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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829283
• Other study ID #: 0610001922
• Secondary ID: R01DK049587
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: November 2013

Study information

• Verified date: April 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge Eating
• Binge-Eating Disorder
• Bulimia
• Obesity
• Weight Loss

Intervention

Behavioral:
• 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

Drug:
• Placebo
One pill daily
• Sibutramine/Orlistat
Sibutramine 15 mg daily or Orlistat 120mg TID

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Who Reached Binge Eating Remission	Binge Remission (abstinence from binge eating)	12 months follow-up
Secondary	BMI	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.	12 months follow-up post-treatment