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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00471172 |
The aim of the study was to compare 5 methods of delivering a weight loss lifestyle modification program to obese patients on a background of sibutramine. The methods differed in the type and frequency of counseling utilized to deliver dietary, physical activity and behavioral recommendations for weight loss.
Condition | Intervention |
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Obesity |
Behavioral: Face-to-face counseling by a dietitian (months 1-3: weekly, months 4-6: every other week) Behavioral: Face-to-face counseling by a dietitian (monthly) Behavioral: Counseling by a dietitian via telephone (months 1-3: weekly, months 4-6: every other week) Behavioral: Counseling by a dietitian via e-mail (months 1-3: weekly, months 4-6: every other week) Behavioral: Self help |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | A 6-Month, Randomized Study To Evaluate The Efficacy Of Various Non-Pharmacologic, Disease Management Programs For The Treatment Of Obesity |
Estimated Enrollment: | 350 |
Study Start Date: | August 2004 |
Study Completion Date: | May 2005 |
Ages Eligible for Study: | 25 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Pfizer Investigational Site | |
Los Angeles, California, United States | |
United States, Florida | |
Pfizer Investigational Site | |
Pembroke Pines, Florida, United States | |
Pfizer Investigational Site | |
Kissimmee, Florida, United States | |
Pfizer Investigational Site | |
Clearwater, Florida, United States | |
United States, Kentucky | |
Pfizer Investigational Site | |
Louisville, Kentucky, United States | |
Pfizer Investigational Site | |
Lexington, Kentucky, United States | |
United States, Massachusetts | |
Pfizer Investigational Site | |
Milford, Massachusetts, United States | |
United States, North Carolina | |
Pfizer Investigational Site | |
Charlotte, North Carolina, United States | |
United States, Pennsylvania | |
Pfizer Investigational Site | |
Harleysville, Pennsylvania, United States | |
United States, Rhode Island | |
Pfizer Investigational Site | |
Warwick, Rhode Island, United States | |
United States, Tennessee | |
Pfizer Investigational Site | |
Nashville, Tennessee, United States | |
United States, Wisconsin | |
Pfizer Investigational Site | |
Milwaukee, Wisconsin, United States |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Study ID Numbers: | A9001187 |
Study First Received: | May 7, 2007 |
Last Updated: | September 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00471172 History of Changes |
Health Authority: | Unknown: |
Body Weight Signs and Symptoms Obesity Weight Loss |
Nutrition Disorders Overweight Overnutrition |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |