Study of Five Different Methods Of Delivering A Lifestyle Modification Program for Weight Loss
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| ClinicalTrials.gov Identifier: NCT00471172 |
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Recruitment Status :
Completed
First Posted : May 9, 2007
Last Update Posted : September 15, 2008
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Sponsor:
Pfizer
Information provided by:
Pfizer
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 350 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | August 2004 |
| Actual Study Completion Date : | May 2005 |
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.
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| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00471172 History of Changes |
| Other Study ID Numbers: |
A9001187 |
| First Posted: | May 9, 2007 Key Record Dates |
| Last Update Posted: | September 15, 2008 |
| Last Verified: | September 2008 |
Additional relevant MeSH terms:
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Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |