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Abstract Background 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) 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/Design 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 (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. Discussion This 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

Background: Although the efficacy of therapeutic lifestyle change (TLC) interventions are well proven, their relative effectiveness vs. single-session lifestyle counseling (SSC) on blood pressure (BP) reduction in primary care practices remains largely untested in hypertensive Blacks. The aim of this trial was to evaluate the comparative effectiveness of a comprehensive practice-based TLC intervention (motivational interviewing (MINT)-TLC) vs. SSC on BP reduction among 194 Blacks with uncontrolled hypertension., Methods: The MINT-TLC arm included 10 weekly group classes on TLC, followed by 3 individual MINT sessions. The SSC group received 1 individual counseling session on lifestyle modification plus print versions of the intervention material. The primary outcome was within-patient change in systolic BP (SBP) and diastolic BP (DBP) from baseline to 6 months. The secondary outcome was BP control at 6 months., Results: Mean age of the total sample was 57 (10.2) years; 50% were women, and the mean baseline BP was 147.4/89.3mm Hg. Eighty-four percent of SSC and 77% of MINT-TLC patients completed the final 6-month assessments. BP declined significantly (P < 0.001) in both groups at 6 months with a net-adjusted systolic BP reduction of 12.9 mm Hg for the SSC group vs. 9.5mm Hg for the MINT-TLC group (P = 0.18); and diastolic BP reduction of 7.6 and 7.2mm Hg for the SSC and MINT-TLC group, respectively (P = 0.79). The between-group difference in proportion of patients with adequate BP control at 6 months was nonsignificant (P = 0.82)., Conclusion: A significant group difference in BP between the intervention groups was not observed among a sample of hypertensive Blacks. Implementation of the pragmatic single-session intervention and its effects on utilization of healthcare services should be further evaluated., Clinical Trial Registration: Trial Number NCT01070056 at http://clinicaltrials.gov/ct2/show/NCT01070056?term=TLC+clinic&rank=1., (© American Journal of Hypertension, Ltd 2015. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)