Poorly controlled hypertension (HTN) remains one of the most significant public health problems in the United States, in terms of morbidity, mortality, and economic burden. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes (TLC) on blood pressure (BP) reduction, their effectiveness remains untested in primary care practices, especially among minority patients who share a greater burden of HTN-related outcomes including chronic kidney disease, stroke and heart failure. This randomized controlled trial offers a unique opportunity to address this gap in the literature. Among 500 hypertensive African-Americans who receive care in community- based primary care practices, we will test the effectiveness of a culturally-tailored comprehensive therapeutic lifestyle intervention, delivered through group-based counseling and motivational interviewing (MINT-TLC) vs. Usual Care (UC). MINT-TLC is designed to help patients make appropriate TLC and develop skills to maintain these changes long-term. Patients in the MINT-TLC group will attend weekly group classes focused on TLC for 10 weeks (intensive phase);followed by individual motivational interviewing (MINT) sessions for 2 months (extended phase);and then bi-monthly booster MINT sessions for 4 months (maintenance phase). Trained research personnel will deliver MINT-TLC with appropriate treatment fidelity procedures. Patients in the UC condition will receive a single individual counseling session on TLC and print versions of the intervention materials. The primary outcome is within-patient change in both systolic and diastolic BP from baseline to 12 months. Secondary outcomes are levels of targeted therapeutic lifestyle behaviors;and proportion of patients with adequate BP control at 12 months (BP The long-term goal is to refine MINT-TLC and integrate it into standard HTN treatment protocol as a result of the data obtained;thus maximizing the likelihood of its translation to clinical practice. Public Health Relevance: Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes or blood pressure reduction, the effectiveness of these approaches in primary care practices remains untested. We will test the effectiveness of a practice-based comprehensive therapeutic lifestyle intervention, delivered through group-based counseling and motivational interviewing in a two-arm, randomized controlled trial in 500 poorly- controlled hypertensive African-Americans, who receive care in community-based primary care practices.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
5R01HL087301-02
Application #
7936927
Study Section
Psychosocial Risk and Disease Prevention Study Section (PRDP)
Program Officer
Einhorn, Paula
Project Start
2009-09-30
Project End
2012-07-31
Budget Start
2010-08-01
Budget End
2012-07-31
Support Year
2
Fiscal Year
2010
Total Cost
$1,131,439
Indirect Cost
Name
New York University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
121911077
City
New York
State
NY
Country
United States
Zip Code
10016
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