High Blood PressurePhase 2Milw2NCT04821505
Stress Reduction and Hypertension Prevention in African Americans
A Phase 2 study testing Health Education and Transcendental Meditation in people with High Blood Pressure, run by Maharishi International University.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- Health Education and Transcendental Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- No sites listed yet
- Study dates
- 1 May 1998to 30 Apr 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- High Blood Pressure
- Being tested
- Health Education, Transcendental Meditation
- Keywords
- Blood pressure, Stress reduction, Meditation, lifestyle modification
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health EducationBehavioural
Also called lifestyle modification
didactic classroom instruction on improving ones lifestyle through healthier diet, exercise and control of substance use.
Transcendental MeditationBehavioural
Also called TM technique
TM is described as simple technique practiced 20 minutes twice a day for deep rest and relaxation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Transcendental Meditation |
| Health Education | Active comparator | Health education program matched to the experimental intervention for time, attention, and other non-specific factors. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Both systolic and diastolic BP are measured using standard clinical trial technique recommended by the American Heart Association (AHA)
Measured: baseline 0 to 36 months after baseline
Secondary outcomes (3)
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
Measured: 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.
Measured: 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
Measured: baseline 0 to 36 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 May 1998
- Primary completion1 Oct 2004
- Study completion30 Apr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi International University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical College of Wisconsin
- Responsible party
- Principal investigator, Robert Schneider, MD, Maharishi International University
- Investigators
- Robert H Schneider, M.D., Principal investigator, Maharishi International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821505
- Sponsor's protocol ID
- HL60703-02
- Acronym
- Milw2
- Status last verified
- May 2021
- First submitted
- 17 Mar 2021
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Reduction and Hypertension Prevention in African Americans
- ClinicalTrials.gov ID
- NCT04821505
- Acronym / sponsor ID
- Milw2 / HL60703-02
- Conditions
- High Blood Pressure
- Keywords
- Blood pressure, Stress reduction, Meditation, lifestyle modification
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Maharishi International UniversityUniversity, hospital or other
- Collaborators
- Medical College of Wisconsin
- Study start
- 1 May 1998 (actual)
- Primary completion
- 1 Oct 2004 (actual)
- Study completion
- 30 Apr 2005 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Meditation | Experimental | Behavioral: Transcendental MeditationThe 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. |
| Health Education | Active comparator | Behavioral: Health EducationHealth education program matched to the experimental intervention for time, attention, and other non-specific factors. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health EducationAlso: lifestyle modificationdidactic classroom instruction on improving ones lifestyle through healthier diet, exercise and control of substance use. | Behavioural | Health Education |
| Transcendental MeditationAlso: TM techniqueTM is described as simple technique practiced 20 minutes twice a day for deep rest and relaxation. | Behavioural | Meditation |
Primary outcome
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)
3 secondary outcomes
Anger
Time frame: baseline 0 to 36 months after baseline
Hypertensive events
Time frame: baseline 0 to 36 months after baseline
Heart rate
Time frame: baseline 0 to 36 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert H Schneider, M.D. principal investigator
Maharishi International University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Health Education and Transcendental Meditation in people with High Blood Pressure, run by Maharishi International University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: baseline 0 to 36 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.