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

This study has been completed.
Sponsor:
Collaborator:
Donaghue Medical Research Foundation
Information provided by (Responsible Party):
Carlos Grilo, Yale University
ClinicalTrials.gov Identifier:
NCT00516919
First received: August 15, 2007
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  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 4

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
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:

Drug Information available for: Orlistat
U.S. FDA Resources

Further study details as provided by Yale University:

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

  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 by Yale University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Carlos Grilo, Professor of Psychiatry and Psychology, Yale University
ClinicalTrials.gov 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
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:
Bulimia
Binge-Eating Disorder
Obesity
Weight Loss
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Body Weight Changes
Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013