Abstract
BackgroundPoorly 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) for blood pressure (BP) reduction, the effectiveness of these approaches in primary care practices remains untested, especially among African Americans, who share a disproportionately greater burden of HTN-related outcomes.Methods/DesignThis 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 (UC) 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 (MINT) sessions (maintenance phase). The intervention is delivered by trained research personnel with appropriate treatment fidelity procedures. Patients in the UC 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 BP from baseline to 6 months. In addition to BP 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 RegistrationClinicaltrials.gov NCT01070056
Highlights
Introduction to medications for HTNMyths and Facts about HTN medications, tips for taking charge of medications, and understanding medication labels
The motivational interviewing (MINT)-therapeutic lifestyle changes (TLC) intervention is based on established clinical practice guidelines for prevention and treatment of HTN, which recommends weight loss, limiting sodium and alcohol intake, regular physical activity, and eating a low-fat diet that is rich in fruit and vegetables
Study Implementation: Challenges and Lessons Learned In the first few months of implementing the study, we encountered several “real world barriers” that have made us reevaluate the suitability of the TLC-Clinic protocol as originally conceived
Summary
Study Implementation: Challenges and Lessons Learned In the first few months of implementing the study, we encountered several “real world barriers” that have made us reevaluate the suitability of the TLC-Clinic protocol as originally conceived. We have adopted several strategies to facilitate high participation rates, including offering classes in the clinic; determining a cohort’s class schedule based on the most frequently selected time and date chosen by patients during the eligibility screen visit; and offering Saturday classes and make-up classes on an alternate day and time. Despite these efforts, approximately 50% of patients attend the weekly group classes, of which 35% have attended 9 to 10 of the classes (total of 10 classes).
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