NCT00829283

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity
• Binge Eating

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-11-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2009-01-27
• Last updated: 2020-04-03
• Results posted: 2016-02-01

Locations

1 site across 1 country: United States