Evaluating a Blood Pressure Reduction and Weight Loss Program in a Low Income, Ethnically Diverse Population (The Be Fit, Be Well [BFBW] Study)

Completed · Not applicable

Conditions studied: Obesity, Hypertension

In brief

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 loss and improve the health of people with high blood pressure from low income and minority communities.

Key facts

Study ID

NCT00661817

Run by

Washington University School of Medicine

People needed

365

Starts

2006-11-01

Expected to finish

2011-04-01

Last updated by the study team

2012-03-06

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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