Eating Disorder Prevention Programs
| Tracking Information | |
|---|---|
| First Received Date ICMJE | July 24, 2002 |
| Last Updated Date | December 26, 2007 |
| Start Date ICMJE | February 2001 |
| Primary Completion Date | May 2007 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Eating Disorder Diagnostic Interview [ Time Frame: 1 year ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT00042185 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
The Ideal-Body Stereotype Scale-Revised, Satisfaction and Dissatisfaction with Body Parts Scale, Positive Affect and Negative Affect Scale-Revised [ Time Frame: 1 year ] [ Designated as safety issue: No ] |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Eating Disorder Prevention Programs |
| Official Title ICMJE | Austin Body Acceptance Study |
| Brief Summary | This study evaluated 2 eating disorder prevention programs designed to increase body satisfaction among adolescent females with body image concerns. |
| Detailed Description | Adolescent girls with body dissatisfaction (N=481; SD=1.4) were randomized to a dissonance-based thin-ideal internalization reduction program, healthy weight control program, expressive-writing control condition, or assessment-only control condition. Dissonance participants showed significantly greater decreases in thin-ideal internalization, body dissatisfaction, negative affect, eating disorder symptoms, and psychosocial impairment, and lower risk for eating pathology onset through 2-3 year follow-up than assessment-only controls. Dissonance participants showed greater decreases in thin-ideal internalization, body dissatisfaction, and psychosocial impairment than expressive-writing controls. Healthy weight participants showed greater decreases in thin-ideal internalization, body dissatisfaction, negative affect, eating disorder symptoms, and psychosocial impairment, less increases in weight, and lower risk for eating pathology and obesity onset through 2-3 year follow-up than assessment-only controls. Healthy weight participants showed greater decreases in thin-ideal internalization and weight than expressive writing controls. Dissonance participants showed a 60% reduction in risk for eating pathology onset and healthy weight participants showed a 61% reduction in risk for eating pathology onset and a 55% reduction in risk for obesity onset relative to assessment-only controls through 3-year follow-up, implying that the effects are clinically important and enduring. |
| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Condition ICMJE | Eating Disorders |
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 450 |
| Completion Date | May 2007 |
| Primary Completion Date | May 2007 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion criteria:
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| Gender | Female |
| Ages | 14 Years to 19 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT00042185 |
| Other Study ID Numbers ICMJE | R01 MH61957, DSIR 84-CTP |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Not Provided |
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | National Institute of Mental Health (NIMH) |
| Verification Date | December 2007 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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