Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000495426
Ethics application status
Approved
Date submitted
24/09/2007
Date registered
27/09/2007
Date last updated
27/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can decreasing perfectionism impact on risk factors for eating disorders in adolescent females? A controlled comparison of perfectionism and media literacy programs.
Scientific title
A controlled comparison of school-based perfectionism and media literacy programs for reducing eating disorder risk factors in adolescent females.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating disorders (Anorexia Nervosa and Bulimia Nervosa). 2402 0
Condition category
Condition code
Mental Health 2505 2505 0 0
Eating disorders
Mental Health 2507 2507 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two interventions were developed, one targeting perfectionism and one targeting media internalisation. Both of these variables are prospectively identified eating disorder risk factors. Both programs were 8 school lessons (50 minutes per lesson) in duration, delivered at a rate of 2 lesson per week. The programs were delivered by two postgraduate clinical psychology students (i.e., one student taught each program), with the regular class teacher also present.

Both programs were designed to be interactive (e.g., small group work, class discussions) as this approach has been found to have a self-esteem enhancing effect (O'Dea & Abraham, 2000) and to thus be more valuable than didactic delivery (Stice & Shaw, 2004). In addition, collaboration took place between the researchers and class teachers for suggestions regarding content, teaching style and learning activities.

1. The program targeting perfectionism was developed from an existing text (Adderholdt & Goldberg, 1999) that focuses on differentiating between the pursuit of excellence and being perfect. Student activities involved identifying the pros and cons of perfectionism, learning to identify perfectionistic thinking styles, "reframing failure" (ie., making mistakes can have benefits), developing coping strategies to cope with perfectionistic tendencies and learning how to change unehlpful behaviours through a graded approach.

2. The program targeting media internalisation was constructed around the key concepts of literacy, activism and advocacy and was informed by previous media literacy trials (Eating Disorder Awareness & Prevention, 1999; Wade, Davidson, & O'Dea, 2003) and in particular, a pilot study of the individual lessons with Grade 8 mixed-gender students (Wilksch, Tiggemann & Wade, 2006). Specific student activities involved learning to identify and challenge stereotypes presented in the media, learning about digital manipulation techniques of magazine images, identifying positive/healthy and negative/unhealthy messages communicated in the meida, and pracitising communicating with the media to express individual opinions regarding advertising techniques.
Intervention code [1] 2124 0
Prevention
Comparator / control treatment
Control group received normal school lessons.
Control group
Active

Outcomes
Primary outcome [1] 3402 0
Examining if a significant change in the following eating disorder risk factors occurred relative to other condition or control group:
Perfectionism.
Media Internalisation.
Pressure to be thin.
Dieting.
Shape and weight concern.
Self-esteem.
Depression.
Timepoint [1] 3402 0
Baseline, post-program (4 weeks after baseline), 3-month follow-up.
Secondary outcome [1] 5657 0
Participants' ratings of program value and enjoyment.
Timepoint [1] 5657 0
This secondary outcome was assessed in questionnaire format, immediately upon completion of the 8-lesson program.

Eligibility
Key inclusion criteria
Year 10 students at 2 randomly selected secondary schools.
Minimum age
14 Years
Maximum age
16 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None (pariticpants were intact school classes).

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. 3 classes from each school were randomly allocated to the perfectionism, media literacy and control groups, respectively. Allocation was not concealed, however the researchers chose intact classes without prior knowledge of students or staff member 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
9/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2645 0
University
Name [1] 2645 0
Flinders University
Country [1] 2645 0
Australia
Primary sponsor type
University
Name
Simon Wilksch
Address
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 2394 0
University
Name [1] 2394 0
Tracey Wade
Address [1] 2394 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country [1] 2394 0
Australia
Other collaborator category [1] 52 0
University
Name [1] 52 0
Mitch Durbridge
Address [1] 52 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country [1] 52 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4571 0
Flinders University Social And Behavioural Research Ethics Committee
Ethics committee address [1] 4571 0
Ethics committee country [1] 4571 0
Australia
Date submitted for ethics approval [1] 4571 0
Approval date [1] 4571 0
27/02/2004
Ethics approval number [1] 4571 0
EC00194

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28067 0
Address 28067 0
Country 28067 0
Phone 28067 0
Fax 28067 0
Email 28067 0
Contact person for public queries
Name 11224 0
Simon Wilksch
Address 11224 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 11224 0
Australia
Phone 11224 0
+61 8 82012996
Fax 11224 0
Email 11224 0
[email protected]
Contact person for scientific queries
Name 2152 0
Simon Wilksch
Address 2152 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 2152 0
Australia
Phone 2152 0
+61 8 82012996
Fax 2152 0
Email 2152 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.