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

This study is currently recruiting participants.

Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), July 2009

First Received: January 26, 2009 Last Updated: July 7, 2009 History of Changes

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Factorial Assignment, Efficacy Study
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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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
1: Active Comparator Standard Care	Behavioral: Behavioral Weight Loss weekly individual sessions for 6 months
2: Experimental 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: Kerstin Blomquist, Ph.D. 203-737-5537 kerstin.blomquist@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

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

More Information

No publications provided

Responsible Party:	Yale School of Medicine ( Carlos M. Grilo, Ph.D. )
Study ID Numbers:	DK49587
Study First Received:	January 26, 2009
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00829283 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Experimental
Comparator

Study placed in the following topic categories:

Obesity
Signs and Symptoms, Digestive
Psychotropic Drugs
Overweight
Hyperphagia
Sibutramine
Body Weight
Anti-Obesity Agents
Bulimia Nervosa
Signs and Symptoms

Mental Disorders
Weight Loss
Bulimia
Body Weight Changes
Appetite Depressants
Nutrition Disorders
Overnutrition
Antidepressive Agents
Eating Disorders

Additional relevant MeSH terms:

Obesity
Signs and Symptoms, Digestive
Psychotropic Drugs
Overweight
Pharmacologic Actions
Hyperphagia
Sibutramine
Body Weight
Anti-Obesity Agents
Bulimia Nervosa
Signs and Symptoms

Mental Disorders
Therapeutic Uses
Bulimia
Weight Loss
Body Weight Changes
Appetite Depressants
Nutrition Disorders
Overnutrition
Central Nervous System Agents
Antidepressive Agents
Eating Disorders

ClinicalTrials.gov processed this record on September 10, 2009