Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Life's Essential 8 Composite Score change |
Changes from baseline in Life's Essential 8 score. Life's Essential 8 composite score is determined as a composite of all components by calculating an unweighted average score on a scale of 0 to 100 points. An overall cardiovascular health score (Life's Essential 8 score) will be considered high (80 to 100 points), moderate (50 to 79 points) or low for (0 to 49 points). |
Baseline, 6-months and 12-months post-randomization |
|
| Primary |
Blood Pressure Score Change (Life's Essential 8 Component) |
Average of 3 sitting measurements of systolic and diastolic pressures (mmHg). |
Baseline, 6-months and 12-months post-randomization |
|
| Primary |
Fasting Glucose/Hemoglobin A1c Score Change (Life's Essential 8 Component) |
Fingerstick blood collection (fasting glucose-mg/dL; Hemoglobin A1c-%). |
Baseline, 6-months and 12-months post-randomization |
|
| Primary |
Fasting Blood Lipids Score Change (non-HDL cholesterol) (Life's Essential 8 Component) |
Fingerstick blood collection (mg/dL). |
Baseline, 6-months and 12-months post-randomization |
|
| Primary |
Body Mass Index (BMI) Score Change (Life's Essential 8 Component) |
Calculated by weight (kg) and height (m). |
Baseline, 6-months and 12-months post-randomization |
|
| Primary |
Tobacco/Nicotine Exposure Score Change (Life's Essential 8 Component) |
Changes from baseline in smoking status using the National Health and Nutrition Examination Survey-Smoking-Cigarette Use Questionnaire (NHANES-SMQ), evaluating current and past tobacco use habits. |
Baseline, 6-months and 12-months post-randomization |
|
| Primary |
Dietary Quality Score Change (Life's Essential 8 Component) |
Changes from baseline in healthy diet using the Mediterranean Eating Patterns for Americans (MEPA), a 16-item questionnaire evaluating accordance with a Mediterranean-like diet pattern. |
Baseline, 6-months and 12-months post-randomization |
|
| Primary |
Physical Activity Score Change (Life's Essential 8 Component) |
Change from baseline in the total minutes per week that a participant engaged in moderate and vigorous intensity physical activity at immediate post-intervention. Physical activity will be measured by the International Physical Activity Questionnaire (IPAQ). |
Baseline, 6-months and 12-months post-randomization |
|
| Primary |
Sleep Health Score Change (Life's Essential 8 Component) |
Changes from baseline in sleep quality (number of hours of sleep nightly) using the Pittsburg Sleep Quality Index (PSQI). |
Baseline, 6-months and 12-months post-randomization |
|
| Secondary |
Digital Health Readiness |
Assessed using a validated, 20-item instrument that captures 5 domains: digital skills, digital usage, digital literacy, digital health literacy, and digital learnability adapted for all digital health technologies such as smartphone apps. |
Baseline, 3 months post-randomization |
|
| Secondary |
Social Support - Diet |
Diet social support measured using the Social Support for Eating Habits Survey scale. This scale assesses the level of encouragement or discouragement from family and friends that participants received for adopting healthier eating habits. 5 questions were asked to assess the degree of encouragement and discouragement, separately, on a 5-point scale [from 1 (none) to 5 (very often)]. Each sub-item was summed to obtain a score ranging from 5 (lowest) to 25 (highest discouragement/encouragement). The change in level of diet social support was calculated from baseline to 6 months post-intervention. Higher scores indicate more change in social support for healthy eating. |
Baseline, 3 months, 6 months, and 12 months post-randomization |
|
| Secondary |
Self Regulation - Diet |
Diet self-regulation measured by the Health Beliefs Survey to assess strategies used in the past 3 months to eat healthier foods. Items are measured on a five-point scale from 1 (never) to 5 (always). A mean of all items is obtained and a difference between the scores is calculated. Higher change in scores indicate more change in use of self-regulation strategies to promote healthy eating. |
Baseline, 3 months, 6 months, and 12 months post-randomization |
|
| Secondary |
Perceived Barriers - Diet |
Changes from baseline to 12 months post-intervention in diet perceived barriers measured by Barriers to Diet and Exercise questionnaire. The 39-item instrument is measured on a five-point scale from 1 (not at all true for me) to 5 (very true for me); participants indicate the extent to which each factor has made it difficult for them to follow appropriate eating and exercise habits in the past 6 months. |
Baseline, 3 months, 6 months, and 12 months post-randomization |
|
| Secondary |
Social Support - Physical Activity |
Physical activity social support measured using the Social Support for Exercise Survey scale. This scale assesses the level of encouragement or discouragement from family and friends that participants received for adopting healthier physical activity habits. 5 questions were asked to assess the degree of encouragement and discouragement, separately, on a 5-point scale [from 1 (none) to 5 (very often)]. Each sub-item was summed to obtain a score ranging from 5 (lowest) to 25 (highest discouragement/encouragement). The change in level of physical activity social support was calculated from baseline to 6 months post-intervention. Higher scores indicate more change in social support for physical activity. Family Participation was calculated as a sum of 10 items: 10 = low to 50 = high; Family Rewards/Punishment as a sum of 3 items: 3 = low to 15 = high; and Friend Participation sum of 10 items: 10 = low to 50 = high. |
Baseline, 3 months, 6 months, and 12 months post-randomization |
|
| Secondary |
Self Regulation - Physical Activity |
Physical activity self-regulation measured by the Health Beliefs Survey to assess strategies used in the past 3 months to increase their step count or physical activity levels. Items are measured on a 10-item five-point scale from 1 (never) to 5 (always). The mean of the ten items is obtained. The difference in the mean scores from baseline to 6 months post-intervention is calculated. Larger change in scores indicate more change in self-regulation. |
Baseline, 3 months, 6 months, and 12 months post-randomization |
|
| Secondary |
Perceived Barriers - Physical Activity |
Changes from baseline to 12 months post-intervention in diet perceived barriers measured by Barriers to Diet and Exercise questionnaire. The 39-item instrument is measured on a five-point scale from 1 (not at all true for me) to 5 (very true for me); participants indicate the extent to which each factor has made it difficult for them to follow appropriate eating and exercise habits in the past 6 months. |
Baseline, 3 months, 6 months, and 12 months post-randomization |
|
| Secondary |
Artificial Intelligence (AI)-Electrocardiogram (ECG) |
Standard 12-lead ECG to be analyzed by a Mayo Clinic AI-enhanced ECG model for detection of left ventricular dysfunction and correlation of actual age and AI-ECG predicted age. |
Baseline, 6 months and 12 months post-randomization |
|
| Secondary |
Cardio-ankle vascular index (CAVI) |
The cardio-ankle vascular index (CAVI) is a measure of arterial stiffness that reflects the stiffness from the ascending aorta to the ankle arteries. Normal CAVI values are less than 8 and values greater than or equal to 9 are classified as abnormal. |
Baseline, 6 months and 12 months post-randomization |
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