Effectiveness of Brief Counseling for Weight Management

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00212199
First received: September 13, 2005
Last updated: March 17, 2010
Last verified: March 2010
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

ClinicalTrials.gov processed this record on September 30, 2014