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

Healthy Lifestyle Clinical Trial

— E-DUCASS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05379842
• Other study ID #: PI20/01413
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: June 15, 2024

Study information

• Verified date: December 2023
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 460
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Health
• Food Insecurity
• Healthy Lifestyle
• Vulnerable Population

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	Reina Sofia University Hospital	Cordoba

Sponsors (2)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba	Carlos III Health Institute

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Primary	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).	24 months