Study of Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons

Verified by: Yale University, January 2010
First Received: August 15, 2007 | Last Updated: January 13, 2010 | Phase: Phase 4 | Start Date: August 2007
Overall Status: Active, not recruiting | Estimated Enrollment: 80
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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...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • 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

Outcome Measures for this Clinical Trial

Primary Measures

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Yale University Other

Overall Clinical Trial Officials and Contacts

Carlos M Grilo, PhD Principal Investigator Yale University  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00516919