Trial · NCT07912671
Registered outcomes62
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 62
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Life's Essential 8 (LE8) Cardiovascular Health Score | From baseline through 12 months | The primary outcome is the between-group difference in the change in the American Heart Association's Life's Essential 8 (LE8) cardiovascular health score from baseline to 12 months. The LE8 score is calculated automatically by the cloud-based system using data on eight cardiovascular health components: physical activity, sleep health, nicotine exposure, diet, blood pressure, blood glucose, blood lipids, and body mass index. Each component is scored from 0 to 100, and the overall LE8 score is calculated as the unweighted average of the eight component scores, ranging from 0 to 100. Higher scores indicate better cardiovascular health. |
| Secondary | Change in Life's Essential 8 (LE8) Blood Lipids Component Score | From baseline through 12 months | The Life's Essential 8 (LE8) Blood Lipids component score is calculated based on non-high-density lipoprotein cholesterol (non-HDL-C), defined as total cholesterol minus high-density lipoprotein cholesterol (HDL-C), according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the blood lipids domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months. |
| Secondary | Change in Life's Essential 8 (LE8) Blood Glucose Component Score | From baseline through 12 months | The Life's Essential 8 (LE8) Blood Glucose component score is calculated based on blood glucose-related measurements according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the blood glucose domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months. |
| Secondary | Change in Life's Essential 8 (LE8) Blood Pressure Component Score | From baseline through 12 months | The Life's Essential 8 (LE8) Blood Pressure component score is calculated based on measured systolic and diastolic blood pressure according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the blood pressure domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months. |
| Secondary | Change in Life's Essential 8 (LE8) Body Mass Index Component Score | From baseline through 12 months | The Life's Essential 8 (LE8) Body Mass Index component score is calculated based on body mass index (BMI), derived from measured height and weight, according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the body mass index domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months. |
| Secondary | Change in Life's Essential 8 (LE8) Physical Activity Component Score | From baseline through 12 months | The Life's Essential 8 (LE8) Physical Activity component score is calculated based on moderate-to-vigorous physical activity (MVPA), measured using the wearable device according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the physical activity domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months. |
| Secondary | Change in Life's Essential 8 (LE8) Sleep Duration Component Score | From baseline through 12 months | The Life's Essential 8 (LE8) Sleep Duration component score is calculated based on sleep duration measured using the wearable device according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the sleep domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months. |
| Secondary | Change in Life's Essential 8 (LE8) Nicotine Exposure Component Score | From baseline through 12 months | The Life's Essential 8 (LE8) Nicotine Exposure component score is calculated based on nicotine exposure assessed using a standardized questionnaire administered through the mobile application according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the nicotine exposure domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months. |
| Secondary | Change in Life's Essential 8 (LE8) Diet Component Score | From baseline through 12 months | The Life's Essential 8 (LE8) Diet component score is calculated based on dietary information collected using a standardized questionnaire administered through the mobile application according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the dietary domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months. |
| Secondary | LE8 Score ≥80 points | 12 months | Proportion of participants with a Life's Essential 8 (LE8) cardiovascular health score ≥80 points at 12 months. The LE8 score ranges from 0 to 100, with higher scores indicating better cardiovascular health. |
| Secondary | Proportion of Participants With an Increase of ≥5 Points in the Life's Essential 8 (LE8) Cardiovascular Health Score at 12 Months | Baseline to 12 months | Cardiovascular health will be assessed using the American Heart Association's Life's Essential 8 (LE8) cardiovascular health score, which ranges from 0 to 100, with higher scores indicating better cardiovascular health. The change in LE8 score will be calculated as the 12-month score minus the baseline score. An improvement is defined as an increase of at least 5 points. The proportion of participants meeting this criterion will be calculated. |
| Secondary | Proportion of Participants With an Increase of ≥10 Points in the Life's Essential 8 (LE8) Cardiovascular Health Score at 12 Months | Baseline to 12 months | Cardiovascular health will be assessed using the American Heart Association's Life's Essential 8 (LE8) cardiovascular health score, which ranges from 0 to 100, with higher scores indicating better cardiovascular health. The change in LE8 score will be calculated as the 12-month score minus the baseline score. An improvement is defined as an increase of at least 10 points. The proportion of participants meeting this criterion will be calculated. |
| Secondary | Proportion of Participants With an Increase of ≥15 Points in the Life's Essential 8 (LE8) Cardiovascular Health Score at 12 Months | Baseline to 12 months | Cardiovascular health will be assessed using the American Heart Association's Life's Essential 8 (LE8) cardiovascular health score, which ranges from 0 to 100, with higher scores indicating better cardiovascular health. The change in LE8 score will be calculated as the 12-month score minus the baseline score. An improvement is defined as an increase of at least 15 points. The proportion of participants meeting this criterion will be calculated. |
| Secondary | Major Adverse Cardiovascular Events (MACE) | From baseline through 12 months | The incidence of the composite endpoint of MACE, including cardiac death, acute myocardial infarction, hospitalization for heart failure, and coronary revascularization. |
| Secondary | Cardiac death | From baseline through 12 months | The incidence of cardiac death. |
| Secondary | Acute myocardial infarction | From baseline through 12 months | The incidence of acute myocardial infarction. |
| Secondary | Hospitalization for heart failure | From baseline through 12 months | The incidence of hospitalization for heart failure. |
| Secondary | Coronary revascularization | From baseline through 12 months | The incidence of coronary revascularization. |
| Secondary | Incidence of New-onset Diabetes Mellitus | From baseline through 12 months | The incidence of newly diagnosed diabetes mellitus during the 12-month follow-up period among participants without diabetes at baseline. New-onset diabetes will be identified based on clinical diagnosis and/or standard diagnostic criteria, including HbA1c ≥6.5%, fasting plasma glucose ≥7.0 mmol/L, or 2-hour plasma glucose ≥11.1 mmol/L during an oral glucose tolerance test. In the absence of unequivocal hyperglycemia, confirmatory testing is required. The incidence will be compared between the two study groups. |
| Secondary | Incidence of New-onset Hypertension | From baseline through 12 months | The incidence of newly diagnosed hypertension during the 12-month follow-up period among participants without hypertension at baseline. New-onset hypertension will be identified based on a documented clinical diagnosis or repeated office blood pressure measurements showing systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, with confirmation according to applicable clinical guidelines. The incidence will be compared between the two study groups. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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