Practice-based Trial of Blood Pressure Control in African Americans
Practice-based Trial of Blood Pressure Control in African Americans
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.
Inclusion Criteria:

 -  Age 18 years or older

 -  Receiving care within the NYU Ambulatory Care Network for at least one year.

 -  Patient must have uncontrolled HTN defined as an average SBP≥140 mmHg or DBP≥90 mmHg
 (SBP≥130 mmHg or DBP≥80 mmHg for patients with diabetes or chronic kidney disease) on
 at least two previous visits in the past year

 -  English speaking

 -  Self-identify as Black, or African American;

 -  Permission by patient's physician to participate in the study.

 -  CARE-DIAG score < 6 (participants age 60 and older only)

 Exclusion Criteria:

 -  Being deemed unable to comply with the study protocol (either self-selected or by
 indicating during screening that s/he could not complete all requested tasks including
 attend intervention classes if he/she were to be randomized to the intervention
 group).

 -  Participation in other clinical trials.

 -  Diagnosis of cognitive dysfunction or significant psychiatric comorbidity (as
 indicated in medical record).

 -  Blood pressure reading ≥ 180/110 at initial screening/baseline visit

 -  Pregnant