Effects of Health Promoting Programs on Cardiovascular Disease Risk



Status:Completed
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:5/12/2016
Start Date:July 2012
End Date:September 2014

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Effects of Health-Promoting Programs on Cardiovascular Disease Risk: JHS

The overall approach to the study is to assess the feasibility of recruiting African
Americans to participate in several health-promoting programs and to compare health outcomes
among the three interventions.

The project is designed to achieve five specific aims: (1) To determine the feasibility of
attracting African Americans into Health Promotion Research studies;(2) To determine whether
clinically recorded information can be used as a guide for recruitment inclusion in Health
Promotion Studies from an active epidemiological research cohort;(3) To measure the ability
to retain African Americans recruited into Health Promotion Studies from an active research
cohort;(4) To measure the adherence to various protocols within a Health promotion Study;
and(5) To provide informed estimates of effect sizes for designing future Health Promotion
Research.

A total of 375 study participants from the Jackson Heart Study (JHS) cohort, all of whom are
African American, will be randomly assigned to one of five, equally-sized study arms: (1)
practicing yoga three times per week; (2) practicing yoga two times per week; (3) practicing
yoga one time per week; (4) walking briskly three times per week; and (5) attending a weekly
healthy lifestyles class.

All study arms will include a 24-week intervention. In addition, participants will have a
total of four clinical visits with members of the study team baseline, 12 weeks, 24 weeks,
and 48 weeks) in which the following measures will be recorded:

1. Systolic and diastolic blood pressure and heart rates

2. Highly sensitive C-reactive protein (hsCRP) - serum, fibrinogen - plasma (sodium
citrate), homocysteine (plasma), and interleukin-6 levels (IL-6) (serum).

3. Fasting total cholesterol, low density (LDL), direct high density lipoprotein (HDL),
and triglyceride levels - all serum

4. HbA1c level

5. BMI, waist circumference

6. Medication and supplement use and dosages

7. Results of a study survey designed to measure participants' changes in their reported
health-related quality of life, perceived stress, health behaviors, sleep patterns, and
impact of pain on everyday life

In addition, we will also record systolic and diastolic blood pressure and heart rates
before and after each intervention session for all five study arms.

Inclusion Criteria:

- This study includes only one inclusion criterion: to participate in this study, one
needs to be a member of the Jackson Heart Study cohort.

Exclusion Criteria:

- 1. Newly diagnosed (within the last six weeks) with a myocardial infarction,
cerebrovascular disease, atrial fibrillation, cardiomyopathy, valvular heart disease,
fatal cardiac arrhythmia, severe systolic and diastolic heart failure, uncontrolled
COPD, uncontrolled moderate to severe hypertension, or a recent recipient of a
pacemaker, and/or

2. Change in blood pressure medicine or lipid-lowering medication up to 30 days prior
to or plans for a change in the 30 days after enrollment in the study, and/or

3. Already practicing yoga at least once per week or walking briskly for one hour at
least three times per week, and/or

4. Inability to attend protocol sessions, and/or

5. Diagnosis of an underlying medical illness that might be considered by the
principal investigator to potentially impair one's safety or ability to complete the
study protocol (example could possibly include uncontrolled asthma), and/or

6. Current use of a prescription regimen that might be considered by the principal
investigator to potentially impair one's safety or ability to complete the study
protocol (examples could possibly include use of sedatives or other drugs that could
affect a participant's ability to participate in any of the study arms).

7. Pregnant or planning to become pregnant in the next six (6) months.
We found this trial at
1
site
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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mi
from
Jackson, MS
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