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Treatment for Obesity and Binge Eating Disorder

Primary Purpose

Binge Eating Disorder, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavior Therapy
CBT and BWL
Behavioral Weight Loss Treatment
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, cognitive behavior therapy, combination therapy, obesity, weight loss, body weight, clinical trial, dietary restriction, overeating, weight control

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Binge Eating
  • Overweight

Exclusion Criteria:

  • Pregnancy
  • Current cardiac disease
  • Serious neurologic illnesses

Sites / Locations

  • Yale Psychiatric Research at Congress Place

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Cognitive Behavior Therapy

Behavioral Weight Loss Treatment

CBT + BWL

Outcomes

Primary Outcome Measures

Binge Eating
BMI

Secondary Outcome Measures

Full Information

First Posted
September 27, 2007
Last Updated
March 30, 2020
Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00537758
Brief Title
Treatment for Obesity and Binge Eating Disorder
Official Title
Treatment for Obesity and Binge Eating Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. Study Description

Brief Summary
This study is a test of cognitive behavioral therapy(CBT) and behavioral weight loss (BWL) treatments for obese patients with binge eating disorder (BED). The study involves a comparison of three treatment conditions: (1) CBT; (2) BWL, and (3) a sequential (two-part) treatment consisting of CBT followed by BWL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating Disorder, Obesity
Keywords
binge eating disorder, cognitive behavior therapy, combination therapy, obesity, weight loss, body weight, clinical trial, dietary restriction, overeating, weight control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Cognitive Behavior Therapy
Arm Title
2
Arm Type
Experimental
Arm Description
Behavioral Weight Loss Treatment
Arm Title
3
Arm Type
Experimental
Arm Description
CBT + BWL
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy
Intervention Type
Behavioral
Intervention Name(s)
CBT and BWL
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Weight Loss Treatment
Primary Outcome Measure Information:
Title
Binge Eating
Title
BMI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Binge Eating Overweight Exclusion Criteria: Pregnancy Current cardiac disease Serious neurologic illnesses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos M. Grilo, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Psychiatric Research at Congress Place
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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Treatment for Obesity and Binge Eating Disorder

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