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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robin M. Masheb, Yale University
ClinicalTrials.gov Identifier:
NCT00601653
First received: January 23, 2008
Last updated: July 20, 2012
Last verified: July 2012
  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
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)

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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Weight loss [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: September 2007
Study Completion Date: March 2010
Primary Completion Date: March 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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601653

Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Robin M. Masheb, PhD Yale University
  More Information

Publications:
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, 49, 821-829. PMCID: PMC3223390

Responsible Party: Robin M. Masheb, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT00601653     History of Changes
Other Study ID Numbers: R01 MH082629, 5R21MH082629, DATR A2-AID
Study First Received: January 23, 2008
Last Updated: July 20, 2012
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Binge Eating Disorder
BED
Nutrition
Energy Density
Cognitive Behavioral Therapy
CBT

Additional relevant MeSH terms:
Overweight
Eating Disorders
Bulimia
Binge-Eating Disorder
Disease
Body Weight
Signs and Symptoms
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014