Effectiveness of Brief Counseling for Weight Management

NCT ID: NCT00212199

Last Updated: 2010-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2004-08-31

Brief Summary

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.

Detailed Description

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.

Conditions

1. Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

orlistat

Intervention Type: DRUG

Brief cognitive behavioral counseling

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: lead

Principal Investigators

John P Foreyt, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

DK58299 (completed 2205)

Identifier Type: -

Identifier Source: org_study_id