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

NCT07835386 | Recruiting

• 1 other identifier: PI24/00875
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Health; Health Literacy

Keywords

Life's Essential 8; Digital Health education; Cardiovascular disease prevention; Lifestyle intervention; Health equity; Social determinants of health

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 24 months

Secondary Outcomes (7)

• Mean Change From Baseline in Life's Essential 8 Score at 12 Months

  Baseline and 12 months

• Mean Change From Baseline in Mediterranean Lifestyle Index Score at 24 Months

  Baseline and 24 months

• Mean Change From Baseline in Mediterranean Diet Adherence Screener Score at 24 Months

  Baseline and 24 months

• Mean Change From Baseline in Physical Activity at 24 Months

  Baseline and 24 months

• Mean Change From Baseline in Patient Health Questionnaire-9 Score at 24 Months

  Baseline and 24 months

Other Outcomes (12)

• Mean Change From Baseline in Life's Essential 8 Score at 24 Months by Baseline Chronotype

  Baseline and 24 months

• Association of Circadian Health Parameters With Baseline Life's Essential 8 Score and Its Change at 24 Months

  Seven-day circadian monitoring during the first months after enrollment; Life's Essential 8 assessed at baseline and 24 months

• Mean Change From Baseline in Life's Essential 8 Score at 24 Months by Sex

  Baseline and 24 months

Study Arms (2)

Control group

NO INTERVENTION

No further intervention

Digital Intervention Group

EXPERIMENTAL

Participants receive the initial basic health education workshop provided to all study participants, followed by a 24-month enhanced digital health literacy intervention. Weekly educational content is delivered through a web-based application or messaging channels and includes short videos, infographics, brief knowledge assessments, motivational activities, participation feedback, and access to support. The content addresses healthy eating, physical activity, sleep, tobacco use, and other health-related behaviors aimed at improving cardiovascular health.

Behavioral: Enhanced Digital Health Literacy Program

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.

Also known as: e-DUCASS Advance Digital Intervention

Digital Intervention Group

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

Instituto Maimónides de Investigación Biomédica de Córdoba

Córdoba, 14004, Spain

RECRUITING

Study Officials

• Pablo Pérez Martínez, Professor, PhD, MD

  Instituto Maimónides de Investigación Biomédica de Córdoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

e-DUCASS Advance Study Team

CONTACT

+34 680 761 975; educass.advance@imibic.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and the staff responsible for delivering the digital intervention and coordinating study visits were aware of treatment allocation. Access to allocation information was restricted to the nutritionist responsible for the intervention content and participant contact and the research nurse responsible for visit coordination and biological sample collection. Investigators responsible for outcome evaluation and the statistical analysts remained blinded to treatment allocation. Study data were coded so that group assignment was concealed during outcome assessment and statistical analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm, parallel, cluster-randomized design. Households are randomized in a 1:1 ratio to the digital intervention or control group, with all participating members of the same household assigned to the same study arm. Randomization is stratified by household composition and socioeconomic status. Recruitment is conducted in three successive waves, but participants remain in their assigned study arm throughout the 24-month follow-up, with no crossover between groups.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 22, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): December 15, 2028
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 12 months after publication of the primary study results and remaining available for 5 years thereafter.
• Access Criteria: Access may be granted to qualified researchers affiliated with academic or public research institutions who submit a scientifically sound proposal for non-commercial research. Requests should be submitted to the study principal investigator and will be reviewed by the study investigators. Access will require approval of the proposed analyses, compliance with applicable ethical, institutional, and data-protection requirements, and execution of a data-use agreement prohibiting participant re-identification and unauthorized onward sharing. Approved researchers will receive only the deidentified individual participant data necessary for the approved purpose, together with the available supporting documentation, through a secure controlled-access mechanism.

Locations

ES (1)