MedTrace Logo

Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care

NCT00829283 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2020-04-03

Study results available
· View outcomes & findings →

Summary

This controlled study will test the effectiveness of a stepped-care approach to a standard behavioral weight loss treatment for obese patients with Binge Eating Disorder (BED). The major question is whether the stepped-care approach, which begins with behavioral weight loss and then follows a decision tree for additional interventions based on early treatment response is superior to standard behavioral treatment.

Conditions

Interventions

BEHAVIORAL

Behavioral Weight Loss

weekly individual sessions for 6 months

BEHAVIORAL

Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy

weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months

DRUG

Placebo

One pill daily

DRUG

Sibutramine/Orlistat

Sibutramine 15 mg daily or Orlistat 120mg TID

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Carlos M Grilo, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00829283 on ClinicalTrials.gov