Stress Reduction and Hypertension Prevention in African Americans

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stress Reduction and Hypertension Prevention in African Americans

Conditions
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High Blood Pressure

Intervention / Treatment
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* Behavioral: Health Education
* Behavioral: Transcendental Meditation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meditation<br>The Transcendental Meditation program is described as a simple natural technique practiced for 20 minutes twice daily for deep rest and relaxation. Previous studies have shown its feasibility, validity, and reliability in Blacks at risk for CVD. | Behavioral: Transcendental Meditation<br>* TM is described as simple technique practiced 20 minutes twice a day for deep rest and relaxation.<br>* Other names: TM technique;|
| Active Comparator: Health Education<br>Health education program matched to the experimental intervention for time, attention, and other non-specific factors. | Behavioral: Health Education<br>* didactic classroom instruction on improving ones lifestyle through healthier diet, exercise and control of substance use.<br>* Other names: lifestyle modification;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Both systolic and diastolic BP are measured using standard clinical trial technique recommended by the American Heart Association (AHA) | baseline 0 to 36 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anger | Anger is measured using the Spielberger State-Trait scale (24 item, 4 pt likert response scale-'almost never to almost always'). Anger-in, anger-out and anger-total scores were recorded as secondary outcomes because anger has been reported to be associated with the progression of BP | baseline 0 to 36 months after baseline | 
| Hypertensive events | Hypertensive events were defined as SBP ≥140 and/or DBP ≥90 mm Hg on two successive occasions or first prescribed use of antihypertensive medications. | baseline 0 to 36 months after baseline | 
| Heart rate | Heart rate (bpm) was measured manually by the technician/nurse who counted the subjects pulse in the right radial artery | baseline 0 to 36 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure, Stress reduction, Meditation, lifestyle modification