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Clinical Trials Assignment

Study Name and Link: Stress Reduction and Hypertension Prevention in African Americans (Milw2)

https://clinicaltrials.gov/ct2/show/NCT04821505?cond=High+Blood+Pressure&draw=2&rank=5

Aim of the study: The study aims to evaluate the effect of stress reduction through the Transcendental Meditation (TM) technique in Black adults with high normal blood pressure and normal blood pressure on reducing health disparities associated with hypertension, cardiovascular disease (CVD), and psychosocial stress.

Study design: The study is a randomized controlled trial (clinical trial) with two arms: TM and health education (HE). The research plan and protocol are not available on the clinical trials website.

Lead Investigator and team: The study’s lead investigator is Robert Schneider, MD, from Maharishi International University. The team includes other researchers and medical professionals, but their names are not listed.

Sponsor/funding: Maharishi International University is sponsoring the study, and the Medical College of Wisconsin is collaborating.

Recruitment status and government evaluation: The study’s recruitment status says completed, and it was first posted on March 29, 2021. The study has not been evaluated by the US federal government.

Procedures of the study: The study enrolled 304 Black adults with high normal blood pressure and normal blood pressure who were randomized to either TM or HE. Blood pressure was recorded at various intervals over 36 months, and linear mixed model analysis was used to compare the change in blood pressure between the TM and HE groups in the high-normal BP and normal-BP groups. Survival analysis was conducted to assess hypertensive events. The study aimed to evaluate the effect of TM on reducing blood pressure and health problems associated with hypertension, CVD, and psychosocial stress.