Study of Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons - Full Text View

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

This study is currently recruiting participants.
Verified by Yale University, April 2008

Sponsors and Collaborators:	Yale University 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

MedlinePlus related topics:

Obesity Weight Control

ChemIDplus related topics:

Orlistat

U.S. FDA Resources

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

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

Contacts


Contact: Luis M Anez, PsyD	203-789-7812	Luis.Aneznava@yale.edu

Contact: Manuel Paris, PsyD	203-789-7812	Manuel.Paris@yale.edu

Locations


United States, Connecticut
	Hispanic Clinic of the Connecticut Mental Health Center	Recruiting
	New Haven, Connecticut, United States, 06511
	Contact: Luis M Anez, PsyD 203-789-7812
	Contact: Manuel Paris, PsyD 203-789-7812
	Sub-Investigator: Luis M Anez, PsyD
	Sub-Investigator: Manuel Paris, PsyD
	Yale Department of Psychiatry	Recruiting
	New Haven, Connecticut, United States, 06519
	Principal Investigator: Carlos M Grilo, PhD
	Sub-Investigator: Marney A White, PhD

Sponsors and Collaborators

Yale University

Donaghue Medical Research Foundation

Investigators


Principal Investigator:	Carlos M Grilo, PhD	Yale University

More Information

Responsible Party:	Yale University School of Medicine ( Carlos M. Grilo, PhD )
Study ID Numbers:	DF-06-018
First Received:	August 15, 2007
Last Updated:	April 24, 2008
ClinicalTrials.gov Identifier:	NCT00516919
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

Obesity

Binge Eating

Monolingual Hispanic Persons

Orlistat

Behavioral Weight Loss Treatment

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Orlistat

Signs and Symptoms, Digestive

Bulimia

Weight Loss

Body Weight Changes

Nutrition Disorders

Overweight

Overnutrition

Hyperphagia

Additional relevant MeSH terms:

Anti-Obesity Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Enzyme Inhibitors

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008