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Study of Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons
This study is ongoing, but not recruiting participants.
First Received: August 15, 2007   Last Updated: January 13, 2010   History of Changes
Sponsor: Yale University
Collaborator: Donaghue Medical Research Foundation
Information provided by: Yale University
ClinicalTrials.gov Identifier: NCT00516919
  Purpose

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.


Condition Intervention Phase
Obesity
Binge Eating
Drug: Xenical + behavioral intervention
Behavioral: Behavioral intervention + placebo
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Controlled Trial of Orlistat With Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Body weight / BMI [ Time Frame: 4 months and 6 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: August 2007
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Xenical + behavioral intervention
Drug: Xenical + behavioral intervention
120 mg TID; Behavioral weight loss in Spanish
2: Active Comparator
Placebo + behavioral intervention
Behavioral: Behavioral intervention + placebo
Behavioral weight loss treatment in Spanish Placebo TID

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Current cardiac disease
  • Serious neurologic illnesses
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516919

Locations
United States, Connecticut
Hispanic Clinic of the Connecticut Mental Health Center
New Haven, Connecticut, United States, 06511
Yale Department of Psychiatry
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Donaghue Medical Research Foundation
Investigators
Principal Investigator: Carlos M Grilo, PhD Yale University
  More Information

No publications provided

Responsible Party: Yale University School of Medicine ( Carlos M. Grilo, PhD )
Study ID Numbers: DF-06-018
Study First Received: August 15, 2007
Last Updated: January 13, 2010
ClinicalTrials.gov Identifier: NCT00516919     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Obesity
Binge Eating
Monolingual Hispanic Persons
Orlistat
Behavioral Weight Loss Treatment

Additional relevant MeSH terms:
Obesity
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Enzyme Inhibitors
Overweight
Pharmacologic Actions
Hyperphagia
Body Weight
Anti-Obesity Agents
Bulimia Nervosa
Signs and Symptoms
Orlistat
Mental Disorders
Therapeutic Uses
Bulimia
Weight Loss
Body Weight Changes
Nutrition Disorders
Overnutrition
Central Nervous System Agents
Eating Disorders

ClinicalTrials.gov processed this record on February 08, 2010