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OpenTrials
Completed

NCT Number: NCT05379842

Educational Strategy on a Vulnerable Population to Improve Cardiovascular Health and Food Insecurity

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.

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Key information

Age range

12 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reina Sofia University Hospital

Córdoba, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education on a healthy lifestyle and health literacy

Other

Traditional motivational face-to-face workshops with lifestyle (nutritional, physical activity, sleep) advice every 3 months

Primary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Other

Collaborators

  • Carlos III Health Institute

Registry information

Official study title

Educational Strategy on a Vulnerable Population to Improve Cardiovascular Health and Mitigate Food Insecurity Through a Sustainable Health Literacy Program

Acronym: E-DUCASS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 18, 2022
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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