Cardiovascular HealthE-DUCASSNCT05379842
Educational Strategy on a Vulnerable Population to Improve Cardiovascular Health and Food Insecurity
A study testing Education on a healthy lifestyle and health literacy in people with Cardiovascular Health and Food Insecurity, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
The purpose of this study is to demonstrate that an educational program on a healthy lifestyle which increases health literacy could improve long-term health and mitigate food insecurity. Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health, Food Insecurity, Healthy Lifestyle
- What is being tested?
- Education on a healthy lifestyle and health literacy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2021to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants from the general population without disabling diseases or whose severity implies a life expectancy of less than five years
- Informed Consent
Who cannot join
- Age less than 12 years or equal to or greater than 80 years, with a life expectancy, not less than 5 years.
- Patients with established cardiovascular disease
- Patients with limitations to follow the protocol
- Serious or difficult-to-control risk factors: Patients with hypertension and diabetes with organic involvement that limits their survival and disabling clinical manifestations of cerebral arteriosclerosis will be excluded.
- Chronic diseases not related to coronary risk: severe psychiatric diseases, chronic processes requiring treatment such as chronic renal failure, chronic liver disease, neoplasms undergoing treatment, severe and very severe chronic obstructive pulmonary disease, endocrinopathies susceptible to decompensation, and digestive tract diseases.
- Participants in other clinical trials at screening or within 30 days prior to start.
- Excessive alcohol and drug abuse
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Educational Strategy on a Vulnerable Population to Improve Cardiovascular Health and Mitigate Food Insecurity Through a Sustainable Health Literacy Program
The purpose of this study is to demonstrate that an educational program on a healthy lifestyle which increases health literacy could improve long-term health and mitigate food insecurity.
Read the detailed description
A 24-month randomized clinical trial involving vulnerable families (460 participants) at risk of food insecurity to improve cardiovascular health, with an initial basic training workshop followed by randomization into three groups: 1. No further intervention; 2. A traditional advanced intervention model every three months; and 3. E-learning advanced intervention model every 15 days with YouTube videos and WhatsApp messages.
Primary objective:
- Improve cardiovascular health measured by Life's Simple 7, American Heart Association
Secondary objective
- Demonstrate whether the intervention improves the food safety score measured according to FAO
- Study which of the two models of advanced intervention, face-to-face or virtual, improves cardiovascular and food health literacy in the study population.
This project aims to transfer and offer to society this virtual educational strategy as a tool to improve cardiovascular health in other vulnerable populations, in a scientific, efficient, safe, and sustainable way.
- Being tested
- Education on a healthy lifestyle and health literacy
- Keywords
- Food insecurity, Educational program, Health Literacy, Cardiovascular Health, E-learning, Healthy Planetary Food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education on a healthy lifestyle and health literacyOther
Traditional motivational face-to-face workshops with lifestyle (nutritional, physical activity, sleep) advice every 3 months
Education on a healthy lifestyle and health literacyOther
E-learning and digital (with videos -YouTube channel or WhatsApp/text message) educational workshops with lifestyle (nutritional, physical activity, sleep) advice every 15 days
| Study group | Role | What they receive |
|---|---|---|
| 1- Non-intervention | No intervention | Non-posterior intervention after randomization |
| 2- Traditional advanced intervention model | Active comparator | Motivational workshops, every 3 months and with limited cost Receives: Other: Education on a healthy lifestyle and health literacy |
| 3- E-learning advanced intervention model | Active comparator | Educational workshops, every 15 days, with videos -YouTube channel or WhatsApp/text message Receives: Other: Education on a healthy lifestyle and health literacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Health
Improve cardiovascular health measured by Life's Simple 7 (LS7) score. LS7 score is composed of seven domains (diet, physical activity, body mass index, smoking, blood pressure, total cholesterol and fasting blood glucose). Each of seven domains were ranged from 0 poor to 2 ideal. The total score of LS7 ranged from 0-14 with higher scores indicating better cardiovascular health.
Measured: 24 months
Food insecurity
Improve food insecurity measured by The Food Insecurity Experience Scale Survey Module (FIES-SM) from Food and Agriculture Organization of the United Nations. FIES-SM is composed of eight questions with dichotomous no (0 points)/ yes (1 point) responses. The final score ranged from 0 (no insecurity food) to 8 (worst insecurity food).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Dec 2021
- Primary completion15 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute
- Responsible party
- Sponsor
- Investigators
- Pablo Pérez Martínez, PhD MD, Principal investigator, Maimonides Institute for Biomedical Research in Cordoba (IMIBIC), Reina Sofia University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379842
- Sponsor's protocol ID
- PI20/01413
- Acronym
- E-DUCASS
- Status last verified
- Mar 2026
- First submitted
- 13 May 2022
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Romero-Cabrera, Juan L.; de-Castro-Burón, Isabel; Yubero-Serrano, Elena; Díaz-Cáceres, Alberto; Serrán-Jiménez, Alejandro; Arenas-Montes, Javier; Alcalá-Díaz, Juan F.; Ortiz-Morales, Ana; Pérez-Martínez, Pablo. (2022). Educational strategy to improve cardiovascular health and mitigate food insecurity: Rationale for the E-DUCASS program. Spanish Journal of Medicine. 2. 10.24875/SJMED.21000025.
Porras-Perez E, Romero-Cabrera JL, Diaz-Caceres A, Serran-Jimenez A, Arenas-Montes J, Pena-Orihuela PJ, De-Castro-Buron I, Garcia-Rios A, Torres-Pena JD, Malagon MM, Delgado-Lista J, Ordovas JM, Yubero-Serrano EM, Perez-Martinez P. Food Insecurity and Its Cardiovascular Implications in Underresourced Communities. J Am Heart Assoc. 2025 Mar 18;14(6):e037457. doi: 10.1161/JAHA.124.037457. Epub 2025 Mar 13.
