Background:
Poorly controlled hypertension 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 for blood pressure reduction, the effectiveness of these approaches in primary care practices remains untested, especially among African Americans, who share a disproportionately greater burden of hypertension-related outcomes.
Methods:
This randomized controlled trial tests the effectiveness of a practice-based comprehensive therapeutic lifestyle intervention, delivered through group-based counseling and motivational interviewing (MINT-TLC) versus usual care in 200 low-income, African Americans with uncontrolled hypertension. MINT-TLC is designed to help patients make appropriate lifestyle changes and develop skills to maintain these changes long-term. Patients in the MINT-TLC group attend 10 weekly group classes focused on healthy lifestyle changes (intensive phase); followed by 3 monthly individual motivational interviewing sessions (maintenance phase). The intervention is delivered by trained research personnel with appropriate treatment fidelity procedures. Patients in the usual care condition receive a single individual counseling session on healthy lifestyle changes 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. In addition to blood pressure control at 6 months, other secondary outcomes include changes in the following lifestyle behaviors from baseline to 6 months: a) physical activity, b) weight loss, c) number of daily servings of fruits and vegetables and d) 24-hour urinary sodium excretion.DiscussionThis vanguard trial will provide information on how to refine MINT-TLC and integrate it into a standard treatment protocol for hypertensive African Americans as a result of the data obtained; thus maximizing the likelihood of its translation into clinical practice.Trial Registration: Clinicaltrials.gov NCT01070056