Motivating Factors That Play a Role in Bulimia Nervosa
| Tracking Information | |||||
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| First Received Date ICMJE | March 15, 2006 | ||||
| Last Updated Date | December 18, 2012 | ||||
| Start Date ICMJE | May 2005 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00304174 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Motivating Factors That Play a Role in Bulimia Nervosa | ||||
| Official Title ICMJE | Translational Research on Eating Disorders: Behavioral Assessment of Motivation to Eat | ||||
| Brief Summary | This study will evaluate whether people with bulimia nervosa will binge eat in a structured laboratory setting and display behavioral patterns similar to those of individuals who are dependent on drugs. |
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| Detailed Description | Bulimia nervosa (BN) is a serious eating disorder that is characterized by frequent uncontrolled eating binges. These binges are often followed by compensatory behavior, including the following: self-induced vomiting; misuse of laxatives, diuretics, enemas, or other medications to induce purging; fasting; or excessive exercise. If left untreated, BN can lead to many serious health issues: tooth decay; irregular menstruation; bowel damage; constipation; heart and kidney disease; intestinal damage; puffiness, especially in the face and fingers; increased hair growth on the face and body; and mineral imbalances in the body. Similar to drug abuse disorders, food-related thinking and disordered eating behavior can interfere with other occupational and social activities, as well. This study will evaluate whether people with bulimia nervosa will binge eat in a structured laboratory setting and display behavioral patterns similar to those of individuals who are dependent on drugs. Interested participants will first report to the study site for a screening visit, during which they will be assessed for eligibility using blood tests and an interview. Eligible participants will return to the study site on 3 additional days. Participants will be asked to refrain from eating or drinking between 10 P.M. each night before reporting to the study site and 10 A.M. the next day. Each day, participants will receive breakfast, after which they will not be allowed to eat or drink until the end of the day. Participants will then use a computer program to earn food (a yogurt shake) by tapping on the keyboard. More taps on the keyboard will result in a larger amount of food earned by the end of the day. Once experimentation is complete on Day 1, participants will be instructed to eat as much as they can. On Days 2 and 3, participants will be given a small serving of the yogurt shake prior to beginning the computer task. Following the computer task, they will be instructed to either eat until they are comfortable (without restricting or binging), or eat as much as they can. A private bathroom will be available if needed. All participants, including those who did not meet criteria for participation, will be offered treatment at the study clinic once the study is complete. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Participants who meet DSM-IV criteria for bulimia nervosa and control participants who weigh between 80 and 120% of ideal weight |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Motivation to eat
Participants will use a computer program to earn food (a yogurt shake) by tapping on the keyboard. More taps on the keyboard will result in a larger amount of food earned by the end of the day. Once experimentation is complete on Day 1, participants will be instructed to eat as much as they can. On Days 2 and 3, participants will be given a small serving of the yogurt shake prior to beginning the computer task. Following the computer task, they will be instructed to either eat until they are comfortable (without restricting or binging), or eat as much as they can. |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 90 | ||||
| Estimated Completion Date | June 2017 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Participants with Bulimia Nervosa:
Control Group:
Exclusion Criteria: Participants with Bulimia Nervosa:
Control Group:
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| Gender | Both | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00304174 | ||||
| Other Study ID Numbers ICMJE | #5049/#6178R, R21MH065024-05, DNBBS 72-NBR | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | New York State Psychiatric Institute | ||||
| Study Sponsor ICMJE | New York State Psychiatric Institute | ||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||
| Investigators ICMJE |
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| Information Provided By | New York State Psychiatric Institute | ||||
| Verification Date | December 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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