PubMed 40082777
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Strategy on a Vulnerable Population to Improve Cardiovascular Health and Mitigate Food Insecurity Through a Sustainable Health Literacy Program
- ClinicalTrials.gov ID
- NCT05379842
- Acronym / sponsor ID
- E-DUCASS / PI20/01413
- Keywords
- Food insecurity, Educational program, Health Literacy, Cardiovascular Health, E-learning, Healthy Planetary Food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Collaborators
- Carlos III Health Institute
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that an educational program on a healthy lifestyle which increases health literacy could improve long-term health and mitigate food insecurity.
Detailed description
A 24-month randomized clinical trial involving vulnerable families (460 participants) at risk of food insecurity to improve cardiovascular health, with an initial basic training workshop followed by randomization into three groups: 1. No further intervention; 2. A traditional advanced intervention model every three months; and 3. E-learning advanced intervention model every 15 days with YouTube videos and WhatsApp messages.
Primary objective:
- Improve cardiovascular health measured by Life's Simple 7, American Heart Association
Secondary objective
- Demonstrate whether the intervention improves the food safety score measured according to FAO
- Study which of the two models of advanced intervention, face-to-face or virtual, improves cardiovascular and food health literacy in the study population.
This project aims to transfer and offer to society this virtual educational strategy as a tool to improve cardiovascular health in other vulnerable populations, in a scientific, efficient, safe, and sustainable way.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1- Non-intervention | No intervention | –Non-posterior intervention after randomization |
| 2- Traditional advanced intervention model | Active comparator | Other: Education on a healthy lifestyle and health literacyMotivational workshops, every 3 months and with limited cost |
| 3- E-learning advanced intervention model | Active comparator | Other: Education on a healthy lifestyle and health literacyEducational workshops, every 15 days, with videos -YouTube channel or WhatsApp/text message |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participants from the general population without disabling diseases or whose severity implies a life expectancy of less than five years
- Informed Consent
Key exclusion criteria (8 listed)
- Age less than 12 years or equal to or greater than 80 years, with a life expectancy, not less than 5 years.
- Patients with established cardiovascular disease
- Patients with limitations to follow the protocol
- Serious or difficult-to-control risk factors: Patients with hypertension and diabetes with organic involvement that limits their survival and disabling clinical manifestations of cerebral arteriosclerosis will be excluded.
- Chronic diseases not related to coronary risk: severe psychiatric diseases, chronic processes requiring treatment such as chronic renal failure, chronic liver disease, neoplasms undergoing treatment, severe and very severe chronic obstructive pulmonary disease, endocrinopathies susceptible to decompensation, and digestive tract diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education on a healthy lifestyle and health literacyTraditional motivational face-to-face workshops with lifestyle (nutritional, physical activity, sleep) advice every 3 months | Other | 2- Traditional advanced intervention model |
| Education on a healthy lifestyle and health literacyE-learning and digital (with videos -YouTube channel or WhatsApp/text message) educational workshops with lifestyle (nutritional, physical activity, sleep) advice every 15 days | Other | 3- E-learning advanced intervention model |
Primary outcome
Cardiovascular Health
Time frame: 24 months
Improve cardiovascular health measured by Life's Simple 7 (LS7) score. LS7 score is composed of seven domains (diet, physical activity, body mass index, smoking, blood pressure, total cholesterol and fasting blood glucose). Each of seven domains were ranged from 0 poor to 2 ideal. The total score of LS7 ranged from 0-14 with higher scores indicating better cardiovascular health.
Food insecurity
Time frame: 24 months
Improve food insecurity measured by The Food Insecurity Experience Scale Survey Module (FIES-SM) from Food and Agriculture Organization of the United Nations. FIES-SM is composed of eight questions with dichotomous no (0 points)/ yes (1 point) responses. The final score ranged from 0 (no insecurity food) to 8 (worst insecurity food).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- BackgroundRomero-Cabrera, Juan L.; de-Castro-Burón, Isabel; Yubero-Serrano, Elena; Díaz-Cáceres, Alberto; Serrán-Jiménez, Alejandro; Arenas-Montes, Javier; Alcalá-Díaz, Juan F.; Ortiz-Morales, Ana; Pérez-Martínez, Pablo. (2022). Educational strategy to improve cardiovascular health and mitigate food insecurity: Rationale for the E-DUCASS program. Spanish Journal of Medicine. 2. 10.24875/SJMED.21000025.
- Derived from this study: PubMed 40082777Porras-Perez E, Romero-Cabrera JL, Diaz-Caceres A, Serran-Jimenez A, Arenas-Montes J, Pena-Orihuela PJ, De-Castro-Buron I, Garcia-Rios A, Torres-Pena JD, Malagon MM, Delgado-Lista J, Ordovas JM, Yubero-Serrano EM, Perez-Martinez P. Food Insecurity and Its Cardiovascular Implications in Underresourced Communities. J Am Heart Assoc. 2025 Mar 18;14(6):e037457. doi: 10.1161/JAHA.124.037457. Epub 2025 Mar 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Pérez Martínez, PhD MD principal investigator
Maimonides Institute for Biomedical Research in Cordoba (IMIBIC), Reina Sofia University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education on a healthy lifestyle and health literacy in people with Cardiovascular Health and Food Insecurity, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Health (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05379842, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.