NCT00537758

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2007

Completed
Last Updated

March 31, 2020

Status Verified

September 1, 2007

First QC Date

September 27, 2007

Last Update Submit

March 30, 2020

Conditions

Binge Eating DisorderObesity

Keywords

binge eating disordercognitive behavior therapycombination therapyobesityweight lossbody weightclinical trialdietary restrictionovereatingweight control

Outcome Measures

Primary Outcomes (2)

  • Binge Eating

  • BMI

Study Arms (3)

1

EXPERIMENTAL

Cognitive Behavior Therapy

Behavioral: Cognitive Behavior Therapy

2

EXPERIMENTAL

Behavioral Weight Loss Treatment

Behavioral: Behavioral Weight Loss Treatment

3

EXPERIMENTAL

CBT + BWL

Behavioral: CBT and BWL

Interventions

Cognitive Behavior TherapyBEHAVIORAL
1
CBT and BWLBEHAVIORAL
3
Behavioral Weight Loss TreatmentBEHAVIORAL
2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Binge Eating
  • Overweight

You may not qualify if:

  • Pregnancy
  • Current cardiac disease
  • Serious neurologic illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Psychiatric Research at Congress Place

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

  • Grilo CM, Pittman B. Exploring Dietary Restraint as a Mediator of Behavioral and Cognitive-Behavioral Treatments on Outcomes for Patients With Binge-Eating Disorder With Obesity. Int J Eat Disord. 2024 Dec;57(12):2475-2481. doi: 10.1002/eat.24288. Epub 2024 Sep 9.

    PMID: 39247962DERIVED

MeSH Terms

Conditions

Binge-Eating DisorderObesityWeight LossBody WeightHyperphagia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Carlos M. Grilo, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 27, 2007

First Posted

October 1, 2007

Study Start

July 1, 2002

Last Updated

March 31, 2020

Record last verified: 2007-09

Locations

US(1)