Healthy Lifestyle Clinical Trial
— E-DUCASSOfficial title:
Educational Strategy on a Vulnerable Population to Improve Cardiovascular Health and Mitigate Food Insecurity Through a Sustainable Health Literacy Program
Verified date | December 2023 |
Source | Maimónides Biomedical Research Institute of Córdoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 460 |
Est. completion date | June 15, 2024 |
Est. primary completion date | June 15, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Reina Sofia University Hospital | Cordoba |
Lead Sponsor | Collaborator |
---|---|
Maimónides Biomedical Research Institute of Córdoba | Carlos III Health Institute |
Spain,
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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