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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Texas at Austin
Drexel University
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT01126918
First received: May 18, 2010
Last updated: May 2, 2014
Last verified: May 2014
  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

Resource links provided by NLM:


Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • eating disorder symptoms, risk for future eating disorder and obesity onset [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126918

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
Temple University
Philadelphia, Pennsylvania, United States, 19122
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas at Austin
Austin, Texas, United States, 78712
Southwestern University
Georgetown, Texas, United States, 78626
Sponsors and Collaborators
Oregon Research Institute
University of Texas at Austin
Drexel University
Investigators
Principal Investigator: Eric Stice, Ph.D. Oregon Research Institute
Principal Investigator: Meghan Butryn, Ph.D. Drexel University
  More 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: May 2, 2014
Health Authority: United States: National Institutes of Health

Keywords provided by Oregon Research Institute:
Eating Disorders
Obesity
Body Dissatisfaction
Female

Additional relevant MeSH terms:
Disease
Eating Disorders
Obesity
Body Weight
Mental Disorders
Nutrition Disorders
Overnutrition
Overweight
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014