Rationale and design of the Heart-to-Heart study: A church-based intervention to reduce blood pressure in African Americans

Heart-to-Heart (H2H) is a church-based behavioral cluster randomized trial to measure the effectiveness of a lifestyle education program for reducing blood pressure (BP) in African American adults with uncontrolled BP. Design and implementation of this study were informed by our ALIVE pilot study conducted with church pastors and leaders using a community-based participatory research methodology. The current study employs a cross-over design in which all participants receive two 6-month programs in different orders: the intervention arm receives the H2H program first, followed by a financial education program, and the comparator arm receives the programs in the reverse order. Approximately 34 churches will be randomized with the aim of including at least 272 participants across churches. The H2H program consists of 24 weekly dietitian-led diet and lifestyle virtual education sessions, 12 Bible studies taught by the church pastor reinforcing positive dietary behaviors from a biblical perspective, daily self-monitoring of BP, and, as needed, one-on-one support from a community health worker to assist with medication adherence. The Money Smart program consists of 14 financial education sessions and 12 Bible studies teaching the biblical basis of good financial management over a 6-month period. The primary outcome measure is systolic BP at 6 months with a follow-up at 12 months. Secondary outcome measures include medication adherence, Dietary Approaches to Stop Hypertension (DASH) diet adherence, self-efficacy for hypertension self-care, social support for eating a healthy diet, hypertension and nutrition knowledge, beliefs about medicines, barriers to medication use, depression, and financial knowledge and behaviors.