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| Name | Class |
|---|---|
| Morehouse School of Medicine | OTHER |
| Howard University | OTHER |
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This randomized controlled trial compared the efficacy of stress reduction with meditation to a health education (HE) group in 201 older African American women over a one-year study period. They were randomly allocated to either of two behavioral treatment groups-the Transcendental Meditation (TM) program or a health education (HE) program. Participants were recruited, tested, and instructed at two clinical sites: Howard University Hospital, Washington, DC and Morehouse (School of Medicine) Healthcare, Atlanta, GA. Main outcome measures were carotid intima-media thickness, insulin resistance, and behavioral factors.
This was a randomized controlled trial that compared the effects of stress reduction using the Transcendental Meditation technique (TM) to a health education (HE) group in 201 African American women >55 years with CVD or at high CVD risk over a one-year intervention and follow-up period.
All participants were randomly allocated to either of two behavioral treatment groups-1) the Transcendental Meditation (TM) program or 2) a health education (HE) program of healthy diet, exercise and substance use control. Women participants were recruited, tested, and instructed at two sites:139 were recruited and randomized in Washington, DC and 61 in Atlanta, GA. Outcome measures were carotid intima-media thickness (IMT), insulin resistance, serum lipids, blood pressure and lifestyle (diet, exercise, substance use).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcendental Meditation | Experimental | The TM technique is practiced for 20 minutes twice a day. Participants were instructed by a certified teacher in 7-step course to learn how to meditate according to previously standardized and validated procedures. |
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| Health Education | Active Comparator | The health education group was matched for instructor time and attention to the TM group. The classroom-based health education group received AHA-based guidelines for healthy diet, exercise and control of substance use. No stress management techniques are taught in this group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Education | Behavioral | This was a didactic classroom-based control which educates the patient on adapting a healthier lifestyle through proper diet, exercise, and moderating substance usage according to current AHA guidelines. This intervention does not include a stress management component. |
| Measure | Description | Time Frame |
|---|---|---|
| Carotid intima-media thickness (CIMT) | B mode ultrasound measurement of carotid artery wall thickness | 0 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | Hb1c as surrogate endpoint for diabetes | Before and after 12 months of intervention and follow up |
| Insulin resistance | HOMA index utilizing glucose and insulin levels at timed intervals |
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Inclusion Criteria:
Either/or:
OR a risk factor assessment score of at least two points based on the Framingham study/ATP III report. Risk factors included diabetes, high systolic or diastolic BP, high cholesterol, high LDL-low HDL or smoking.
Exclusion Criteria:
Recent (last 3 months):
self identified women
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| Name | Affiliation | Role |
|---|---|---|
| Linda Heaton | Institute for Natural Medicine and Prevention, Maharishi International University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Howard University Heart Center | Washington D.C. | District of Columbia | United States | |||
| Morehouse School of Medicine - Morehouse Medical Associates |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D024821 | Metabolic Syndrome |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| 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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This was a phase 2 randomized controlled trial of two behavioral interventions-Meditation and Health Education.
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Investigators, data collectors and usual medical providers were blinded to participant treatment status. Participants in both intervention groups were given similar expectations of positive outcomes.
|
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| Transcendental Meditation | Behavioral | TM was taught in a standardized and validated format as a simple, natural mental technique practiced for 20 minutes twice a day (morning and evening) to give rest and relaxation to mind and body. TM was taught by a certified instructor and a 7-step process taking place over 4 consecutive days after which the meditator can practice at home twice a day. |
|
|
| 0 and 12 months |
| Lipids | fasting levels of serum LDL, HDL, TC, TG | 0 and 12 months |
| Blood pressure | measured three times with a mercury sphygmomanometer 5 minutes apart and last two reading averaged | 0, 4 and 12 months |
| Physical Activity | Exercise --using the Folsom Physical Activity Questionaire | 0, 4 and 12 months |
| Atlanta |
| Georgia |
| United States |
| D007333 |
| Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D012064 |
| Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |