Clinical trial NCT04821505: Stress Reduction and Hypertension Prevention in African Americans
Official title: Stress Reduction and Hypertension Prevention in African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: High Blood Pressure
Keywords: Blood pressure
Stress reduction
Meditation
lifestyle modification
Lead sponsor: Maharishi International University
Sponsor class: OTHER
Collaborators: name: Medical College of Wisconsin
First posted: 2021-03-29
Enrollment: 304
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Meditation (Transcendental Meditation, TM) was employed as a lifestyle modification strategy compared to a health education control with exercise and dietary recommendations but with no stress management component
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* self-identified Black women and men
* no current antihypertensive medications
* high normal BP (130-139 mm Hg and/or DBP 85-89 mm Hg) OR
* normal BP (SBP 120-129 mm Hg and/DBP 80-84 mm Hg)

Exclusion Criteria:

* use of antihypertensive medications within the previous 2 months
* history of CVD, ie, myocardial infarction, angina, peripheral artery disease, heart failure, stroke, or renal failure, diabetes, major psychiatric or substance use disorder other life-threatening illness
* lack of signed a consent form

Primary outcomes:
measure: Blood pressure
timeFrame: baseline 0 to 36 months after baseline
Secondary outcomes:
measure: Anger
timeFrame: baseline 0 to 36 months after baseline
measure: Hypertensive events
timeFrame: baseline 0 to 36 months after baseline
measure: Heart rate
timeFrame: baseline 0 to 36 months after baseline
Other outcomes:
Locations:
Study officials:
affiliation: Maharishi International University
name: Robert H Schneider, M.D.
role: PRINCIPAL_INVESTIGATOR
References: