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Reducing Eating Disorder Risk Factors

Primary Purpose

Eating Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-based intervention to reduce eating disorder risk factors
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eating Disorders

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford University, Dept. of Psychiatry and Behavioral Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

An 8-week, Internet- based, structured cognitive- behavioral program combined with an online, asynchronous, moderated discussion group.

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.

Outcomes

Primary Outcome Measures

Onset of an eating disorder
The main outcome is the onset of an eating disorder, as defined by DSM-IV

Secondary Outcome Measures

Change in eating disorder behaviors
Eating disorder behaviors as measured by the Eating Disorder Examination. We will also measure attitudes related to eating disorder onset risk

Full Information

First Posted
December 16, 2002
Last Updated
March 16, 2020
Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00050570
Brief Title
Reducing Eating Disorder Risk Factors
Official Title
Interventions to Reduce Eating Disorder Risk Factors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
April 30, 2012 (Actual)
Study Completion Date
April 30, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether a web-based program is effective in reducing the incidence of eating disorders in college women who are at high risk for developing an eating disorder.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
An 8-week, Internet- based, structured cognitive- behavioral program combined with an online, asynchronous, moderated discussion group.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Web-based intervention to reduce eating disorder risk factors
Primary Outcome Measure Information:
Title
Onset of an eating disorder
Description
The main outcome is the onset of an eating disorder, as defined by DSM-IV
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Change in eating disorder behaviors
Description
Eating disorder behaviors as measured by the Eating Disorder Examination. We will also measure attitudes related to eating disorder onset risk
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Stanford University, Dept. of Psychiatry and Behavioral Sciences
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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Reducing Eating Disorder Risk Factors

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