Overview
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.
Description
e-DUCASS Advance is a 24-month, parallel-group, cluster-randomized controlled trial designed to evaluate the effectiveness of an enhanced digital health literacy intervention for improving cardiovascular health among people with different socioeconomic backgrounds in Córdoba, Spain. Participants are recruited from across the city.
The household is the unit of randomization, ensuring that all participating members of the same household are assigned to the same trial arm and reducing the risk of contamination between groups. Households are randomized in a 1:1 ratio to the control or digital intervention group using stratified permuted block randomization.
Randomization is stratified by socioeconomic status and household composition, resulting in six strata. Household composition is classified into three categories: households with children, households comprising two or more adults without children, and single-person households. Socioeconomic status is categorized as high or low-middle. Households within the upper income quintile of the municipal distribution for Córdoba, based on the 2023 Household Income Distribution Atlas of the Spanish National Statistics Institute, are classified as high income. All remaining households are classified within the low-middle-income category.
The randomization sequence was generated by an independent statistical programmer using the blockrand package, version 1.5, in R statistical software, version 4.4.2. Allocation was centralized, and researchers responsible for participant recruitment were unaware of the block sizes and upcoming assignments. Randomization was implemented in three successive waves as recruitment progressed, following a prespecified master randomization log.
After the baseline clinical and sociodemographic assessment, all participants receive an initial basic health education workshop addressing healthy eating, physical activity, sleep, tobacco use, and other cardiovascular health-related behaviors. Participants assigned to the control group receive no further structured educational intervention. Participants assigned to the digital intervention group receive weekly educational content through a web-based application or messaging channels for 24 months.
The digital intervention is based on three components: education, evaluation, and motivation. Educational materials include short videos and infographics with practical and accessible messages about cardiovascular health and healthy lifestyles. Brief assessments are used to reinforce knowledge and monitor engagement. Motivational activities, participation feedback, and access to support are intended to encourage sustained interaction with the program and the adoption of healthier behaviors.
Participants undergo study assessments at baseline, 12 months, and 24 months. These assessments include clinical history, anthropometric measurements, blood pressure, body composition, and biochemical measurements. Cardiovascular health is evaluated using the American Heart Association's Life's Essential 8 score, ranging from 0 to 100 and comprising diet, physical activity, nicotine exposure, sleep health, body mass index, blood lipids, blood glucose, and blood pressure.
The primary objective is to compare changes in Life's Essential 8 between the digital intervention and control groups and to examine whether the effect of the intervention differs according to household socioeconomic status. Secondary objectives include evaluating changes in adherence to a Mediterranean lifestyle, health and nutrition literacy, dietary habits, physical activity and sedentary behavior, chronotype, quality of life, anxiety, and depression. Potential differences according to age and sex will also be explored.
The target enrollment is approximately 600 participants aged 12 to 79 years. The sample size calculation accounts for household-level clustering and expected losses to follow-up. Longitudinal analyses will account for repeated measurements and the clustering of participants within households.
Eligibility
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.
