Effectiveness of Brief Counseling for Weight Management

National Institutes of Health (NIH)

Status and phase

Completed

Phase 4

Conditions

1. Obesity

Treatments

Behavioral: Brief cognitive behavioral counseling

Drug: orlistat

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT00212199

DK58299 (completed 2205)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

25 to 55 years old

Volunteers

Accepts Healthy Volunteers

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