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Effectiveness of Cognitive Behavioral Therapy Plus Nutritional Counseling in Promoting Weight Loss in People With Binge Eating Disorder

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
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
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.

Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Parallel Assignment
Primary Outcome Measure  Weight loss [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Outcomes related to binge eating disorder (e.g., binge eating, attitudinal features of eating disorders, psychological functioning) [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
Outcomes related to energy density (e.g., energy density, caloric intake, fat intake, fruit and vegetable consumption, hunger) [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
Health status (e.g., lipid profile, blood pressure) [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
Condition  Obesity
Overweight
Eating Disorders
Intervention  Behavioral: Cognitive behavioral therapy plus general nutrition counseling (CBT+GN)
Behavioral: Cognitive behavioral therapy plus low energy density diet counseling (CBT+LED)
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  50
Start Date  September 2007
Completion Date August 2010
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)
Gender Both
Ages 21 Years to 60 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Megan Roehrig, PhD     203-785-6040     megan.roehrig@yale.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00601653
Organization ID R01 MH082629
Secondary IDs †† DATR A2-AID
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Robin M. Masheb, PhD     Yale University    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date August 2008
First Received Date  January 23, 2008
Last Updated Date August 19, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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