Practice-based Trial of Blood Pressure Control in African Americans
| Status: | Archived |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | February 2010 |
| End Date: | March 2013 |
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 200 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 12 weeks
(intensive phase); followed by individual motivational interviewing (MINT) sessions for 3
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 blood
pressure from baseline to 6 months. Secondary outcomes are levels of targeted therapeutic
lifestyle behaviors; and proportion of patients with adequate blood pressure control at 6
months
We will test the effectiveness of a primary care practice-based comprehensive therapeutic
lifestyle intervention, delivered through group-based counseling and motivational
interviewing (MINT-TLC) in a two-arm, randomized controlled trial (RCT) in 200 low-income,
poorly controlled hypertensive African-American patients. MINT is a directive,
participant-centered, counseling approach for initiating and maintaining behavior change
that has proven effective in improving adherence to various health behaviors. We
hypothesize that among African Americans with poorly controlled hypertension (HTN), those
randomized to TLC group, compared to those randomized to UC, will exhibit a greater
reduction in systolic and diastolic blood pressure (BP); greater levels of physical
activity; percent change in weight; increased intake of fruits and vegetables; and reduced
24-hour urinary sodium excretion at 6 months.The primary outcome is within-patient change in
systolic (SBP) and diastolic (DBP) from baseline to 6 months. The secondary outcomes are the
levels of physical activity, percent change in weight, dietary intake of fruits and
vegetables, 24-hour urinary sodium excretion and BP control rates at 6 months. Blood
pressure will be assessed with a well-validated automated digital BP monitor (BPTru),
following American Heart Association guidelines. Therapeutic lifestyle behaviors will be
assessed with validated self-report measures: Dietary intake will be assessed with the NCI's
fruit/vegetable and fat brief dietary assessment questionnaires; and physical activity will
be assessed with the Nurses Health Study and Health Professionals Study's physical activity
questionnaire. Percent weight loss will be estimated from the difference in weight between
baseline and 6 months, while 24-hour urinary sodium excretion will be used to estimate
dietary sodium intake. Patients are categorized as having controlled BP if their average BP
that fulfills the Seventh Joint National Committee on Detection, Evaluation and Treatment of
Hypertension (JNC-7) criteria of SBP < 130 and DBP < 80 mmHg (patients with diabetes or
chronic kidney disease); or SBP < 140 and DBP < 90 mmHg (for all other patients). Regardless
of group assignments, all outcomes data will be assessed at baseline, 3 months, and 6
months.
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