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

NCT05379842 | Completed DMC

• 1 other identifier: PI20/01413
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulnerable Population; Cardiovascular Health; Food Insecurity; Healthy Lifestyle

Keywords

Food insecurity; Educational program; Health Literacy; Cardiovascular Health; E-learning; Healthy Planetary Food

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

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

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

Other: Education on a healthy lifestyle and health literacy

Interventions

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

2- Traditional advanced intervention model

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead
• Carlos III Health Institute: collaborator

Study Sites (1)

Reina Sofia University Hospital

Córdoba, Spain

Location

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  PMID: 40082777 DERIVED

MeSH Terms

Interventions

Health Literacy

Intervention Hierarchy (Ancestors)

Consumer Health Information; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Pablo Pérez Martínez, PhD MD

  Maimonides Institute for Biomedical Research in Cordoba (IMIBIC), Reina Sofia University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 18, 2022
• Study Start: December 1, 2021
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)