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 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 (Adult) |
| Sexes Eligible for Study: | All |
| 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.
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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:
| ClinicalTrials.gov Identifier: | NCT00471172 History of Changes |
| Other Study ID Numbers: |
A9001187 |
| Study First Received: | May 7, 2007 |
| Last Updated: | September 12, 2008 |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 24, 2017