Effectiveness of Cognitive Behavioral Therapy Plus Nutritional Counseling in Promoting Weight Loss in People With Binge Eating Disorder
Primary Purpose
Binge Eating Disorder, Obesity, Overweight
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive behavioral therapy plus general nutrition counseling (CBT+GN)
Cognitive behavioral therapy plus low energy density diet counseling (CBT+LED)
Sponsored by
About this trial
This is an interventional treatment trial for Binge Eating Disorder focused on measuring Binge Eating Disorder, BED, Nutrition, Energy Density, Cognitive Behavioral Therapy, CBT
Eligibility Criteria
Inclusion Criteria:
- Body mass index (BMI) greater than or equal to 30
- Meets DSM-IV criteria for BED
Exclusion Criteria:
- Co-existing physical and/or psychiatric conditions that require different treatments than CBT (e.g., bipolar disorder, psychotic illnesses), and/or require more intensive treatment or hospitalization (e.g., suicidality, severe mood disorders)
- Meets criteria for current substance abuse or dependence
- Currently receiving psychiatric, psychological, behavioral, or pharmacologic treatment that is known to affect weight or eating
- Any physical conditions, such as diabetes, known to affect weight or eating
- Pregnant, breastfeeding, or plans to become pregnant during the treatment period
- Cardiac disease, including ischemic heart disease, congestive heart failure, conduction abnormalities, or a history of heart attack
- Serious neurologic illnesses (e.g., seizure history) or medical illnesses (e.g., impaired hepatic or renal function)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Cognitive behavioral therapy plus general nutrition counseling
Cognitive behavioral therapy plus low energy density diet counseling
Outcomes
Primary Outcome Measures
Weight loss
Secondary Outcome Measures
Outcomes related to binge eating disorder (e.g., binge eating, attitudinal features of eating disorders, psychological functioning)
Outcomes related to energy density (e.g., energy density, caloric intake, fat intake, fruit and vegetable consumption, hunger)
Health status (e.g., lipid profile, blood pressure)
Full Information
NCT ID
NCT00601653
First Posted
January 23, 2008
Last Updated
March 31, 2020
Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00601653
Brief Title
Effectiveness of Cognitive Behavioral Therapy Plus Nutritional Counseling in Promoting Weight Loss in People With Binge Eating Disorder
Official Title
CBT and Dieting: Effects on Psychopathology and Weight in BED
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the effectiveness of adding nutritional counseling to cognitive behavioral therapy in treating obese people with binge eating disorder.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating Disorder, Obesity, Overweight
Keywords
Binge Eating Disorder, BED, Nutrition, Energy Density, Cognitive Behavioral Therapy, CBT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Cognitive behavioral therapy plus general nutrition counseling
Arm Title
2
Arm Type
Experimental
Arm Description
Cognitive behavioral therapy plus low energy density diet counseling
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy plus general nutrition counseling (CBT+GN)
Intervention Description
CBT+GN includes 21 sessions over 6 months. Each treatment session includes 40 minutes of CBT and 20 minutes of nutritional counseling.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy plus low energy density diet counseling (CBT+LED)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
Measured at Year 1
Secondary Outcome Measure Information:
Title
Outcomes related to binge eating disorder (e.g., binge eating, attitudinal features of eating disorders, psychological functioning)
Time Frame
Measured at Year 1
Title
Outcomes related to energy density (e.g., energy density, caloric intake, fat intake, fruit and vegetable consumption, hunger)
Time Frame
Measured at Year 1
Title
Health status (e.g., lipid profile, blood pressure)
Time Frame
Measured at Year 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Body mass index (BMI) greater than or equal to 30
Meets DSM-IV criteria for BED
Exclusion Criteria:
Co-existing physical and/or psychiatric conditions that require different treatments than CBT (e.g., bipolar disorder, psychotic illnesses), and/or require more intensive treatment or hospitalization (e.g., suicidality, severe mood disorders)
Meets criteria for current substance abuse or dependence
Currently receiving psychiatric, psychological, behavioral, or pharmacologic treatment that is known to affect weight or eating
Any physical conditions, such as diabetes, known to affect weight or eating
Pregnant, breastfeeding, or plans to become pregnant during the treatment period
Cardiac disease, including ischemic heart disease, congestive heart failure, conduction abnormalities, or a history of heart attack
Serious neurologic illnesses (e.g., seizure history) or medical illnesses (e.g., impaired hepatic or renal function)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin M. Masheb, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
22005587
Citation
Masheb RM, Grilo CM, Rolls BJ. A randomized controlled trial for obesity and binge eating disorder: low-energy-density dietary counseling and cognitive-behavioral therapy. Behav Res Ther. 2011 Dec;49(12):821-9. doi: 10.1016/j.brat.2011.09.006. Epub 2011 Sep 28.
Results Reference
result
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Effectiveness of Cognitive Behavioral Therapy Plus Nutritional Counseling in Promoting Weight Loss in People With Binge Eating Disorder
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