Educational Strategy on a Vulnerable Population to Improve Cardiovascular Health and Food Insecurity (E-DUCASS)

Maimónides Biomedical Research Institute of Córdoba

Status: Active, not recruiting

Conditions: Healthy Lifestyle; Cardiovascular Health; Vulnerable Population; Food Insecurity

Treatments: Other: Education on a healthy lifestyle and health literacy

Study type: Interventional

Funder types: Other

Identifiers

NCT05379842

PI20/01413

Details and patient eligibility

About

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.

Full 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.

Enrollment: 460 patients

Sex: All

Ages: 12 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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460 participants in 3 patient groups

1- Non-intervention

No Intervention group

Description:

Non-posterior intervention after randomization

2- Traditional advanced intervention model

Active Comparator group

Description:

Motivational workshops, every 3 months and with limited cost

Treatment:

Other: Education on a healthy lifestyle and health literacy

Other: Education on a healthy lifestyle and health literacy

3- E-learning advanced intervention model

Active Comparator group

Description:

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

Treatment:

Other: Education on a healthy lifestyle and health literacy

Other: Education on a healthy lifestyle and health literacy