Clinical trial NCT05379842: Educational Strategy on a Vulnerable Population to Improve Cardiovascular Health and Food Insecurity
Official title: Educational Strategy on a Vulnerable Population to Improve Cardiovascular Health and Mitigate Food Insecurity Through a Sustainable Health Literacy Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Health
Food Insecurity
Healthy Lifestyle
Vulnerable Population
Keywords: Food insecurity
Educational program
Health Literacy
Cardiovascular Health
E-learning
Healthy Planetary Food
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
First posted: 2022-05-18
Enrollment: 460
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cardiovascular Health
timeFrame: 24 months
measure: Food insecurity
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: Reina Sofia University Hospital
Study officials:
affiliation: Maimonides Institute for Biomedical Research in Cordoba (IMIBIC), Reina Sofia University Hospital
name: Pablo Pérez Martínez, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.