The e-DUCASS Advance study is a randomized study evaluating whether a 24-month digital health education program can improve cardiovascular health among people living in Córdoba, Spain, and representing different socioeconomic backgrounds and areas of the city. Approximately 600 participants aged 12 to 79 years will be enrolled. Participants will be assigned by family so that members of the same family remain in the same study group.
All participants will first receive an initial basic health education workshop covering healthy eating, physical activity, sleep, tobacco use, and other health-related behaviors. Families will then be randomly assigned to one of two groups. The control group will receive no additional educational intervention, whereas the digital intervention group will receive weekly educational content through a web-based application or messaging channels. This content will include short videos, infographics, knowledge assessments, motivational activities, and access to support.
Cardiovascular health will be assessed at baseline, 12 months, and 24 months using the American Heart Association's Life's Essential 8 score. This score evaluates diet, physical activity, nicotine exposure, sleep, body mass index, blood lipids, blood glucose, and blood pressure.
The study will compare changes in cardiovascular health between the two groups and examine whether the effect of the program differs according to the socioeconomic characteristics of the participants' areas of residence. Other assessments will include adherence to a Mediterranean lifestyle, health and nutrition literacy, physical activity and sedentary behavior, chronotype, quality of life, anxiety, and depression.
Age 12 to 79 years.
Provision of written informed consent. For participants younger than 18 years, written informed consent from a parent or legal guardian and assent from the participant, when appropriate, are required.
Both healthy individuals and individuals with stable medical conditions are eligible. No specific disease or cardiovascular risk factor is required for participation.
Life expectancy of less than 5 years.
Inability to complete the study intervention or scheduled study procedures, either independently or, when applicable, with support from a parent, legal guardian, or household member.
Serious or unstable medical conditions that could limit participation, follow-up, or survival, including hypertension or diabetes with target-organ damage affecting survival, disabling clinical manifestations of cerebrovascular disease, severe psychiatric illness, advanced chronic kidney disease, chronic liver disease, cancer under active treatment, severe or very severe chronic obstructive pulmonary disease, endocrine disease at risk of decompensation, or clinically significant chronic gastrointestinal disease.
Parallel
Enhanced Digital Health Literacy Program
BehavioralThe intervention is a 24-month enhanced digital health literacy program designed to improve cardiovascular health through sustained education on healthy lifestyles. Participants receive new educational content weekly through a web-based application. Content includes short videos and summary infographics addressing healthy eating, physical activity, sleep health, avoidance of tobacco and nicotine exposure, and other cardiovascular health-related behaviors. The program combines education, evaluation, and motivation. Brief knowledge assessments reinforce learning, while information on content access and views is used to monitor engagement. Motivational activities, participation feedback, and access to support are provided to encourage adherence and sustained behavior change. Content is adapted when appropriate for adolescent participants.
Mean Change From Baseline in Life's Essential 8 Score at 24 Months
Cardiovascular health will be assessed using the American Heart Association's Life's Essential 8 score. The overall score is calculated as the mean of eight component scores: diet, physical activity, nicotine exposure, sleep health, body mass index, blood lipids, blood glucose, and blood pressure. Each component and the overall score range from 0 to 100 points, with higher scores indicating better cardiovascular health.
Mean Change From Baseline in Life's Essential 8 Score at 12 Months
Cardiovascular health will be assessed using the American Heart Association's Life's Essential 8 score. The overall score is calculated as the mean of eight component scores: diet, physical activity, nicotine exposure, sleep health, body mass index, blood lipids, blood glucose, and blood pressure. Each component and the overall score range from 0 to 100 points, with higher scores indicating better cardiovascular health.
Mean Change From Baseline in Mediterranean Lifestyle Index Score at 24 Months
Adherence to the Mediterranean lifestyle will be assessed using the 28-item Mediterranean Lifestyle Index (MEDLIFE), which evaluates Mediterranean food consumption, Mediterranean dietary habits, physical activity, rest, and social interaction. Each item is scored as 0 or 1, producing an overall score ranging from 0 to 28 points. Higher scores indicate greater adherence to a Mediterranean lifestyle.
Mean Change From Baseline in Mediterranean Diet Adherence Screener Score at 24 Months
Adherence to the Mediterranean diet will be assessed using the 14-item Mediterranean Diet Adherence Screener (MEDAS). Each item contributes 0 or 1 point, resulting in a total score ranging from 0 to 14 points. Higher scores indicate greater adherence to the Mediterranean dietary pattern.
Mean Change From Baseline in Physical Activity at 24 Months
Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ), a validated self-reported instrument evaluating physical activity performed during the previous seven days. A physical activity score will be derived according to the standardized IPAQ scoring procedure, with higher values indicating a greater level of physical activity.
Mean Change From Baseline in Life's Essential 8 Score at 24 Months by Baseline Chronotype
Baseline chronotype will be assessed using the Morningness-Eveningness Questionnaire. The questionnaire score ranges from 16 to 86 points, with higher scores indicating a greater morning preference. Participants will be classified as having a morning, intermediate, or evening chronotype according to prespecified scoring criteria. Mean change in the Life's Essential 8 score from baseline to 24 months will be evaluated within each chronotype category to determine whether the effect of the digital intervention on cardiovascular health differs according to baseline chronotype.
Association of Circadian Health Parameters With Baseline Life's Essential 8 Score and Its Change at 24 Months
Circadian health will be assessed once during a seven-day monitoring period conducted within the first months after enrollment using the KronoWise KW-5 wrist-worn device. The device continuously records distal skin temperature, motor activity, wrist position, light exposure, and sleep-wake patterns. Prespecified parameters derived from these signals will be used to characterize circadian timing, amplitude, regularity, fragmentation, and sleep. These circadian health parameters will be examined in relation to the baseline Life's Essential 8 score and prospectively in relation to the change in Life's Essential 8 score from baseline to 24 months.
Mean Change From Baseline in Life's Essential 8 Score at 24 Months by Sex
Mean change in the Life's Essential 8 score from baseline to 24 months will be evaluated separately according to sex recorded at baseline. The overall score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health. Differences in the effect of the digital intervention according to sex will be assessed using a prespecified interaction analysis.
Mean Change From Baseline in Life's Essential 8 Score at 24 Months by Age Group
Mean change in the Life's Essential 8 score from baseline to 24 months will be evaluated according to four prespecified age groups: adolescents aged 12 to 19 years, young adults aged 20 to 39 years, middle-aged adults aged 40 to 64 years, and older adults aged 65 to 79 years. These categories are based on the age ranges used in American Heart Association population analyses of Life's Essential 8. The overall score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health. Differences in the effect of the digital intervention across age groups will be assessed using a prespecified interaction analysis.
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