Effectiveness of Brief Counseling for Weight Management - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

December 14, 2007

Start Date ^ICMJE

January 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00212199 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Effectiveness of Brief Counseling for Weight Management

Official Title ^ICMJE

Effectiveness of Brief Counseling for Weight Management

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

1. Obesity

Intervention ^ICMJE

Drug: orlistat
Behavioral: Brief cognitive behavioral counseling

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

246

Completion Date

August 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

25 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00212199

Responsible Party

Study ID Numbers ^ICMJE

DK58299

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Hoffmann-La Roche

Investigators ^ICMJE

Principal Investigator:

John P Foreyt, PhD

Baylor College of Medicine

Information Provided By

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

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP