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| ID | Type | Description | Link |
|---|---|---|---|
| U01HL087071 | U.S. NIH Grant/Contract | View source | |
| U01HL087071-01 | U.S. NIH Grant/Contract | View source | |
| RFA-HL-007 |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Participants in this group will receive usual medical care and reading materials on weight loss. |
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| 2 | Experimental | Participants in this group will take part in the lifestyle modification program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Modification Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body mass index (BMI) | Measured at Year 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in blood pressure | Measured at Year 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23733374 | Derived | Ritzwoller DP, Glasgow RE, Sukhanova AY, Bennett GG, Warner ET, Greaney ML, Askew S, Goldman J, Emmons KM, Colditz GA; Be Fit Be Well study investigators. Economic analyses of the Be Fit Be Well program: a weight loss program for community health centers. J Gen Intern Med. 2013 Dec;28(12):1581-8. doi: 10.1007/s11606-013-2492-3. Epub 2013 Jun 4. | |
| 23496916 | Derived | Warner ET, Glasgow RE, Emmons KM, Bennett GG, Askew S, Rosner B, Colditz GA. Recruitment and retention of participants in a pragmatic randomized intervention trial at three community health clinics: results and lessons learned. BMC Public Health. 2013 Mar 6;13:192. doi: 10.1186/1471-2458-13-192. |
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| Usual Care and Reading Materials | Behavioral | 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. |
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| 22412073 | Derived | Bennett GG, Warner ET, Glasgow RE, Askew S, Goldman J, Ritzwoller DP, Emmons KM, Rosner BA, Colditz GA; Be Fit, Be Well Study Investigators. Obesity treatment for socioeconomically disadvantaged patients in primary care practice. Arch Intern Med. 2012 Apr 9;172(7):565-74. doi: 10.1001/archinternmed.2012.1. Epub 2012 Mar 12. |
| 20573639 | Derived | Yeh HC, Clark JM, Emmons KE, Moore RH, Bennett GG, Warner ET, Sarwer DB, Jerome GJ, Miller ER, Volger S, Louis TA, Wells B, Wadden TA, Colditz GA, Appel LJ. Independent but coordinated trials: insights from the practice-based Opportunities for Weight Reduction Trials Collaborative Research Group. Clin Trials. 2010 Aug;7(4):322-32. doi: 10.1177/1740774510374213. Epub 2010 Jun 23. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D006973 | Hypertension |
| D009043 | Motor Activity |
| D010349 | Patient Compliance |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
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