Testing an Internet-Based Intervention for Preventing Eating Disorders

March 16, 2020 updated by: Craig Barr Taylor, Stanford University

Preventing Eating Disorders and Reducing Comorbidity

This study will examine the ability of an Internet-based program to prevent college-aged women from developing eating disorders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Approximately 2% to 4% of college-aged women suffer from eating disorders (EDs), and many more are at risk of developing them. A previous Internet-based intervention called Student Bodies (SB), which focused on body image concerns, was effective in reducing risk factors for EDs among college-aged women. However, the original SB program did not account for certain other risk factors, such as depression and compensatory behaviors like self-induced vomiting, over-exercising, or use of diuretics. Image and Mood (IaM) is an enhanced version of the SB program and takes into account depressive symptoms and the use of compensatory behaviors. This study will examine whether IaM will reduce ED risk factors in a large population of college women who are at high risk of developing EDs.

Participation in this study will last 10 weeks. Participants will be randomly assigned to either receive the IaM program or be placed on a wait list. The IaM program, which will be delivered through the Internet, will provide information about nutrition, exercise, body image, and coping skills-including examples and exercises. It will also include an online message board monitored by a study psychologist. Each week the IaM participants will monitor their behavior, keep a journal about their experiences, and answer self-report questionnaires. Assessments of eating disorder symptoms; weight and shape concerns; depressive symptoms; and incidence of substance abuse, anxiety, or depressive disorders will be completed post-treatment and at 1- and 1.5-month follow-ups. Those assigned to the wait list will complete these assessments and then receive the IaM program after the last follow-up.

Study Type

Interventional

Enrollment (Actual)

549

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

  • United States
    • California
      • Stanford, California, United States, 94305-5722
        • Stanford University School of Medicine
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University in St. Louis

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

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria for Primary Aim:

  • Access to a computer with an Internet connection
  • Weight Concerns Scale score greater than or equal to 47
  • Presence of one additional risk factor, including a history of teasing, a history of depression, or low levels of compensatory behaviors (defined as less than four times per month)

Inclusion Criteria for Secondary Aim:

  • Access to a computer with an Internet connection
  • Weight Concerns Scale score greater than or equal to 47

Exclusion Criteria for Both Primary and Secondary Aims:

  • Current diagnosis of an eating disorder
  • Treated for an eating disorder within the past 6 months
  • Currently receiving psychological treatment for an eating disorder or depressive disorder
  • Started a new psychiatric medication within the past 2 months
  • Exhibiting a level of psychopathology that would interfere with participation (e.g., acutely suicidal)

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Image and Mood (IaM) program
Participants will participate in the IaM program.
Behavioral: Image and Mood (IaM) program
A 10-week Internet-based intervention focused on (1) identifying and challenging automatic thoughts in order to improve body image and reduce negative affect, (2) developing adaptive emotion and behavior regulation skills associated with preventing disordered eating and negative affect, and (3) teaching relapse prevention skills. The program includes an online discussion group moderated by a study clinician.
Other Names:
  • Student Bodies+
No Intervention: Wait-list control
Participants will be placed on a wait list until after participants in the IaM group have completed all assessments. After that, these participants will be offered the option to complete the IaM program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Eating disorder diagnoses
Time Frame: Measured after 10 weeks, 1 year, and 1.5 years
Measured after 10 weeks, 1 year, and 1.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight Concerns Scale
Time Frame: Measured after 10 weeks, 1 year, and 1.5 years
Measured after 10 weeks, 1 year, and 1.5 years
Eating Disorder Examination Questionnaires (EDE-Q)
Time Frame: Measured after 10 weeks, 1 year, and 1.5 years
Measured after 10 weeks, 1 year, and 1.5 years
Depressive symptoms, as measured by the Beck Depression Inventory and Center for Epidemiologic Studies-Depression Scale
Time Frame: Measured after 10 weeks, 1 year, and 1.5 years
Measured after 10 weeks, 1 year, and 1.5 years
Combined incidence of substance abuse, alcohol abuse, anxiety disorders, and depressive disorders
Time Frame: Measured after 10 weeks, 1 year, and 1.5 years
Measured after 10 weeks, 1 year, and 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institute of Mental Health (NIMH)
Washington University School of Medicine

Investigators

  • Principal Investigator: C. Barr Taylor, MD, Stanford University
  • Principal Investigator: Denise Wilfley, PhD, Washington University School of Medicine

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

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

August 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

July 6, 2009

First Submitted That Met QC Criteria

July 6, 2009

First Posted (Estimate)

July 8, 2009

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH081124 (U.S. NIH Grant/Contract)

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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