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OpenTrials
Completed

NCT Number: NCT00212199

Effectiveness of Brief Counseling for Weight Management

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.

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Key information

Conditions

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orlistat

Drug

Brief cognitive behavioral counseling

Behavioral

Primary outcomes

  1. 1. Changes in body weight at 6, 12 and 24 months.

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

Secondary outcomes

  1. 1. Changes in blood pressure at 6, 12 and 24 months.

  2. 2. Changes in lipids at 6, 12 and 24 months.

  3. 3. Changes in serum glucose at 6, 12 and 24 months.

Sponsors and collaborators

Lead sponsor

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

Nih

Collaborators

  • Hoffmann-La Roche

Registry information

Important dates

Study start
2002
Study completion
2004
First posted
Sep 21, 2005
Registry last updated
Mar 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.