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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:
ClinicalTrials.gov Identifier:
NCT00516919
First Posted: August 16, 2007
Last Update Posted: February 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Donaghue Medical Research Foundation
Information provided by (Responsible Party):
Carlos Grilo, Yale University
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (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 Carlos Grilo, 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 15, 2007
First Posted: August 16, 2007
Results First Submitted: July 31, 2012
Results First Posted: February 7, 2013
Last Update Posted: February 7, 2013
Last Verified: January 2013

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

Additional relevant MeSH terms:
Obesity
Weight Loss
Binge-Eating Disorder
Bulimia
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Feeding and Eating Disorders
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents