Study Design, Setting, and Participants
RECRUITMENT, BROWN
The MB-BP study was a parallel-group phase 2 RCT comparing group-based mindfulness meditation training adapted to improving health behaviors that lower BP vs an enhanced usual care control. Participants were recruited and enrolled from June 1, 2017, to November 30, 2020, through advertising in local communities and referrals from clinicians. The study protocol was approved by the Brown University institutional review board. The trial was registered with ClinicalTrials.gov at the onset of participant recruitment (applied in July 2017, approved in August 2017) and prior to outcome assessment in participants. Participants provided written informed consent. Data were not examined prior to registration. This study followed the Consolidated Standards of Reporting Trials (Inclusion criteria were English-speaking adults (≥18 years of age) with elevated unattended office BP (ie, systolic blood pressure [SBP] ≥120 mm Hg or diastolic BP [DBP] ≥80 mm Hg).This study combined 2 preregistered RCTs with identical methods that were part of a larger study, described elsewhere.