Effectiveness of Brief Counseling for Weight Management
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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 |
- 1. Changes in body weight at 6, 12 and 24 months.
- 2. Changes in body mass index (BMI) at 6, 12 and 24 months.
- 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 |
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 |
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| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| 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 May 23, 2013