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| Name | Class |
|---|---|
| Medical College of Wisconsin | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meditation | Experimental | 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. |
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| Health Education | Active Comparator | Health education program matched to the experimental intervention for time, attention, and other non-specific factors. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Education | Behavioral | didactic classroom instruction on improving ones lifestyle through healthier diet, exercise and control of substance use. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert H Schneider, M.D. | Maharishi International University | Principal Investigator |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019122 | Meditation |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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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
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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
|
| Transcendental Meditation | Behavioral | TM is described as simple technique practiced 20 minutes twice a day for deep rest and relaxation. |
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| 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 |
| D012064 |
| Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |