Eating Disorders Prevention: An Effectiveness Trial for At-Risk College Students

Not Applicable

Completed

• Conditions: Eating Disorders; Obesity
• Interventions: Behavioral: Body Project

• Registration Number: NCT01126918
• Lead Sponsor: Oregon Research Institute

Brief Summary

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.

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-18
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-20
• Primary Completion: 2015-12
• Study Completion: 2016-02
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 432

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brochure Condition	Body Project	Participants in this condition receive an educational brochure about healthy body image via post-mail.
Group Condition	Body Project	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.

Primary Outcome Measures

Name	Time	Method
eating disorder symptoms, risk for future eating disorder and obesity onset	2 years

Secondary Outcome Measures

Name	Time	Method
mediators to intervention effects	2 years	We will test whether the dissonance program intervention effects are mediated by change in thin-ideal internalization
moderators to program effects	2 years	We will test whether certain factors moderate program effects (e.g., initial body dissatisfaction level).

Trial Locations

Locations (7)

Northwest Christian University; 🇺🇸 Eugene, Oregon, United States

University of Texas at Austin; 🇺🇸 Austin, Texas, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

Southwestern University; 🇺🇸 Georgetown, Texas, United States

Drexel University; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Oregon; 🇺🇸 Eugene, Oregon, United States