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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Food Insecurity, Healthy Lifestyle, Vulnerable Population, Cardiovascular Health

Intervention / Treatment
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* Other: Education on a healthy lifestyle and health literacy
* Other: Education on a healthy lifestyle and health literacy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1- Non-intervention<br>Non-posterior intervention after randomization | |
| Active Comparator: 2- Traditional advanced intervention model<br>Motivational workshops, every 3 months and with limited cost | Other: Education on a healthy lifestyle and health literacy<br>* Traditional motivational face-to-face workshops with lifestyle (nutritional, physical activity, sleep) advice every 3 months<br>|
| Active Comparator: 3- E-learning advanced intervention model<br>Educational workshops, every 15 days, with videos -YouTube channel or WhatsApp/text message | Other: Education on a healthy lifestyle and health literacy<br>* E-learning and digital (with videos -YouTube channel or WhatsApp/text message) educational workshops with lifestyle (nutritional, physical activity, sleep) advice every 15 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food insecurity, Educational program, Health Literacy, Cardiovascular Health, E-learning, Healthy Planetary Food