Effectiveness of Brief Counseling for Weight Management

This study has been completed.

First Received on September 13, 2005. Last Updated on March 17, 2010 History of Changes

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator:	Hoffmann-La Roche
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00212199

Purpose

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.

Condition	Intervention	Phase
1. Obesity	Drug: orlistat Behavioral: Brief cognitive behavioral counseling	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effectiveness of Brief Counseling for Weight Management

Resource links provided by NLM:

MedlinePlus related topics: Obesity

Drug Information available for: Orlistat

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome 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 Outcome 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.

Estimated Enrollment:	246
Study Start Date:	January 2002
Study Completion Date:	August 2004

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.

Eligibility

Ages Eligible for Study:	25 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212199

Locations

United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030

Sponsors and Collaborators

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

Hoffmann-La Roche

Investigators

Principal Investigator:

John P Foreyt, PhD

Baylor College of Medicine

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00212199 History of Changes
Other Study ID Numbers:	DK58299 (completed 2205)
Study First Received:	September 13, 2005
Last Updated:	March 17, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Obesity Treatment
Effectiveness of weight management treatment
Counseling for weight management

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Orlistat

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012