- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00212199
Effectiveness of Brief Counseling for Weight Management
March 17, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
246
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
1. Changes in body weight at 6, 12 and 24 months.
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2. Changes in body mass index (BMI) at 6, 12 and 24 months.
|
Secondary Outcome Measures
Outcome Measure |
---|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: John P Foreyt, PhD, Baylor College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2002
Study Completion (Actual)
August 1, 2004
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
March 18, 2010
Last Update Submitted That Met QC Criteria
March 17, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK58299 (completed 2205)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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