Testing an Internet-Based Intervention for Preventing Eating Disorders
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| First Received Date ICMJE | July 6, 2009 | ||||||||
| Last Updated Date | June 5, 2012 | ||||||||
| Start Date ICMJE | August 2009 | ||||||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Eating disorder diagnoses [ Time Frame: Measured after 10 weeks, 1 year, and 1.5 years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00934583 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Testing an Internet-Based Intervention for Preventing Eating Disorders | ||||||||
| Official Title ICMJE | Preventing Eating Disorders and Reducing Comorbidity | ||||||||
| Brief Summary | This study will examine the ability of an Internet-based program to prevent college-aged women from developing eating disorders. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Eating Disorders | ||||||||
| Intervention ICMJE | 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+ |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 549 | ||||||||
| Completion Date | April 2012 | ||||||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria for Primary Aim:
Inclusion Criteria for Secondary Aim:
Exclusion Criteria for Both Primary and Secondary Aims:
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| Gender | Female | ||||||||
| Ages | 18 Years to 25 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00934583 | ||||||||
| Other Study ID Numbers ICMJE | R01 MH081124, R01MH081124, R01 MH081124, DSIR 84-CTP | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Craig Barr Taylor, Stanford University | ||||||||
| Study Sponsor ICMJE | Stanford University | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||||||
| Verification Date | May 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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