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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 high blood pressure, and obesity is likely a contributing factor for both conditions. African-Americans, in particular, experience an earlier onset of high blood pressure and suffer more severe health consequences as a result, than do other racial and ethnic groups. This study will evaluate the effectiveness of a lifestyle modification program that will focus on reducing blood pressure levels and encouraging weight loss among patients at community health centers that serve a primarily low-income, ethnically diverse population. Researchers will also evaluate the cost effectiveness of the lifestyle modification program. This 2-year study will enroll people who have high blood pressure. Participants will attend a baseline study visit to complete health questionnaires. They will then be randomly assigned to either receive usual care along with printed materials about maintaining a healthy weight or take part in the lifestyle modification program that incorporates health information technologies. Participants assigned to the program will visit the BFBW study Web site several times a week to review educational and motivational information. They may receive automated weekly phone calls that will prompt them to answer questions and assist them in setting goals for losing weight and managing their blood pressure. A study researcher will call participants every 6 weeks to discuss any problems and to invite participants to take part in optional walking groups or other group activities. Participants will attend group support sessions every other month and will wear a pedometer to track their walking habits. For all participants, study visits will occur at baseline and Months 6, 12, 18, and 24. All visits will include weight and blood pressure measurements, health questionnaires, and physician referrals if needed.

Official Title
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Integrated Weight Loss Technologies for Weight and Blood Pressure Control in Urban Clinics

Conditions
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Obesity, Hypertension

Intervention / Treatment
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* Behavioral: Lifestyle Modification Program
* Behavioral: Usual Care and Reading Materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Participants in this group will receive usual medical care and reading materials on weight loss. | Behavioral: Usual Care and Reading Materials<br>* Participants in this group will receive usual medical care provided by their own primary care providers. They will also receive the NHLBI's Aim for a Healthy Weight brochure at the baseline study visit and again at the beginning of Year 2.<br>|
| Experimental: 2<br>Participants in this group will take part in the lifestyle modification program. | Behavioral: Lifestyle Modification Program<br>* Participants will receive a behavior change prescription and skills training, offered via the Internet or through a combination of tailored print materials and an interactive voice response system, together with support strategies to enhance the intensity of the interpersonal and social-environmental support.<br>* Other names: ES+SS (Environmental Support + Social Support);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass index (BMI) |  | Measured at Year 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in blood pressure |  | Measured at Year 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Physical Fitness, Patient Compliance, Health Behavior