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

Yale University

Status and phase: Completed; Phase 4

Conditions: Binge Eating; Obesity

Treatments: Drug: Xenical + behavioral intervention; Behavioral: Behavioral intervention + placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00516919

0608001753

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pregnancy
• Current cardiac disease
• Serious neurologic illnesses

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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79 participants in 2 patient groups

1

Experimental group

Description:

Xenical + behavioral intervention

Treatment:

Drug: Xenical + behavioral intervention

2

Active Comparator group

Description:

Placebo + behavioral intervention

Treatment:

Behavioral: Behavioral intervention + placebo