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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
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 23, 2008
    Last Updated
    March 31, 2020
    Sponsor
    Yale University
    Collaborators
    National Institute of Mental Health (NIMH)
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    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
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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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