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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00601653 |
Purpose
This study will evaluate the effectiveness of adding nutritional counseling to cognitive behavioral therapy in treating obese people with binge eating disorder.
| Condition | Intervention |
|---|---|
|
Obesity Overweight Eating Disorders |
Behavioral: Cognitive behavioral therapy plus general nutrition counseling (CBT+GN) Behavioral: Cognitive behavioral therapy plus low energy density diet counseling (CBT+LED) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | CBT and Dieting: Effects on Psychopathology and Weight in BED |
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Cognitive behavioral therapy plus general nutrition counseling
|
Behavioral: Cognitive behavioral therapy plus general nutrition counseling (CBT+GN)
CBT+GN includes 21 sessions over 6 months. Each treatment session includes 40 minutes of CBT and 20 minutes of nutritional counseling.
|
|
Experimental: 2
Cognitive behavioral therapy plus low energy density diet counseling
|
Behavioral: Cognitive behavioral therapy plus low energy density diet counseling (CBT+LED)
CBT+LED includes 21 sessions over 6 months. Each treatment session includes 40 minutes of CBT and 20 minutes of nutritional counseling that centers upon eating higher volumes of low-calorie foods.
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Binge eating disorder (BED) is one of the most common eating disorders, with millions of affected Americans. The majority of people who binge eat are mildly to severely overweight, but people of normal weight can also have BED. People with BED frequently eat excessive amounts of food in a short period of time, often feeling a loss of control over their urge to eat. Following a binge eating episode, the person usually experiences feelings of guilt, depression, embarrassment, and disgust. Beyond the psychological distress caused by binge eating, people who binge eat are at a higher risk for more serious health problems associated with weight gain, including high blood pressure, diabetes, heart disease, high cholesterol, and stroke. Previous studies on BED have found cognitive behavioral therapy (CBT) to be the most effective treatment in improving binge eating habits, attitudinal features of eating disorders, and psychological functioning. However, CBT alone has not been nearly as effective in producing clinically significant weight loss in those who are overweight. This study will evaluate the effectiveness of adding nutritional counseling to CBT in treating obese people with BED.
Participants in this 1-year study will be randomly assigned to one of two treatment groups: CBT plus general nutrition counseling (CBT+GN) or CBT plus low energy density diet counseling (CBT+LED). All participants will receive 21 hourly individual treatment sessions over a 6-month period. Sessions will be weekly for Weeks 1 to 16 and every other week for Weeks 17 to 26. Each treatment session will include 40 minutes of CBT and 20 minutes of nutritional counseling (GN or LED). Assessments will include interviews and questionnaires about symptoms and height and weight measurements. These assessments will occur at baseline, monthly during treatment, and at 6 months post-treatment. At the end of treatment, participants will also have blood drawn to determine lipid levels and will be asked to complete two food intake interviews by phone.
Eligibility| Ages Eligible for Study: | 21 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Robin Masheb, Yale University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00601653 History of Changes |
| Other Study ID Numbers: | R01 MH082629, DATR A2-AID |
| Study First Received: | January 23, 2008 |
| Last Updated: | June 4, 2009 |
| Health Authority: | United States: Federal Government |
|
Binge Eating Disorder BED Nutrition |
Energy Density Cognitive Behavioral Therapy CBT |
|
Bulimia Eating Disorders Obesity Overweight Binge-Eating Disorder Hyperphagia |
Signs and Symptoms, Digestive Signs and Symptoms Mental Disorders Overnutrition Nutrition Disorders Body Weight |