Official Title: “Controlled Trial of Orlistat With Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons”

This is a research study designed to examine the effectiveness of an obesity medication (orlistat) given in addition to behavioral weight loss therapy. Participants will be obese monolingual (Spanish-speaking only) men and women.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2010

Intervention(s) in this Clinical Trial

• Drug: Xenical + behavioral intervention
  • 120 mg TID; Behavioral weight loss in Spanish
• Behavioral: Behavioral intervention + placebo
  • Behavioral weight loss treatment in Spanish Placebo TID

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Xenical + behavioral intervention
• Active Comparator: 2
  • Placebo + behavioral intervention

Primary Measures

• Body weight / BMI
  • Time Frame: 4 months and 6 month follow-up
    Safety Issue?: No

Inclusion Criteria:

• Monolingual Spanish Speaking
• Obese (BMI >= 30)

Exclusion Criteria:

• Pregnancy
• Current cardiac disease
• Serious neurologic illnesses

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Yale University

Overall Clinical Trial Officials and Contacts

Carlos M Grilo, PhD Principal Investigator Yale University  

Overall Contact: Luis M Anez, PsyD 203-789-7812 Luis.Aneznava@yale.edu

Information obtained from ClinicalTrials.gov on January 09, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00516919

Study ID Number: DF-06-018

ClinicalTrials.gov Identifier: NCT00516919

Health Authority: United States: Institutional Review Board