Educational Strategy on a Vulnerable Population to Improve Cardiovascular Health and Food Insecurity (E-DUCASS)

March 24, 2026 updated by: Maimónides Biomedical Research Institute of Córdoba

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

460

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Córdoba, Spain
        • Reina Sofia University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants from the general population without disabling diseases or whose severity implies a life expectancy of less than five years
  • Informed Consent

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1- Non-intervention
Non-posterior intervention after randomization
Active Comparator: 2- Traditional advanced intervention model
Motivational workshops, every 3 months and with limited cost
Other: Education on a healthy lifestyle and health literacy
Traditional motivational face-to-face workshops with lifestyle (nutritional, physical activity, sleep) advice every 3 months
Other: Education on a healthy lifestyle and health literacy
E-learning and digital (with videos -YouTube channel or WhatsApp/text message) educational workshops with lifestyle (nutritional, physical activity, sleep) advice every 15 days
Active Comparator: 3- E-learning advanced intervention model
Educational workshops, every 15 days, with videos -YouTube channel or WhatsApp/text message
Other: Education on a healthy lifestyle and health literacy
Traditional motivational face-to-face workshops with lifestyle (nutritional, physical activity, sleep) advice every 3 months
Other: Education on a healthy lifestyle and health literacy
E-learning and digital (with videos -YouTube channel or WhatsApp/text message) educational workshops with lifestyle (nutritional, physical activity, sleep) advice every 15 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months
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).
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Collaborators

Carlos III Health Institute

Investigators

  • Principal Investigator: Pablo Pérez Martínez, PhD MD, Maimonides Institute for Biomedical Research in Cordoba (IMIBIC), Reina Sofia University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

June 15, 2024

Study Completion (Actual)

June 15, 2024

Study Registration Dates

First Submitted

May 13, 2022

First Submitted That Met QC Criteria

May 13, 2022

First Posted (Actual)

May 18, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI20/01413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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