Overview

This trial is active, not recruiting.

Conditions obesity, binge eating
Treatments behavioral weight loss, behavioral weight loss + guided self-help cognitive-behavioral therapy, placebo, sibutramine
Sponsor Yale University
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date November 2008
End date May 2013
Trial size 175 participants
Trial identifier NCT00829283, DK49587, R01DK049587

Summary

This controlled study will test the effectiveness of a stepped-care approach to a standard behavioral weight loss treatment for obese patients with 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Standard Care
behavioral weight loss
weekly individual sessions for 6 months
(Experimental)
Stepped-care
behavioral weight loss
weekly individual sessions for 6 months
behavioral weight loss + guided self-help cognitive-behavioral therapy
weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months
placebo
One pill daily
sibutramine
15 mg daily

Primary Outcomes

Measure
Binge Eating
time frame: 6 months treatment; 6 and 12 months follow-up post-treatment

Secondary Outcomes

Measure
BMI
time frame: 6 months treatment; 6 and 12 months follow-up post-treatment

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion criteria: - Obese (BMI>=30) Exclusion criteria: - Medication regimen that represents medical contraindication to sibutramine - Serious unstable or uncontrolled medical conditions that represent contraindication to sibutramine - Pregnancy

Additional Information

Official title Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care
Principal investigator Carlos M Grilo, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Yale University.