Practice-based Trial of Blood Pressure Control in African Americans

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Practice-based Trial of Blood Pressure Control in African Americans

Conditions
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Hypertension, Physical Activity, Diet, Medication Adherence

Intervention / Treatment
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* Behavioral: Therapeutic Lifestyle Changes (MINT-TLC)
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Patients randomized to the Usual Care (UC) condition will receive standard hypertension (HTN) treatment recommendations as determined by their physicians. In addition, they will receive a 30-minute individual counseling session on therapeutic lifestyle modification, similar to PREMIER. We feel obligated ethically to provide this minimal intervention to patients in the UC group given that counseling on TLC is a standard recommendation for treatment of hypertension. To match the MINT-TLC group for content of intervention material, those in the UC group will receive print versions of the intervention materials. | Behavioral: Usual Care<br>* Patients randomized to the Usual Care (UC) condition will receive standard hypertension (HTN) treatment recommendations as determined by their physicians. In addition, they will receive a 30-minute individual counseling session on therapeutic lifestyle modification, similar to PREMIER. We feel obligated ethically to provide this minimal intervention to patients in the UC group given that counseling on TLC is a standard recommendation for treatment of hypertension. To match the MINT-TLC group for content of intervention material, those in the UC group will receive print versions of the intervention materials.<br>|
| Experimental: Therapeutic Lifestyle Changes (MINT-TLC)<br>This intervention is based on established clinical practice guidelines for prevention and treatment of hypertension (HTN), which recommends weight loss (if overweight), limiting sodium and alcohol intake, regular physical activity, reducing alcohol intake, and eating a low-fat diet that is rich in fruit and vegetables. MINT-TLC will be conducted by trained research personnel. Patients will attend 10 classes over 12 weeks (intensive phase) followed by individual monthly MINT sessions for 3 months (maintenance phase). We chose the intervention schedules to pattern after the methodology of therapeutic lifestyle interventions with proven efficacy in hypertensive patients, specifically, Trial of Nonpharmacologic Approaches in Elderly Hypertensives (TONE) and PREMIER trials. | Behavioral: Therapeutic Lifestyle Changes (MINT-TLC)<br>* This intervention is based on established clinical practice guidelines for prevention and treatment of hypertension(HTN), which recommends weight loss (if overweight), limiting sodium and alcohol intake, regular physical activity, reducing alcohol intake, and eating a low-fat diet that is rich in fruit and vegetables. MINT-TLC will be conducted by trained research personnel. Patients will attend 10 classes over 12 weeks (intensive phase) followed by individual monthly MINT sessions for 3 months (maintenance phase). We chose the intervention schedules to pattern after the methodology of therapeutic lifestyle interventions with proven efficacy in hypertensive patients, specifically, Trial of Nonpharmacologic Approaches in Elderly Hypertensives (TONE) and PREMIER trials.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is within-patient change in systolic (SBP) and diastolic (DBP) from baseline to 6 months. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Pressure, Lifestyle Changes, African American