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:

MedlinePlus related topics: Obesity Weight Control

Drug Information available for: Orlistat

U.S. FDA Resources

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