Study of Five Different Methods Of Delivering A Lifestyle Modification Program for Weight Loss
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00471172
First received: May 7, 2007
Last updated: September 12, 2008
Last verified: September 2008
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Purpose
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 |
|---|---|
|
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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | A 6-Month, Randomized Study To Evaluate The Efficacy Of Various Non-Pharmacologic, Disease Management Programs For The Treatment Of Obesity |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Percentage change in body weight at 6 months.
Secondary Outcome Measures:
- Changes in waist circumference, lipids, glucose, insulin, blood pressure, quality of life and weight-related symptoms at 6 months.
| Estimated Enrollment: | 350 |
| Study Start Date: | August 2004 |
| Study Completion Date: | May 2005 |
Eligibility| Ages Eligible for Study: | 25 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 1- Body mass index -calculated as weight in kilograms divided by the square of height in meters- ≥30 and <40 kg/m2.
- 2- Eligibility to be prescribed sibutramine, following the eligibility requirements listed in the US Package Insert
- 3- Willingness and ability to comply with study related procedures
- 4- Access to Internet and email
Exclusion Criteria:
- Uncontrolled blood pressure (defined as ≥140/90 mmHg), diabetes, coronary heart disease, chronic congestive heart failure, stroke, significant metabolic, hepatic or renal disease, current malignancy, gastric bypass surgery or had a weight loss ≥10%, participated in a structured weight loss program, or had taken weight loss agents during the past 6 months. Women were excluded if pregnant or breastfeeding; women of childbearing potential had to use adequate contraception.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471172
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471172
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Clearwater, Florida, United States | |
| Pfizer Investigational Site | |
| Kissimmee, Florida, United States | |
| Pfizer Investigational Site | |
| Pembroke Pines, Florida, United States | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Lexington, Kentucky, United States | |
| Pfizer Investigational Site | |
| Louisville, 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 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00471172 History of Changes |
| Other Study ID Numbers: | A9001187 |
| Study First Received: | May 7, 2007 |
| Last Updated: | September 12, 2008 |
| Health Authority: | Unknown: |
ClinicalTrials.gov processed this record on March 01, 2015