Atherosclerotic Cardiovascular Disease, Metabolic Syndrome
Conditions
Keywords
Meditation, Transcendental Meditation, Health Education, Prevention, Health Disparities, Women's Health
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALHealth Education
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.
BEHAVIORALTranscendental Meditation
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.
Sponsors
Morehouse School of Medicine
Howard University
Robert Schneider, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
This was a phase 2 randomized controlled trial of two behavioral interventions-Meditation and Health Education.
Eligibility
Sex/Gender
FEMALE
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* African American women, * 55 years or older with at least one of the five cardiovascular conditions (below): Either/or: * coronary heart disease or * positive coronary angiography or * previous MI or * coronary revascularization or * percutaneous transluminal coronary angioplasty (PTCA). 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): * myocardial infarction * unstable angina * coronary artery by-pass grafting (CABG) * percutaneous transluminal coronary angioplasty (PTCA) * stroke within the preceding three months * carotid artery endarterectomy * atrial fibrillation * second or third degree AV block * heart failure * clinically significant valvular heart disease * major psychiatric disorders, * current alcohol/dependency disorder * other drug abuse dependency disorder * non-cardiac life-threatening illness * participating in a formal stress management program * plans to move out of the study area or travel extensively * unwillingness to accept randomization into any study group.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carotid intima-media thickness (CIMT) | 0 and 12 months | B mode ultrasound measurement of carotid artery wall thickness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | Before and after 12 months of intervention and follow up | Hb1c as surrogate endpoint for diabetes |
| Insulin resistance | 0 and 12 months | HOMA index utilizing glucose and insulin levels at timed intervals |
| Lipids | 0 and 12 months | fasting levels of serum LDL, HDL, TC, TG |
| Blood pressure | 0, 4 and 12 months | measured three times with a mercury sphygmomanometer 5 minutes apart and last two reading averaged |
| Physical Activity | 0, 4 and 12 months | Exercise --using the Folsom Physical Activity Questionaire |
Countries
United States
Outcome results
None listed