Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000545369
Ethics application status
Approved
Date submitted
14/10/2008
Date registered
28/10/2008
Date last updated
28/10/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can media literacy reduce eating disorder risk factors in young adolescents? A controlled evaluation.
Scientific title
School-based media literacy program for reducing eating disorder risk factors in young adolescents: A controlled evaluation
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating disorder risk factors (anorexia nervosa, bulimia nervosa, eating disorders not otherwise specified) 3827 0
Condition category
Condition code
Mental Health 4014 4014 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The media literacy program was an 8-lesson (50 minutes each) school-based program delivered by the primary researcher (SW, with the regular class teacher also present). Media literacy aims to target media internalisation (strong investment in societal ideals of size and appearance to the point that they become rigid, guiding principles), which has been prospectively identified as an eating disorder risk factor.

The program was informed by previous trials as well as a pilot evaluation. It was designed to be interactive (e.g., small group work, class discussions) as this approach has been found to have a self-esteem enhancing effect and to thus be more valuable than didactic delivery. The program was constructed around the key concepts of literacy, activism and advocacy. It was delivered at the rate of 2 lessons per week and thus took 4 weeks to complete.
Intervention code [1] 3549 0
Prevention
Comparator / control treatment
Control classes received their normal lessons from their usual class teacher (English, Study of Society and Science).
Control group
Active

Outcomes
Primary outcome [1] 4913 0
shape and weight concern (Eating Disorder Examination - Questionnaire, Fairburn & Beglin, 1994)
Timepoint [1] 4913 0
1. Baseline
2. Post-program (4 weeks after baseline)
3. 6-month follow-up
4. 30-month follow-up
Secondary outcome [1] 8297 0
In addition to the primary outcome, a further seven eating disorder risk factors were measured in questionnaire format:
dieting (Dutch Eating Behaviour Questionnaire - Restraint, Van Strien, Frijters, Bergers, & Defares, 1986);
body dissatisfaction (Eating Disorder Inventory, Garner, 1991);
media internalisation (Sociocultural Attitudes Towards Appearance Questionnaire-3, Thompson, van den Berg, Roehrig, Guarda, & Heinberg, 2004);
perceived sociocultural pressure to be thin (Perceived Sociocultural Pressure Scale, Stice, Ziemba, Margolis, & Flick, 1996);
feelings of ineffectiveness (Eating Disorder Inventory, Garner, 1991);
depression (Kovacs, 1992); and,
self-esteem (Rosenberg, 1965).
Timepoint [1] 8297 0
1. Baseline
2. Post-program (4 weeks after baseline)
3. 6-month follow-up
4. 30-month follow-up

Eligibility
Key inclusion criteria
Grade 8 students from 4 randomly selected secondary schools
Minimum age
12 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None (participants were intact school classes, meaning no students from each class was excluded)

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)
Schools were selected at random and invited to participate in the study. Approximately half of the Grade 8 classes from each school were randomly allocated to the media literacy condition, while the other half were randomly allocated to the control condition. Allocation was not concealed, however the researchers chose intact classes without prior knowledge of students or staff members from individual classes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
540
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4009 0
University
Name [1] 4009 0
Flinders University
Country [1] 4009 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
School of Psychology,
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country
Australia
Secondary sponsor category [1] 3635 0
University
Name [1] 3635 0
Flinders University
Address [1] 3635 0
School of Psychology,
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country [1] 3635 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6088 0
Flinders University Social and Behavioural Research Ethics Committee
Ethics committee address [1] 6088 0
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Ethics committee country [1] 6088 0
Australia
Date submitted for ethics approval [1] 6088 0
Approval date [1] 6088 0
27/02/2004
Ethics approval number [1] 6088 0
EC00194

Summary
Brief summary
The key objective of the current study was to address the shortcomings of previous universal eating disorder prevention programs by evaluating in a methodologically rigorous manner if a theoretically-informed prevention program (media literacy) can be effective in reducing eating disorder risk in a controlled trial with a universal, young-adolescent, mixed gender audience.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29035 0
Address 29035 0
Country 29035 0
Phone 29035 0
Fax 29035 0
Email 29035 0
Contact person for public queries
Name 12192 0
Dr Simon Wilksch
Address 12192 0
School of Psychology,
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 12192 0
New Zealand
Phone 12192 0
08 8201 2996
Fax 12192 0
08 8201 3877
Email 12192 0
[email protected]
Contact person for scientific queries
Name 3120 0
Dr Simon Wilksch
Address 3120 0
School of Psychology,
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 3120 0
Australia
Phone 3120 0
08 8201 2996
Fax 3120 0
08 8201 3877
Email 3120 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
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Documents added automatically
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