Eating Disorders Prevention: An Effectiveness Trial for At-Risk College Students
Primary Purpose
Eating Disorders, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Body Project
Sponsored by
About this trial
This is an interventional prevention trial for Eating Disorders focused on measuring Eating Disorders, Obesity, Body Dissatisfaction, Female
Eligibility 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
Sites / Locations
- Northwest Christian University
- University of Oregon
- Drexel University
- University of Pennsylvania
- Temple University
- University of Texas at Austin
- Southwestern University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Brochure Condition
Group Condition
Arm Description
Participants in this condition receive an educational brochure about healthy body image via post-mail.
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.
Outcomes
Primary Outcome Measures
eating disorder symptoms, risk for future eating disorder and obesity onset
Secondary Outcome Measures
mediators to intervention effects
We will test whether the dissonance program intervention effects are mediated by change in thin-ideal internalization
moderators to program effects
We will test whether certain factors moderate program effects (e.g., initial body dissatisfaction level).
Full Information
NCT ID
NCT01126918
First Posted
May 18, 2010
Last Updated
September 29, 2016
Sponsor
Oregon Research Institute
Collaborators
University of Texas at Austin, Drexel University
1. Study Identification
Unique Protocol Identification Number
NCT01126918
Brief Title
Eating Disorders Prevention: An Effectiveness Trial for At-Risk College Students
Official Title
Eating Disorders Prevention: An Effectiveness Trial for At-Risk College Students
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute
Collaborators
University of Texas at Austin, Drexel University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Obesity
Keywords
Eating Disorders, Obesity, Body Dissatisfaction, Female
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
432 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brochure Condition
Arm Type
Active Comparator
Arm Description
Participants in this condition receive an educational brochure about healthy body image via post-mail.
Arm Title
Group Condition
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Body Project
Intervention Description
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.
Primary Outcome Measure Information:
Title
eating disorder symptoms, risk for future eating disorder and obesity onset
Time Frame
2 years
Secondary Outcome Measure Information:
Title
mediators to intervention effects
Description
We will test whether the dissonance program intervention effects are mediated by change in thin-ideal internalization
Time Frame
2 years
Title
moderators to program effects
Description
We will test whether certain factors moderate program effects (e.g., initial body dissatisfaction level).
Time Frame
2 years
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Stice, Ph.D.
Organizational Affiliation
Oregon Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Meghan Butryn, Ph.D.
Organizational Affiliation
Drexel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwest Christian University
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
University of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Facility Name
Southwestern University
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78626
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35653756
Citation
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.
Results Reference
derived
PubMed Identifier
34180702
Citation
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.
Results Reference
derived
PubMed Identifier
32534455
Citation
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.
Results Reference
derived
Learn more about this trial
Eating Disorders Prevention: An Effectiveness Trial for At-Risk College Students
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