Counseling older Americans to control hypertension (COACH)

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Abstract Despite the proven efficacy and compelling evidence of the beneficial effects of therapeutic lifestyle changes (TLC) on BP reduction in large clinical trials conducted in academic research settings, its effectiveness in community-based settings remains unclear. This is particularly true among elderly patients who tend to have an abysmally low rate of BP control, especially minority elders, who share a greater burden of hypertension (HTN)-related outcomes including heart failure, stroke, and end-stage kidney disease compared to whites. This RCT offers a unique opportunity to address this gap in the literature. We will evaluate the effect of a senior center-based comprehensive therapeutic lifestyle intervention (MINT-TLC) vs. a Control Condition (CC), on BP reduction. We hypothesize that minority elders randomized to MINT-TLC will exhibit at 12 months a greater BP reduction; increased intake of fruits and vegetables; higher levels of physical activity; higher percent change in weight; reduced 24-hour urinary sodium excretion; and a higher proportion of seniors with adequate BP control. Two hundred Latino and African-American seniors (age > 60 years) with poorly controlled HTN (BP>140/90 mm Hg) will be enrolled from community-based senior centers affiliated with the New York City Department for The Aging. Seniors in the CC condition will receive a single brief advice session on TLC and print versions of NHLBI publications "Your Guide to Lowering Blood Pressure"; and "Facts about the DASH Eating Plan". Seniors in the MINTTLC group will attend weekly group classes for 10 weeks (intensive phase); followed by monthly individual motivational interviewing (MINT) sessions for three months (extended phase); and then bi-monthly individual booster MINT sessions for six months (maintenance phase). MINT-TLC is designed to help participants make appropriate TLC and develop skills to maintain these changes long-term. MINT-TLC will be delivered by trained research personnel. The primary outcome is within-patient change in BP from baseline to 12 months The secondary outcomes are levels of targeted therapeutic lifestyle behaviors; and proportion of seniors with adequate BP control at 12 months (BP<140/90 mm Hg). All outcomes will be assessed in-person at baseline and 12 months by using well-validated procedures and measures. BP will be assessed with an automated digital BP monitor. Therapeutic lifestyle behaviors will be assessed with NCI's brief fruit/vegetable and fat dietary assessment questionnaires; and the 7-day physical activity recall. The longterm goal is to refine MINT-TLC and integrate it into routine senior center hypertension monitoring programs as a result of the data obtained; thus maximizing the likelihood of its translation into standard practice.