- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00050570
Reducing Eating Disorder Risk Factors
Interventions to Reduce Eating Disorder Risk Factors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Female college students who use unhealthy weight control methods and have body image concerns may be at risk for developing an eating disorder. Developing and evaluating interventions to reduce eating disorders in high-risk populations is of great public health importance.
Participants are randomly assigned to either join a web-based risk-reduction program or receive no intervention. The 9-week risk-reduction program focuses on reducing body image and weight/shape concerns, identifying the risks of eating disorders, and increasing healthy weight regulation practices. The program includes weekly readings, writing assignments, and participation in a moderated electronic discussion group. Changes in body mass index (BMI) and the occurrence of major stressors and psychiatric events are assessed to determine their impact on the incidence of eating disorders. One-year incidence of eating disorders is determined by a diagnostic interview, and follow up may continue for up to 2.5 years.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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Stanford, California, United States, 94305
- Stanford University, Dept. of Psychiatry and Behavioral Sciences
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- College students at risk for developing an eating disorder
Exclusion Criteria:
- Suicidal or other severe psychopathology
- Alcohol or drug abuse
- Body mass index (BMI) < 18 or > 32
- Current diagnosis of anorexia nervosa, binge eating disorder, or bulimia nervosa and have been in treatment within the past 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
An 8-week, Internet- based, structured cognitive- behavioral program combined with an online, asynchronous, moderated discussion group.
|
|
|
No Intervention: Control
The waitlist control group was only contacted at the time of assessments and was offered the intervention at the end of the study, after the 2-year follow-up assessment was completed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Onset of an eating disorder
Time Frame: 2 years
|
The main outcome is the onset of an eating disorder, as defined by DSM-IV
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in eating disorder behaviors
Time Frame: 2 years
|
Eating disorder behaviors as measured by the Eating Disorder Examination.
We will also measure attitudes related to eating disorder onset risk
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH060453 (U.S. NIH Grant/Contract)
- DSIR CT-P (Other Identifier: NIMH)
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