Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT04821505
Status:
COMPLETED
Last Update Posted:
2021-05-07
First Post:
2021-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stress Reduction and Hypertension Prevention in African Americans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019122', 'term': 'Meditation'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "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"}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 304}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2005-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-04', 'studyFirstSubmitDate': '2021-03-17', 'studyFirstSubmitQcDate': '2021-03-26', 'lastUpdatePostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2004-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'baseline 0 to 36 months after baseline', 'description': 'Both systolic and diastolic BP are measured using standard clinical trial technique recommended by the American Heart Association (AHA)'}], 'secondaryOutcomes': [{'measure': 'Anger', 'timeFrame': 'baseline 0 to 36 months after baseline', 'description': "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"}, {'measure': 'Hypertensive events', 'timeFrame': 'baseline 0 to 36 months after baseline', 'description': 'Hypertensive events were defined as SBP ≥140 and/or DBP ≥90 mm Hg on two successive occasions or first prescribed use of antihypertensive medications.'}, {'measure': 'Heart rate', 'timeFrame': 'baseline 0 to 36 months after baseline', 'description': 'Heart rate (bpm) was measured manually by the technician/nurse who counted the subjects pulse in the right radial artery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood pressure', 'Stress reduction', 'Meditation', 'lifestyle modification'], 'conditions': ['High Blood Pressure']}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants (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.', 'detailedDescription': '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.\n\nObjective: 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.\n\nMethods: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* self-identified Black women and men\n* no current antihypertensive medications\n* high normal BP (130-139 mm Hg and/or DBP 85-89 mm Hg) OR\n* normal BP (SBP 120-129 mm Hg and/DBP 80-84 mm Hg)\n\nExclusion Criteria:\n\n* use of antihypertensive medications within the previous 2 months\n* 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\n* lack of signed a consent form'}, 'identificationModule': {'nctId': 'NCT04821505', 'acronym': 'Milw2', 'briefTitle': 'Stress Reduction and Hypertension Prevention in African Americans', 'organization': {'class': 'OTHER', 'fullName': 'Maharishi International University'}, 'officialTitle': 'Stress Reduction and Hypertension Prevention in African Americans', 'orgStudyIdInfo': {'id': 'HL60703-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meditation', 'description': '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.', 'interventionNames': ['Behavioral: Transcendental Meditation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health Education', 'description': 'Health education program matched to the experimental intervention for time, attention, and other non-specific factors.', 'interventionNames': ['Behavioral: Health Education']}], 'interventions': [{'name': 'Health Education', 'type': 'BEHAVIORAL', 'otherNames': ['lifestyle modification'], 'description': 'didactic classroom instruction on improving ones lifestyle through healthier diet, exercise and control of substance use.', 'armGroupLabels': ['Health Education']}, {'name': 'Transcendental Meditation', 'type': 'BEHAVIORAL', 'otherNames': ['TM technique'], 'description': 'TM is described as simple technique practiced 20 minutes twice a day for deep rest and relaxation.', 'armGroupLabels': ['Meditation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Robert H Schneider, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maharishi International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maharishi International University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical College of Wisconsin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director and Dean', 'investigatorFullName': 'Robert Schneider, MD', 'investigatorAffiliation': 'Maharishi International University'}}}}