Effectiveness of Brief Counseling for Weight Management (NCT00212199) | Clinical Trial Compass
CompletedPhase 4
Effectiveness of Brief Counseling for Weight Management
United States246 participantsStarted 2002-01
Plain-language 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.
Who can participate
Age range25 Years – 55 Years
SexALL
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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
What they're measuring
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.
Trial details
NCT IDNCT00212199
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)