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OpenTrials
Completed

NCT Number: NCT04821505

Stress Reduction and Hypertension Prevention in African Americans

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.

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Key information

Conditions

High Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Education

Behavioral

didactic classroom instruction on improving ones lifestyle through healthier diet, exercise and control of substance use.

Other names: lifestyle modification

Transcendental Meditation

Behavioral

TM is described as simple technique practiced 20 minutes twice a day for deep rest and relaxation.

Other names: TM technique

Primary outcomes

  1. Blood pressure

    Time frame: 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 outcomes

  1. Anger

    Time frame: 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

  2. Hypertensive events

    Time frame: 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.

  3. Heart rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Maharishi International University

Other

Collaborators

  • Medical College of Wisconsin

Registry information

Acronym: Milw2

Important dates

Study start
1998
Primary completion
2004
Study completion
2005
First posted
Mar 29, 2021
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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