NCT04821505

Stress Reduction and Hypertension Prevention in African Americans

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Maharishi International University · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

Summary

There are major health disparities in Blacks associated with high blood pressure (BP) and psychosocial stress. We evaluated the effects of lifestyle modification with meditation in Black adults with high normal and normal blood pressure. Participants (n=304) were randomized to either the Transcendental Meditation technique or Health Education control in addition to usual care for up to 36 months for BP and secondary outcomes.

Detailed description

Background: Blacks suffer from disparities in hypertension, cardiovascular disease (CVD) and currently, coronavirus-19. These conditions are associated with social determinants of health and psychosocial stress. While previous trials demonstrated stress reduction lowering blood pressure in grade I range in Blacks, there is a paucity of clinical trial data in Blacks with high normal and normal BP. Objective: This randomized controlled trial was conducted to evaluate the effect of stress reduction with the Transcendental Meditation (TM) technique in Black adults with high normal BP and normal BP using International Society of Hypertension (ISH) definitions. Methods: A total of 304 Black adults with high normal (130-139/85-89 mm Hg) and normal BP (120-129/80-84 mm Hg) were randomized to either TM or health education (HE) arms. BP was recorded at 3, 6, 9, 12, 24, 30, and 36 months after baseline. Linear mixed model analysis was conducted to compare the BP change between TM and HE participants in the high-normal BP and normal-BP groups. Survival analysis for hypertensive events was conducted.

Conditions

• High Blood Pressure

Interventions

Type	Name	Description
BEHAVIORAL	Health Education	didactic classroom instruction on improving ones lifestyle through healthier diet, exercise and control of substance use.
BEHAVIORAL	Transcendental Meditation	TM is described as simple technique practiced 20 minutes twice a day for deep rest and relaxation.

Timeline

• Start date: 1998-05-01
• Primary completion: 2004-10-01
• Completion: 2005-04-30
• First posted: 2021-03-29
• Last updated: 2021-05-07