Clinical trial NCT02019953: Effects of Health Promoting Programs on Cardiovascular Disease Risk
Official title: Effects of Health-Promoting Programs on Cardiovascular Disease Risk: JHS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary outcomes for this feasibility study will focus on composite measures for recruitment, retention, and the reasons for refusal or dropout.
timeFrame: Bi-annual for up to 52 weeks after enrollment
Secondary outcomes:
measure: Changes in participants' hypertension profiles.
timeFrame: 48 weeks
measure: Changes in participants' inflammation markers
timeFrame: 48 weeks
measure: Changes in participants' lipids profiles.
timeFrame: 48 weeks
measure: Changes in participants' HbA1c levels.
timeFrame: 48 weeks
measure: Changes in participants' reported health-related quality of life.
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Gailen D Marshall, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: