Evaluating a Blood Pressure Reduction and Weight Loss Program in a Low Income, Ethnically Diverse Population (The Be Fit, Be Well [BFBW] Study) (BFBW)
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|ClinicalTrials.gov Identifier: NCT00661817|
Recruitment Status : Completed
First Posted : April 18, 2008
Last Update Posted : March 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Obesity Hypertension||Behavioral: Lifestyle Modification Program Behavioral: Usual Care and Reading Materials||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||365 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Integrated Weight Loss Technologies for Weight and Blood Pressure Control in Urban Clinics|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Active Comparator: 1
Participants in this group will receive usual medical care and reading materials on weight loss.
Behavioral: Usual Care and Reading Materials
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.
Participants in this group will take part in the lifestyle modification program.
Behavioral: Lifestyle Modification Program
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.
Other Name: ES+SS (Environmental Support + Social Support)
- Change in body mass index (BMI) [ Time Frame: Measured at Year 2 ]
- Reduction in blood pressure [ Time Frame: Measured at Year 2 ]
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): NCT00661817
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Graham A. Colditz, MD, DrPH||Washington University School of Medicine|
|Principal Investigator:||Gary G. Bennett, PhD||Dana Farber Cancer Institute/Harvard School of Public Health|
|Principal Investigator:||Karen M. Emmons, PhD||Dana Farber Cancer Institute/Harvard School of Public Health|