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

March 31, 2020 updated by: Yale University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight loss
Time Frame: Measured at Year 1
Measured at Year 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Outcomes related to binge eating disorder (e.g., binge eating, attitudinal features of eating disorders, psychological functioning)
Time Frame: Measured at Year 1
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
Measured at Year 1
Health status (e.g., lipid profile, blood pressure)
Time Frame: Measured at Year 1
Measured at Year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Robin M. Masheb, PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria

January 23, 2008

First Posted (Estimate)

January 28, 2008

Study Record Updates

Last Update Posted (Actual)

April 2, 2020

Last Update Submitted That Met QC Criteria

March 31, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0706002747
  • DATR A2-AID (NIH Adult Translational Research and Treatment Development)
  • 5R21MH082629 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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