Effectiveness of Cognitive Behavioral Therapy Plus Nutritional Counseling in Promoting Weight Loss in People With Binge Eating Disorder
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|ClinicalTrials.gov Identifier: NCT00601653|
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : July 23, 2012
|Condition or disease||Intervention/treatment||Phase|
|Binge Eating Disorder Obesity Overweight||Behavioral: Cognitive behavioral therapy plus general nutrition counseling (CBT+GN) Behavioral: Cognitive behavioral therapy plus low energy density diet counseling (CBT+LED)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||CBT and Dieting: Effects on Psychopathology and Weight in BED|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
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.
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.
- Weight loss [ Time Frame: Measured at Year 1 ]
- Outcomes related to binge eating disorder (e.g., binge eating, attitudinal features of eating disorders, psychological functioning) [ Time Frame: Measured at Year 1 ]
- Outcomes related to energy density (e.g., energy density, caloric intake, fat intake, fruit and vegetable consumption, hunger) [ Time Frame: Measured at Year 1 ]
- Health status (e.g., lipid profile, blood pressure) [ Time Frame: Measured at Year 1 ]
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): NCT00601653
|Principal Investigator:||Robin M. Masheb, PhD||Yale University|