ANZCTR - Registration

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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

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

eating disorders

body image

Condition category

Condition code

Mental Health

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]

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]

Disordered eating cognitions will be measured using the Eating Disorder Examination - Questionnaire. This is a 22-item self-report measure.

Timepoint [1]

Baseline, post-program, 6-month follow-up and 12 month follow-up (primary time point).

Secondary outcome [1]

Disordered eating behaviours as assessed by 8-items from the self-report Project Eating Amongst Teens measure.

Timepoint [1]

Baseline, post-program, 6-month follow-up and 12 month follow-up

Secondary outcome [2]

Media internalisation will be measured using the Sociocultural Attitudes Towards Appearance Questionnaire-3 scale. This is a 9-item, self-report questionnaire.

Timepoint [2]

Baseline, post-program, 6-month follow-up and 12-month follow-up.

Secondary outcome [3]

Depressive symptoms will be measured using the 10-item Child Depression Inventory –Short Form, a self-report measure.

Timepoint [3]

Baseline, post-program, 6-month follow-up and 12-month follow-up.

Secondary outcome [4]

Weight-based teasing will be measured using the self-report McKnight Risk Factor Survey for Grades 6-12 (8-items).

Timepoint [4]

Baseline, post-program, 6-month follow-up and 12-month follow-up

Secondary outcome [5]

Screen time will be assessed using the 8-item Growing Up Today scale (self-report).

Timepoint [5]

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

Sex

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

7/05/2018

Date of last participant enrolment

Anticipated

Actual

1/06/2018

Date of last data collection

Anticipated

28/06/2019

Actual

Sample size

Target

912

Accrual to date

Final

996

Recruitment in Australia

Recruitment state(s)

SA,WA

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian Rotary Health

Address [1]

Australian Rotary Health
PO Box 3455, Parramatta NSW 2124

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Flinders University Social and Behavioural Research Ethics Committee

Ethics committee address [1]

Flinders University Social and Behavioural Research Ethics Committee
Flinders University
GPO Box 2100 | Adelaide SA 5001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/05/2017

Approval date [1]

11/07/2017

Ethics approval number [1]

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

Dr Simon Wilksch

Address

Senior Research Fellow
College of Education, Psychology & Social Work
Flinders University
GPO Box 2100
Adelaide, SA, 5001

Country

Australia

Phone

+61 8 8201 7996

Fax

simon.wilksch@flinders.edu.au

Contact person for public queries

Name

Simon Wilksch

Address

Senior Research Fellow
College of Education, Psychology & Social Work
Flinders University
GPO Box 2100
Adelaide, SA, 5001

Country

Australia

Phone

+61 8 8201 7996

Fax

simon.wilksch@flinders.edu.au

Contact person for scientific queries

Name

Simon Wilksch

Address

Senior Research Fellow
College of Education, Psychology & Social Work
Flinders University
GPO Box 2100
Adelaide, SA, 5001

Country

Australia

Phone

+61 8 8201 7996

Fax

simon.wilksch@flinders.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2202	Informed consent form					377675-(Uploaded-28-05-2019-15-46-21)-Study-related document.pdf
2203	Informed consent form					377675-(Uploaded-28-05-2019-15-46-40)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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