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

This study has been completed.
Donaghue Medical Research Foundation
Information provided by (Responsible Party):
Carlos Grilo, Yale University Identifier:
First received: August 15, 2007
Last updated: January 7, 2013
Last verified: January 2013
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
Binge Eating
Drug: Xenical + behavioral intervention
Behavioral: Behavioral intervention + placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:
  • Participant BMI [ Time Frame: 4 months and 6 month follow-up ]
    Body Mass Index (BMI)

Enrollment: 79
Study Start Date: August 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Xenical + behavioral intervention
Drug: Xenical + behavioral intervention
120 mg TID; Behavioral weight loss in Spanish
Other Name: Xenical
Active Comparator: 2
Placebo + behavioral intervention
Behavioral: Behavioral intervention + placebo
Behavioral weight loss treatment in Spanish Placebo TID


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

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
Principal Investigator: Carlos M Grilo, PhD Yale University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Carlos Grilo, Professor of Psychiatry and Psychology, Yale University Identifier: NCT00516919     History of Changes
Other Study ID Numbers: DF-06-018
Study First Received: August 15, 2007
Results First Received: July 31, 2012
Last Updated: January 7, 2013

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

Additional relevant MeSH terms:
Weight Loss
Binge-Eating Disorder
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents processed this record on May 24, 2017