RECRUITING Not applicable ClinicalTrials.gov

Digital Health Education to Improve Cardiovascular Health Across Different Socioeconomic Groups: e-DUCASS Advance

Sponsor: Maimónides Biomedical Research Institute of Córdoba • ClinicalTrials.gov ID: NCT07835386

Registry updated: 2026-09-22

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Description

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.

Interventions

Enhanced Digital Health Literacy Program (Behavioral)
The 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.

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Conditions

Cardiovascular Health Health Literacy

Locations

Instituto Maimónides de Investigación Biomédica de Córdoba — Córdoba, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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