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OpenTrials
Completed

NCT Number: NCT00516919

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy
  • Current cardiac disease
  • Serious neurologic illnesses

Treatment and study plan

Xenical + behavioral intervention

Drug

120 mg TID; Behavioral weight loss in Spanish

Other names: Xenical

Behavioral intervention + placebo

Behavioral

Behavioral weight loss treatment in Spanish Placebo TID

Primary outcomes

  1. Participant BMI

    Time frame: 4 months and 6 month follow-up

    Body Mass Index (BMI)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Donaghue Medical Research Foundation

Registry information

Official study title

Controlled Trial of Orlistat With Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 16, 2007
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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