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

Not Applicable

Completed

• Conditions: Binge Eating; Obesity
• Interventions: Behavioral: Behavioral Weight Loss; Behavioral: Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy; Drug: Placebo; Drug: Sibutramine/Orlistat

• Registration Number: NCT00829283
• Lead Sponsor: Yale University

Brief 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.

Detailed Description

The stepped-care arm of this study included an obesity medication intervention. At the start of the study, the active medication was sibutramine and was compared to a placebo control. On 10/8/2010, Abbott Laboratories withdrew their obesity drug sibutramine (Meridia) from the market in light of clinical trial data pointing to an increased risk for stroke and myocardial infarction. In response to this event, the investigators submitted an IRB amendment to change the active obesity medication from sibutramine to Orlistat. The IRB amendment was approved on 11/4/2010. The PI received approval from NIH/NIDDK Program Officer Robert Kuczmarski to enact this change.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Results First Submitted: 2015-10-27
• Results First Submitted QC: 2015-12-28
• Results First Posted: 2016-02-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
2	Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy	Stepped-care
1	Behavioral Weight Loss	Standard Care
2	Behavioral Weight Loss	Stepped-care
2	Sibutramine/Orlistat	Stepped-care
2	Placebo	Stepped-care

Primary Outcome Measures

Name	Time	Method
Number of Subjects Who Reached Binge Eating Remission	12 months follow-up	Binge Remission (abstinence from binge eating)

Secondary Outcome Measures

Name	Time	Method
BMI	12 months follow-up post-treatment	The body mass index is a value derived from the mass and height of an individual. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m\^2.

Trial Locations

Locations (1)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States