Study of Five Different Methods Of Delivering A Lifestyle Modification Program for Weight Loss
NCT00471172
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- 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
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Study of Five Different Methods Of Delivering A Lifestyle Modification Program for Weight Loss | |||
Official Title ICMJE | A 6-Month, Randomized Study To Evaluate The Efficacy Of Various Non-Pharmacologic, Disease Management Programs For The Treatment Of Obesity | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) | |||
Condition ICMJE | Obesity | |||
Intervention ICMJE |
| |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 350 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 25 Years to 60 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00471172 | |||
Other Study ID Numbers ICMJE | A9001187 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | September 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |