent form
Citation [1] 2202 0
Link [1] 2202 0
Email [1] 2202 0
Other [1] 2202 0
Type [2] 2203 0
Informed consent form
Citation [2] 2203 0
Link [2] 2203 0
Email [2] 2203 0
Other [2] 2203 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary