Effectiveness of Brief Counseling for Weight Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Brief Counseling for Weight Management

Conditions
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1. Obesity

Intervention / Treatment
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* Drug: orlistat
* Behavioral: Brief cognitive behavioral counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: orlistat|nan|
|Behavioral: Brief cognitive behavioral counseling|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity Treatment, Effectiveness of weight management treatment, Counseling for weight management