High Blood Pressure
Conditions
Keywords
Blood pressure, Stress reduction, Meditation, lifestyle modification
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.
Interventions
BEHAVIORALHealth Education
didactic classroom instruction on improving ones lifestyle through healthier diet, exercise and control of substance use.
BEHAVIORALTranscendental Meditation
TM is described as simple technique practiced 20 minutes twice a day for deep rest and relaxation.
Sponsors
Medical College of Wisconsin
Maharishi International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
This is a single-blind randomized controlled trial with all data collection personnel and investigators blinded to subjects' treatment status. The study coordinator does not collect data but receives subjects assigned treatment and then to informs them of their treatment group
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
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | baseline 0 to 36 months after baseline | Both systolic and diastolic BP are measured using standard clinical trial technique recommended by the American Heart Association (AHA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anger | baseline 0 to 36 months after baseline | 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 |
| Hypertensive events | baseline 0 to 36 months after baseline | Hypertensive events were defined as SBP ≥140 and/or DBP ≥90 mm Hg on two successive occasions or first prescribed use of antihypertensive medications. |
| Heart rate | baseline 0 to 36 months after baseline | Heart rate (bpm) was measured manually by the technician/nurse who counted the subjects pulse in the right radial artery |
Outcome results
None listed