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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.
Study NCT00601653   Information provided by National Institute of Mental Health (NIMH)
First Received: January 23, 2008   Last Updated: March 10, 2009   History of Changes
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January 23, 2008
March 10, 2009
September 2007
Weight loss [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00601653 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Effectiveness of Cognitive Behavioral Therapy Plus Nutritional Counseling in Promoting Weight Loss in People With Binge Eating Disorder
CBT and Dieting: Effects on Psychopathology and Weight in BED

This study will evaluate the effectiveness of adding nutritional counseling to cognitive behavioral therapy in treating obese people with binge eating disorder.

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.

 
Interventional
Treatment, Randomized, Open Label, Parallel Assignment
  • 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)
  • Active Comparator: Cognitive behavioral therapy plus general nutrition counseling
  • Experimental: Cognitive behavioral therapy plus low energy density diet counseling
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
50
August 2010
August 2010   (final data collection date for primary outcome measure)

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)
Both
21 Years to 60 Years
No
Contact: Megan Roehrig, PhD 203-785-6040 megan.roehrig@yale.edu
United States
 
 
NCT00601653
Robin Masheb, Yale University School of Medicine
DATR A2-AID
National Institute of Mental Health (NIMH)
 
Principal Investigator: Robin M. Masheb, PhD Yale University
National Institute of Mental Health (NIMH)
March 2009

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