Children Education as Therapeutic Instrument for Cardiovascular Risk Reduction in Their Parents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 2
- 主要终点
- Changes in cardiovascular risk measured by Framingham score index in parents whose children have participated (or not) in a multidisciplinary educational intervention for prevention of cardiovascular diseases.
研究概览
简要总结
This study aims to evaluate if a multidisciplinary educational program in primary cardiovascular prevention for children could improve the Framingham Score index of their parents after one year.
详细描述
Students aging 6 to 10 years old were exposed to two different approaches in the city of Sao Paulo, Brazil. For the students of the morning period (control group) we delivered written educational material for their parents in the beginning and middle of the year 2010 about healthy lifestyle (nutrition, exercise and smoke quitting). The students of the afternoon period (intervention group) received the same educational material for their parents and the children were exposed to a weekly educational program in cardiovascular prevention with a multidisciplinary heath team during the year 2010. This intervention tried to teach to these children, in different manners appropriate for their age, concepts of healthy nutrition, avoidance of tobacco and physical activity. Both at the inclusion in the study and one year later we collect data of parents and their children of the two groups, in a single weekend, including nutritional and exercise survey, measures of weigh, height, waist circumference, arterial blood pressure, and laboratorial exams.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •students aged 6 to 10 years old and their parents of a single private school of the city of Sap Paulo, Brazil
排除标准
- •children and/or parents that do not agree to participate of the study;
- •children and/or parents that are taking immunosupressive drugs;
- •parents with known atherosclerotic disease such as angina or myocardial infaction, stroke, and/or peripheral arterial disease;
- •parents with untreated hypothyroidism, untreated hypopituitarosm, nefrotic syndrome, chronic renal failure, congenital biliary allof, storage diseases, lupus and/oracquired immunodeficiency syndrome.
研究组 & 干预措施
Lifestyle counseling
Children received the same educational material for their parents and, additionaly, were exposed to a weekly educational program directed for cardiovascular prevention.
干预措施: Educational program in cardiovascular prevention (Behavioral)
Control group
The control group received written educational material directed for their parents and related to healthy lifestyle (nutrition, exercise and smoke quitting).
干预措施: Lifestyle counseling (Behavioral)
结局指标
主要结局
Changes in cardiovascular risk measured by Framingham score index in parents whose children have participated (or not) in a multidisciplinary educational intervention for prevention of cardiovascular diseases.
时间窗: Basal evaluation before intervention (basline) and one-year after intitiation of intervention program.
次要结局
未报告次要终点
研究者
Bruno Caramelli
Associated Professor of Cardiology
University of Sao Paulo