Effects of Health Promoting Programs on Cardiovascular Disease Risk

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Other: Walking; Other: Yoga; Other: Healthy Lifestyles Education

• Registration Number: NCT02019953
• Lead Sponsor: University of Mississippi Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-04-30
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-24
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Walking 3 times per week	Walking	Walking 3x per week for 24 weeks; 48 week follow-up
Yoga 3 times per week	Yoga	Yoga participation 3 x per week for 24 weeks; 48 week follow-up.
Yoga 2 times per week	Yoga	Yoga participation 2 x per week for 24 weeks; 48 week follow-up
Yoga 1 time per week	Yoga	Yoga participation 1 x per week for 24 weeks; 48 week follow-up
Healthy Lifestyles Education	Healthy Lifestyles Education	Healthy Lifestyles Education Participation 1 x per week for 24 weeks; 48 week follow-up

Primary Outcome Measures

Name	Time	Method
Primary outcomes for this feasibility study will focus on composite measures for recruitment, retention, and the reasons for refusal or dropout.	Bi-annual for up to 52 weeks after enrollment	Primary outcomes for this feasibility study will focus on measures for recruitment, retention, and the reasons for refusal or dropout, and consist of (1) agreement to participate in the study (recruitment); (2) reasons for participating/not-participating; (3) dropout, defined as a monotone missingness pattern of stopping participation before completion of the study; (4) reasons for discontinuation/dropout; (5) attendance, defined as the potentially non-monotone pattern of coming to the scheduled study session; and (6) adherence, defined as attending and completing the scheduled sessions and clinical visits.

Secondary Outcome Measures

Name	Time	Method
Changes in participants' hypertension profiles.	48 weeks	Defined using measures of their systolic and diastolic blood pressure
Changes in participants' inflammation markers	48 weeks	Defined using measures of participants' hsCRP, fibrinogen, homocysteine, and interleukin-6 levels.
Changes in participants' reported health-related quality of life.	48 weeks	Quality of life measured as measured by perceived stress, health behaviors, sleep patterns, and impact of pain on everyday life.
Changes in participants' lipids profiles.	48 weeks	Defined as using measures of participants' fasting total cholesterol, LDL, HDL, and triglycerides.
Changes in participants' HbA1c levels.	48 weeks	Changes in participants' HbA1c levels.

Trial Locations

Locations (1)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States