MedDataX Logo

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

NCT ID: NCT05379842

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Health Food Insecurity Healthy Lifestyle Vulnerable Population

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1- Non-intervention

Non-posterior intervention after randomization

Group Type NO_INTERVENTION

No interventions assigned to this group

2- Traditional advanced intervention model

Motivational workshops, every 3 months and with limited cost

Group Type ACTIVE_COMPARATOR

Education on a healthy lifestyle and health literacy

Intervention Type OTHER

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

3- E-learning advanced intervention model

Educational workshops, every 15 days, with videos -YouTube channel or WhatsApp/text message

Group Type ACTIVE_COMPARATOR

Education on a healthy lifestyle and health literacy

Intervention Type OTHER

E-learning and digital (with videos -YouTube channel or WhatsApp/text message) educational workshops with lifestyle (nutritional, physical activity, sleep) advice every 15 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Education on a healthy lifestyle and health literacy

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Carlos III Health Institute

OTHER_GOV

Sponsor Role collaborator

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pablo Pérez Martínez, PhD MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Reina Sofia University Hospital

Córdoba, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type 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.

Reference Type DERIVED
PMID: 40082777 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PI20/01413

Identifier Type: -

Identifier Source: org_study_id