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

Information source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity; Binge Eating

Intervention: Behavioral Weight Loss (Behavioral); Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy (Behavioral); Placebo (Drug); Sibutramine (Drug)

Phase: N/A

Status: Recruiting

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

Summary

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.

Clinical Details

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Factorial Assignment, Efficacy Study

Primary outcome: Binge Eating

Secondary outcome: BMI

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Yale School of Medicine, New Haven, Connecticut 06520, United States; Recruiting
Kerstin Blomquist, Ph.D., Phone: 203-737-5537, Email: kerstin.blomquist@yale.edu
Robin M Masheb, Ph.D., Phone: 203-785-7807, Email: robin.masheb@yale.edu
Robin M Masheb, Ph.D., Sub-Investigator
Marney White, Ph.D., Sub-Investigator
Carlos M Grilo, Ph.D., Principal Investigator
Additional Information

Starting date: November 2008
Ending date: May 2013
Last updated: July 7, 2009

Page last updated: October 19, 2009

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