Status:
COMPLETED
Evaluating a Blood Pressure Reduction and Weight Loss Program in a Low Income, Ethnically Diverse Population (The Be Fit, Be Well [BFBW] Study)
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Obesity
Hypertension
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Obesity is a serious health problem that is a contributing factor for heart disease and high blood pressure. This study will evaluate a lifestyle modification program that aims to encourage weight los...
Detailed Description
Obesity is a serious health problem in the United States, particularly among lower income and racial and ethnic minority populations. These populations have a high risk of developing heart disease and...
Eligibility Criteria
Inclusion
- High blood pressure that is being treated with medication
- BMI between 30 and 50 kg/m2
- Weighs no more than 400 lbs
- Willing to change diet, physical activity levels, and weight
- Willing to be assigned to either study group
- Patient of a participating community health center with a record of at least one medical visit in the 12 months before study entry
- Primary care provider approval is needed for people with the following conditions: diabetes mellitus, a prior cardiovascular event more than 6 months before study entry, known stable cardiovascular or peripheral vascular disease
Exclusion
- Experienced a heart attack, stroke, or an atherosclerotic cardiovascular disease (ASCVD) procedure in the 6 months before study entry
- Serious medical condition that is likely to interfere with an accurate measurement of weight, for which weight loss is not medically advisable, or that would cause weight loss (e.g., end-stage renal disease \[ESRD\] and on dialysis; diagnosis or treatment for cancer in the 2 years before study entry, other than non-melanoma skin cancer)
- Prior or planned bariatric surgery
- Use of FDA-approved prescription weight loss medication, including off label drugs (e.g., topiramate, bupropion, byetta) or over-the-counter orlistat in the 6 months before study entry
- Long-term use (i.e., in the 6 months before study entry) of medications likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine)
- Pregnant or breastfeeding in the 6 months before study entry
- Plans to become pregnant in the 2 years after study entry
- Plans to relocate from the area in the 2 years after study entry
- Another member of household is a study participant or study staff member
- Principal investigator decides that the individual is not suitable for the study
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
365 Patients enrolled
Trial Details
Trial ID
NCT00661817
Start Date
November 1 2006
End Date
April 1 2011
Last Update
March 6 2012
Active Locations (1)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115