Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in Weekly Moderate-to-Vigorous Physical Activity |
Participants will wear a physical activity tracker around their waist for 7 days to assess the number of minutes of MVPA. |
Baseline, Month 6 |
|
Primary |
Change in Number of Participants Adhering to PA Guidelines |
Adherence to PA Guidelines will be defined as achieving =150 min of MVPA per week. Percent change in adherence is calculated as: [(Post-intervention MVPA - Baseline MVPA)/Recommended MVPA×100]. |
Baseline, Month 6 |
|
Primary |
Change in Step Count |
Daily step count will be measured with a physical activity tracker worn on the wrist for at least 10 hours per day while awake. |
Baseline, Month 6 |
|
Primary |
Change in 2013 Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator |
The algorithm provides sex and race-specific estimates for the first CVD event for black and white men and women. The scores range from 0-100% with higher scores representing poor cardiovascular health status. The between group difference in risk score change is computed as the end of study score minus the baseline score. |
Baseline, Month 6 |
|
Secondary |
Change in Waist Circumference |
Waist circumference is measured in centimeters (cm). |
Baseline, Month 6 |
|
Secondary |
Change in Weight |
Weight is measured in kilograms (kg). |
Baseline, Month 6 |
|
Secondary |
Change in Systolic Blood Pressure |
Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Normal systolic blood pressure as lower than 120 millimeters of mercury (mmHg). |
Baseline, Month 6 |
|
Secondary |
Change in Diastolic Blood Pressure |
Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Normal diastolic blood pressure as lower than 80 mmHg. |
Baseline, Month 6 |
|
Secondary |
Change in Life's Essential 8™ Score |
Life's Essential 8 is a way to assess cardiovascular health developed by the American Heart Association. Life's Essential 8 has 8 components: diet, physical activity, exposure to nicotine, sleep, body mass index (BMI), blood lipids, blood glucose, and blood pressure. Each component is scored with an algorithm and scores range from 0 to 100. A composite score of overall cardiovascular health can be generated and it also ranges from 0 to 100. A score of 0 indicates a low health score, a score of 50 indicates moderate health, and a score of 100 is the highest health for each of the 8 components as well as the overall score. |
Baseline, Month 6 |
|
Secondary |
Change in Hemoglobin A1c |
The hemoglobin A1c test result reflects average blood sugar level over the past three months. Specifically, the A1c test measures what percentage of hemoglobin is coated with sugar (glycated). Values below 5.7% are normal, values between 5.7% and 6.4% indicate prediabetes, and values of 6.5% and higher indicate diabetes. |
Baseline, Month 6 |
|
Secondary |
Change in Adiponectin |
Adiponectin is a hormone released by adipose tissue, and other body tissues, that assists with insulin sensitivity and reducing inflammation. Normal ranges vary depending on sex and BMI and in general lower levels are associated with health conditions of obesity, Type 2 diabetes, and atherosclerosis. In people with a BMI of less than 25, the normal range for males and females is 5 to 37 micrograms per milliliter (µg/mL). In those with a BMI of 25 to 30 the normal range for males is 5 to 28 µg/mL and the normal range for females is 4 to 20 µg/mL. In people with a BMI over 30 the normal range for males is 2 to 20 µg/mL and the normal range for females is 4 to 22 µg/mL. |
Baseline, Month 6 |
|
Secondary |
Change in Total Cholesterol |
Cholesterol is waxy substance which is produced by the liver or comes from food that is consumed. Cholesterol concentrations are commonly used as a marker for cardiovascular disease risk. Healthy levels of total cholesterol are 125 to 200 milligrams (mg) per deciliter (dL). |
Baseline, Month 6 |
|
Secondary |
Change in Low-density Lipoprotein (LDL) Cholesterol |
Healthy levels of LDL cholesterol are below 100mg/dL. |
Baseline, Month 6 |
|
Secondary |
Change in High-density Lipoprotein (HDL) Cholesterol |
HDL cholesterol is the "good" cholesterol because it is a type of fat that removes cholesterol from blood, thereby preventing build up. Healthy levels for HDL cholesterol are 40mg/dL or higher in adult males and 50 mg/dL or higher in adult females. |
Baseline, Month 6 |
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