Educational Strategy on a Vulnerable Population to Improve Cardiovascular Health and Mitigate Food Insecurity Through a Sustainable Health Literacy Program
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Cardiovascular Health
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants from the general population without disabling diseases or whose severity implies a life expectancy of less than five years
- •Informed Consent
排除标准
- •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.
结局指标
主要结局
Cardiovascular Health
时间窗: 24 months
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.
Food insecurity
时间窗: 24 months
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).
次要结局
未报告次要终点