- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01126918
Eating Disorders Prevention: An Effectiveness Trial for At-Risk College Students
September 29, 2016 updated by: Oregon Research Institute
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
432
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Eugene, Oregon, United States, 97403
- University of Oregon
-
Eugene, Oregon, United States, 97401
- Northwest Christian University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19122
- Temple University
-
Philadelphia, Pennsylvania, United States, 19104
- Drexel University
-
-
Texas
-
Austin, Texas, United States, 78712
- University of Texas at Austin
-
Georgetown, Texas, United States, 78626
- Southwestern University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Brochure Condition
Participants in this condition receive an educational brochure about healthy body image via post-mail.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
eating disorder symptoms, risk for future eating disorder and obesity onset
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mediators to intervention effects
Time Frame: 2 years
|
We will test whether the dissonance program intervention effects are mediated by change in thin-ideal internalization
|
2 years
|
moderators to program effects
Time Frame: 2 years
|
We will test whether certain factors moderate program effects (e.g., initial body dissatisfaction level).
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Meghan Butryn, Ph.D., Drexel University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Stice E, Desjardins CD, Rohde P. Young women who develop anorexia nervosa exhibit a persistently low premorbid body weight on average: A longitudinal investigation of an important etiologic clue. J Psychopathol Clin Sci. 2022 Jul;131(5):479-492. doi: 10.1037/abn0000762. Epub 2022 Jun 2.
- Stice E, Rohde P, Shaw H, Desjardins C. Weight suppression increases odds for future onset of anorexia nervosa, bulimia nervosa, and purging disorder, but not binge eating disorder. Am J Clin Nutr. 2020 Oct 1;112(4):941-947. doi: 10.1093/ajcn/nqaa146.
- Stice E, Desjardins CD, Rohde P, Shaw H. Sequencing of symptom emergence in anorexia nervosa, bulimia nervosa, binge eating disorder, and purging disorder and relations of prodromal symptoms to future onset of these disorders. J Abnorm Psychol. 2021 May;130(4):377-387. doi: 10.1037/abn0000666.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
May 18, 2010
First Submitted That Met QC Criteria
May 18, 2010
First Posted (Estimate)
May 20, 2010
Study Record Updates
Last Update Posted (Estimate)
September 30, 2016
Last Update Submitted That Met QC Criteria
September 29, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MH086582
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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