NCT00050570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2002

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2012

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

11.2 years

First QC Date

December 16, 2002

Last Update Submit

March 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Onset of an eating disorder

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

    2 years

Secondary Outcomes (1)

  • Change in eating disorder behaviors

    2 years

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Web-based intervention to reduce eating disorder risk factors

Control

NO INTERVENTION

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.

Interventions

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • College students at risk for developing an eating disorder

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University, Dept. of Psychiatry and Behavioral Sciences

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 16, 2002

First Posted

December 17, 2002

Study Start

February 1, 2001

Primary Completion

April 30, 2012

Study Completion

April 30, 2012

Last Updated

March 18, 2020

Record last verified: 2020-03

Locations