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

This study is currently recruiting participants.

Verified August 2011 by Yale University

First Received on January 26, 2009. Last Updated on August 3, 2011 History of Changes

Sponsor:	Yale University
Collaborator:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00829283

Purpose

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.

Condition	Intervention
Obesity Binge Eating	Behavioral: Behavioral Weight Loss Behavioral: Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy Drug: Placebo Drug: Sibutramine

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control

Drug Information available for: Sibutramine Sibutramine hydrochloride monohydrate

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

Binge Eating [ Time Frame: 6 months treatment; 6 and 12 months follow-up post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

BMI [ Time Frame: 6 months treatment; 6 and 12 months follow-up post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	175
Study Start Date:	November 2008
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Standard Care	Behavioral: Behavioral Weight Loss weekly individual sessions for 6 months
Experimental: 2 Stepped-care	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 15 mg daily

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829283

Locations

United States, Connecticut
Yale School of Medicine	Recruiting
New Haven, Connecticut, United States, 06520
Contact: Loren Gianini, Ph.D. 203-737-5537 loren.gianini@yale.edu
Contact: Robin M Masheb, Ph.D. 203-785-7807 robin.masheb@yale.edu
Sub-Investigator: Robin M Masheb, Ph.D.
Sub-Investigator: Marney White, Ph.D.
Principal Investigator: Carlos M Grilo, Ph.D.

Sponsors and Collaborators

Yale University

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

Investigators

Principal Investigator:

Carlos M Grilo, PhD

Yale University

More Information

No publications provided

Responsible Party:	Carlos M. Grilo, Ph.D., Yale School of Medicine
ClinicalTrials.gov Identifier:	NCT00829283 History of Changes
Other Study ID Numbers:	DK49587, R01DK049587
Study First Received:	January 26, 2009
Last Updated:	August 3, 2011
Health Authority:	United States: Federal Government

Keywords provided by Yale University:

Experimental
Comparator

Additional relevant MeSH terms:

Bulimia
Bulimia Nervosa
Binge-Eating Disorder
Obesity
Weight Loss
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Body Weight Changes
Sibutramine
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012