Testing an Internet-Based Intervention for Preventing Eating Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00934583|
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : June 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Eating Disorders||Behavioral: Image and Mood (IaM) program||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||549 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preventing Eating Disorders and Reducing Comorbidity|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
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 Name: 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.
- Eating disorder diagnoses [ Time Frame: Measured after 10 weeks, 1 year, and 1.5 years ]
- Weight Concerns Scale [ Time Frame: 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 ]
- 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 ]
- Combined incidence of substance abuse, alcohol abuse, anxiety disorders, and depressive disorders [ Time Frame: Measured after 10 weeks, 1 year, and 1.5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934583
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305-5722|
|United States, Missouri|
|Washington University in St. Louis|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||C. Barr Taylor, MD||Stanford University|
|Principal Investigator:||Denise Wilfley, PhD||Washington University School of Medicine|