NCT02019953

Effects of Health Promoting Programs on Cardiovascular Disease Risk

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 375 (actual)
• Sponsor: University of Mississippi Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
OTHER	Yoga	The yoga intervention, which is taught based on Hatha yoga, will be offered to study participants in Study Arms 1, 2, and 3, is a combination of asanas (poses), pranayams (breathing exercises), and meditation. Blood pressure and heart rate measurements are taken before and after each session.
OTHER	Walking	The walking intervention, which is Study Arm 4 includes, three guided walking sessions per week for 24 weeks. Each class is an hour in length and will include a minimum of 30 minutes of walking at the equivalent of a minimum of three miles per hour. Each session includes a ten-minute warm-up and ten-minute cool-down period of some stretches and walking at a leisurely pace. Blood pressure and heart rate measurements are taken before and after each session.
OTHER	Healthy Lifestyles Education	Participants randomly assigned to the fifth study arm attend one 60-minute healthy lifestyles class per week for 24 weeks. The Healthy Lifestyles curriculum includes 24 independent lesson modules, which allows participants to begin their intervention at any time during the course schedule. Blood pressure and heart rate measurements are taken before and after each session.

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-12-24
• Last updated: 2017-03-08

Locations

1 site across 1 country: United States