Effectiveness of a Dissonance-Based Eating Disorder Prevention Program (The Body Project II)
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | April 21, 2008 | ||||||||
| Last Updated Date | April 24, 2013 | ||||||||
| Start Date ICMJE | March 2005 | ||||||||
| Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Eating Disorder Diagnostic Interview [ Time Frame: Measured at baseline, post-treatment, Month 6, and Years 1 and 2 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00663754 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Ideal-Body Stereotype Scale-Revised, Satisfaction and Dissatisfaction with Body Parts Scale, Dutch Restrained Eating Scale, Positive Affect and Negative Affect Scale-Revised, and Beliefs About Appearance Scale [ Time Frame: Measured at baseline, post-treatment, Month 6, and Years 1 and 2 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effectiveness of a Dissonance-Based Eating Disorder Prevention Program (The Body Project II) | ||||||||
| Official Title ICMJE | Eating Disorder Prevention Program Effectiveness Trial | ||||||||
| Brief Summary | This study will evaluate the effectiveness of dissonance-based eating disorder prevention programs in reducing body dissatisfaction among young women with body image concerns. |
||||||||
| Detailed Description | It is estimated that up to 80% of young adult women in the United States are dissatisfied with their appearance, particularly their weight. Young women's perception of the ideal body type is influenced by many factors, including peers, parents, and the media. Body dissatisfaction is associated with an increased risk of depression and eating disorders, making programs to reduce body image issues in young women important. Programs that target eating disorder prevention through promoting healthy behaviors and critiquing the thin ideal may be an effective means of increasing body satisfaction among young women. Particularly, a dissonance-based eating disorder prevention program that assesses the thin ideal through verbal, written, and behavioral exercises may be the best means of addressing body image concerns. This study will evaluate the effectiveness of dissonance-based eating disorder prevention programs in reducing body dissatisfaction among young women with body image concerns. Participation in this study will last 2 years and will involve both parent and daughter participants. Study participation for parent participants will include three 15-minute interviews conducted at baseline and Years 1 and 2. The interviews will focus on their daughters' social adjustment, performance in school, relationships with others, hobbies, and related topics. Daughter participants will still be allowed to partake in the study even if their parents do not complete all three interviews. All potential daughter participants will first complete a 20-minute interview regarding their eating habits and mental health. Eligible participants will then be assigned to one of three programs designed to improve body image satisfaction:
Participants in all programs will complete brief surveys and interviews about their attitudes and behaviors at baseline, at treatment completion, and at three other points during the 2 years from baseline. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Prevention |
||||||||
| Condition ICMJE | Eating Disorders | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 306 | ||||||||
| Completion Date | October 2012 | ||||||||
| Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Female | ||||||||
| Ages | 14 Years to 18 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 | NCT00663754 | ||||||||
| Other Study ID Numbers ICMJE | R01 MH070699, R01MH070699, DSIR 84-CTP | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Oregon Research Institute | ||||||||
| Study Sponsor ICMJE | Oregon Research Institute | ||||||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Oregon Research Institute | ||||||||
| Verification Date | April 2013 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||