Official Title: “Effectiveness of Brief Counseling for Weight Management”

The purpose of this study is to test the effectiveness of three different methods for delivering weight management information. Two methods utilize an obesity drug and the third method utilizes brief behavioral counseling sessions only.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

There is a growing demand for effective obesity treatments that don't require much time to implement especially in a primary health-care setting where time is especially limited.

Brief interventions that might provide benefits similar to those produced by more time-intensive and costly lifestyle interventions would be very useful. There is also increasing interest in the efficacy of primary drug therapies for obesity. The purpose of this 12-month study, and 24-month follow-up, is to examine the efficacy of a brief behavioral counseling intervention alone or in combination with a drug already approved for the long-term management of obesity (orlisat)and compare both interventions to a drug alone condition.

Intervention(s) in this Clinical Trial

• Drug: orlistat
• Behavioral: Brief cognitive behavioral counseling

Primary Measures

• 1. Changes in body weight at 6, 12 and 24 months.
• 2. Changes in body mass index (BMI) at 6, 12 and 24 months.

Secondary Measures

• 1. Changes in blood pressure at 6, 12 and 24 months.
• 2. Changes in lipids at 6, 12 and 24 months.
• 3. Changes in serum glucose at 6, 12 and 24 months.

Inclusion Criteria:

• Body Mass Index of 30 to 40
• Male or females ages of 25 to 55 years
• Normal blood pressure or controlled with medicine
• Females not lactating, able to get pregnant or using acceptable birth control
• Current allowed medications prescribed at least 2 months prior to study

Exclusion Criteria:

• Pregnant, planning to get pregnant or becomes pregnant
• Insulin dependent diabetes
• Uncontrolled hypertension
• Prescence or history of significant medical conditions that could impact the outcome of the study
• Prescence of active gastrointestinal disorders
• History of mental disorders including eating disorders
• Weight loss greater than 10 pounds in the last 3 months
• History of alcohol or drug dependency
• Use of any weight-loss medication in the last 6 months
• Known allery to orlistat or any of its components

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 25 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Overall Clinical Trial Officials and Contacts

John P Foreyt, PhD Principal Investigator Baylor College of Medicine  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00212199

Study ID Number: DK58299

ClinicalTrials.gov Identifier: NCT00212199

Health Authority: United States: Federal Government