Design, Setting, and Participants
Parallel-group, phase 2, sequentially preregistered randomized clinical trials were conducted from June 1, 2017, to November 30, 2020. Follow-up was 6 months. Participants with elevated unattended office BP (≥120/80 mm Hg) were recruited from the population near Providence, Rhode Island. Of 348 participants assessed for eligibility, 67 did not meet inclusion criteria, 17 declined, and 63 did not enroll prior to study end date. In total, 201 participants were randomly assigned, 101 to the MB-BP program and 100 to the enhanced usual care control group, with 24 (11.9%) unavailable for follow-up. Outcome assessors and the data analyst were blinded to group allocation. Analyses were performed using intention-to-treat principles from June 1, 2022, to August 30, 2023.