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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01126918
• Other study ID #: MH086582
• Status: Completed
• Phase: N/A
• First received: May 18, 2010
• Last updated: September 29, 2016
• Start date: April 2010
• Est. completion date: February 2016

Study information

• Verified date: September 2016
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: National Institutes of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 432
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Disease
• Eating Disorders
• Feeding and Eating Disorders
• Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas
United States	Northwest Christian University	Eugene	Oregon
United States	University of Oregon	Eugene	Oregon
United States	Southwestern University	Georgetown	Texas
United States	Drexel University	Philadelphia	Pennsylvania
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Research Institute	Drexel University, University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eating disorder symptoms, risk for future eating disorder and obesity onset		2 years	Yes
Secondary	mediators to intervention effects	We will test whether the dissonance program intervention effects are mediated by change in thin-ideal internalization	2 years	No
Secondary	moderators to program effects	We will test whether certain factors moderate program effects (e.g., initial body dissatisfaction level).	2 years	No