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

Phase 4

Completed

• Conditions: Obesity; Binge Eating
• Interventions: Behavioral: Behavioral intervention + placebo; Drug: Xenical + behavioral intervention

• Registration Number: NCT00516919
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-15
• Study First Submitted QC: 2007-08-15
• Study First Posted: 2007-08-16
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2012-07-31
• Results First Submitted QC: 2013-01-07
• Results First Posted: 2013-02-07
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy
• Current cardiac disease
• Serious neurologic illnesses

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Behavioral intervention + placebo	Placebo + behavioral intervention
1	Xenical + behavioral intervention	Xenical + behavioral intervention

Primary Outcome Measures

Name	Time	Method
Participant BMI	4 months and 6 month follow-up	Body Mass Index (BMI)

Trial Locations

Locations (2)

Hispanic Clinic of the Connecticut Mental Health Center; 🇺🇸 New Haven, Connecticut, United States

Yale Department of Psychiatry; 🇺🇸 New Haven, Connecticut, United States