Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000606886
Ethics application status
Approved
Date submitted
5/06/2012
Date registered
6/06/2012
Date last updated
6/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
School-based eating disorder prevention: A pilot effectiveness trial of teacher-delivered Media Smart
Scientific title
School-based eating disorder prevention: A pilot effectiveness trial of teacher-delivered Media Smart
Secondary ID [1] 280621 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eating disorders 286632 0
Condition category
Condition code
Mental Health 286915 286915 0 0
Eating disorders
Public Health 286931 286931 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Media Smart is an 8-lesson school-based program that aims to develop student skills in media literacy. Each lesson is of 50 minutes duration and is delivered at the rate of 2 lessons per week, thus taking 4 weeks in total. The lessons involve a range of interactive learning activities aimed at promoting media literacy, including before and after examples of airbrushing, investigation of stereotypical presentations of men and women in the media and students writing a letter to an advertising company to express concerns about the use of unhealthy advertising messages. The program will be delivered by teachers who have attended a 90-minute workshop in delivery of Media Smart.
Intervention code [1] 285020 0
Prevention
Comparator / control treatment
Usual school classes
Control group
Active

Outcomes
Primary outcome [1] 287272 0
Shape Concern and Weight Concern subscales (12 items) from the Eating Disorder Examination Questionnaire (EDE-Q; Fairburn & Beglin, 1994)
Timepoint [1] 287272 0
Baseline, post-program, 6-month follow-up
Secondary outcome [1] 297802 0
Dieting: Dutch Eating Behaviour Questionnaire ? Restraint Scales (10 items:Van Strien, Frijters, Bergers, & Defares, 1986)
Timepoint [1] 297802 0
Baseline, post-program, 6-month follow-up
Secondary outcome [2] 297822 0
Body dissatisfaction: Eating Disorder Inventory - Body Dissatisfaction (10 items: Garner, Olmstead, & Polivy, 1983)
Timepoint [2] 297822 0
Baseline, post-program, 6-month follow-up
Secondary outcome [3] 297823 0
Media internalisation: Sociocultural Attitudes Towards Appearance Questionnaire-3, (9 items: Thompson et al., 2004)
Timepoint [3] 297823 0
Baseline, post-program, 6-month follow-up
Secondary outcome [4] 297824 0
Ineffectiveness: Eating Disorder Inventory - Feelings of Ineffectiveness (10 items: Garner et al., 1983)
Timepoint [4] 297824 0
Baseline, post-program, 6-month follow-up
Secondary outcome [5] 297825 0
Self-esteem: Rosenberg Self-Esteem Scale (10 items: Rosenberg, 1965)
Timepoint [5] 297825 0
Baseline, post-program, 6-month follow-up
Secondary outcome [6] 297826 0
Weight-related peer teasing: McKnight Risk Factor Survey (8 items: Shisslak et al., 1999)
Timepoint [6] 297826 0
Baseline, post-program, 6-month follow-up

Eligibility
Key inclusion criteria
Year 7 school students
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
School classes are allocated to either Media Smart or control group by the toss of a coin
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation done at the class level, as above
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
1/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5388 0
5000

Funding & Sponsors
Funding source category [1] 285381 0
Self funded/Unfunded
Name [1] 285381 0
nil
Country [1] 285381 0
Primary sponsor type
Individual
Name
Dr Simon Wilksch
Address
School of Psychology
Flinders University
GPO Box 2100
Adelaide, SA, 5000
Country
Australia
Secondary sponsor category [1] 284239 0
None
Name [1] 284239 0
Address [1] 284239 0
Country [1] 284239 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287398 0
Flinders University Social and Behavioural Research Ethics Committee
Ethics committee address [1] 287398 0
Flinders University
GPO Box 2100
Adelaide, SA, 5000
Ethics committee country [1] 287398 0
Australia
Date submitted for ethics approval [1] 287398 0
Approval date [1] 287398 0
16/02/2010
Ethics approval number [1] 287398 0
4718

Summary
Brief summary
This study aims to pilot how well a previously successful school-based eating disorder prevention program works when delivered by teachers rather than health professionals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34271 0
Address 34271 0
Country 34271 0
Phone 34271 0
Fax 34271 0
Email 34271 0
Contact person for public queries
Name 17518 0
Dr Simon Wilksch
Address 17518 0
School of Psychology
Flinders Unviersity
GPO Box 2100
Adelaide, SA, 5000
Country 17518 0
Australia
Phone 17518 0
+61 08 8201 7996
Fax 17518 0
+61 08 8201 3877
Email 17518 0
[email protected]
Contact person for scientific queries
Name 8446 0
Dr Simon Wilksch
Address 8446 0
School of Psychology
Flinders Unviersity
GPO Box 2100
Adelaide, SA, 5000
Country 8446 0
Australia
Phone 8446 0
+61 08 8201 7996
Fax 8446 0
+61 08 8201 3877
Email 8446 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.