Eating Disorders Prevention: An Effectiveness Trial for At-Risk College Students
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Purpose
This three-site effectiveness trial will test whether a brief dissonance-based eating disorder prevention program produces intervention effects when college counselors, psychologists, and nurses are responsible for participant recruitment, screening, and intervention delivery under ecologically valid conditions.
| Condition | Intervention |
|---|---|
|
Eating Disorders Obesity |
Behavioral: Body Project |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Eating Disorders Prevention: An Effectiveness Trial for At-Risk College Students |
- eating disorder symptoms, risk for future eating disorder and obesity onset [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- mediators to intervention effects [ Time Frame: 2 years ] [ Designated as safety issue: No ]We will test whether the dissonance program intervention effects are mediated by change in thin-ideal internalization
- moderators to program effects [ Time Frame: 2 years ] [ Designated as safety issue: No ]We will test whether certain factors moderate program effects (e.g., initial body dissatisfaction level).
| Estimated Enrollment: | 432 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Brochure Condition
Participants in this condition receive an educational brochure about healthy body image via post-mail.
|
Behavioral: Body Project
Participants in this intervention attend four 1-hour group meetings (one per week for four consecutive weeks) in which they complete a series of written and verbal exercises intended to increase body satisfaction.
|
|
Experimental: Group Condition
Participants in this condition attend four 1-hour group meetings (one per week for four consecutive weeks) in which they complete a series of written and verbal exercises intended to increase body satisfaction.
|
Behavioral: Body Project
Participants in this intervention attend four 1-hour group meetings (one per week for four consecutive weeks) in which they complete a series of written and verbal exercises intended to increase body satisfaction.
|
Detailed Description:
Threshold and subthreshold eating disorders affect over 10% of young women and are associated with functional impairment, distress, psychiatric comorbidity, medical complications, mortality, and risk for obesity onset. Accordingly, a pressing public healthy priority is to develop effective prevention programs for eating pathology. The proposed project will be the first effectiveness trial to test whether an eating disorder prevention program with strong empirical support from efficacy trials produces effects under ecologically valid conditions among high-risk female college students, which is a vital step toward widespread dissemination of programs developed with NIH funding. The proposed cost-effectiveness analyses and examination of process factors that predict larger intervention effects will also represent novel contributions to the literature.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- (1) is a registered student at a participating school, (2) self-reports body image concerns
Exclusion Criteria:
- meets DSM-IV criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder
Contacts and Locations| United States, Oregon | |
| Northwest Christian University | |
| Eugene, Oregon, United States, 97401 | |
| University of Oregon | |
| Eugene, Oregon, United States, 97403 | |
| United States, Pennsylvania | |
| Drexel University | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Temple University | |
| Philadelphia, Pennsylvania, United States, 19122 | |
| United States, Texas | |
| University of Texas at Austin | |
| Austin, Texas, United States, 78712 | |
| Southwestern University | |
| Georgetown, Texas, United States, 78626 | |
| Principal Investigator: | Eric Stice, Ph.D. | Oregon Research Institute |
| Principal Investigator: | Meghan Butryn, Ph.D. | Drexel University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Oregon Research Institute |
| ClinicalTrials.gov Identifier: | NCT01126918 History of Changes |
| Other Study ID Numbers: | MH086582 |
| Study First Received: | May 18, 2010 |
| Last Updated: | April 24, 2013 |
| Health Authority: | United States: National Institutes of Health |
Keywords provided by Oregon Research Institute:
|
Eating Disorders Obesity Body Dissatisfaction Female |
Additional relevant MeSH terms:
|
Eating Disorders Obesity Mental Disorders Overnutrition |
Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013