Status:
UNKNOWN
Educational Strategy on a Vulnerable Population to Improve Cardiovascular Health and Food Insecurity
Lead Sponsor:
Maimónides Biomedical Research Institute of Córdoba
Collaborating Sponsors:
Carlos III Health Institute
Conditions:
Cardiovascular Health
Food Insecurity
Eligibility:
All Genders
12-80 years
Phase:
NA
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 r...
Eligibility Criteria
Inclusion
- Participants from the general population without disabling diseases or whose severity implies a life expectancy of less than five years
- Informed Consent
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2024
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT05379842
Start Date
December 1 2021
End Date
June 15 2024
Last Update
December 26 2023
Active Locations (1)
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1
Reina Sofia University Hospital
Córdoba, Spain