Impact of a Pedagogical Intervention on Children Cardiovascular Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 870
- 试验地点
- 1
- 主要终点
- Change in active energy expenditure in children
研究概览
简要总结
In Bogotá, Colombia, the Fundación Cadioinfantil performed a randomized and controlled community trial, to evaluate the impact of a pedagogical intervention (PI) on cardiovascular health towards an active lifestyle and healthy eating in 9 schools of the city, including children from kindergarten to second grade of elementary school, their parents and teachers.
详细描述
Cardiovascular disease (CVD) is a leading cause of mortality worldwide and Colombia is not an exception. Epidemiological studies have demonstrated that CVD risk factors are identifiable in childhood and they are predictor of CDV risk in adulthood. Worldwide, CDV primary prevention that begins in childhood is identified as a strategy that decreases the burden of this disease.
Programs developed in educational communities (EC), that include in their planning and implementation students, teachers and parents, with training to food personnel, are the most effective strategies to create healthy school environments and reduce the burden of chronic diseases. However recent studies that evaluate physical activity through accelerometers have not shown effectiveness.
In 2009, the Si! program and Fundación CardioInfantil performed a randomized and controlled community trial in facilities of the Colombian Family welfare Institute, ICBF, from Usaquen locality in Bogotá, finding that a pedagogical intervention (PI) in preschool children, their parents and teachers is effective in improving knowledge, attitudes and habits towards an active lifestyle and healthy diet.
The construction of the proposed intervention is based on the best available evidence about programs, policies and practices that positively impact in healthy eating and physical activity habits in EC.
The objectives of this project are to evaluate changes in healthy foods consumption and energy expenditure in children from kindergarten to second grade of elementary school that receives pedagogical intervention (PI) adapted to its context, compared to another EC that develops its habitual curriculum. In addition, this study evaluates changes on cardiovascular risk factors in children. Also, it evaluates changes in healthy foods consumption in their parents and teachers.
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
- None
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Private schools located in the urban area of Bogotá
- •Schools with an appropriate physical activity space and infrastructure.
- •Schools that allow the study conduction.
排除标准
- •Schools that have received interventions of more than 1 month in healthy habits (nutrition and / or physical activity) during the year prior to the start of the study.
- •Schools that plan to receive interventions of more than 1 month in healthy habits (nutrition and / or physical activity) during the time of follow-up of the study.
- •Schools with a history of annual dropout of their students or teachers greater than 10%.
研究组 & 干预措施
Investigational
An education intervention was implemented in 5 schools including 516 children, 360 parents and 240 teachers.
The Pedagogical Intervention last two and a half years. In children, the intervention included class activities (1/week) and the use of educational materials for the development of pedagogical activities (posters and educative guide).
In parents included 3 workshops/year (2 hours each) about the areas of the intervention; sending healthy notes (1/month) and celebration of healthy family day (1/year).
In teachers included 3 workshops/year (2 hours each) about the areas of the intervention; planning and realization of pedagogical activities to develop with the students (1/week) and follow-up visits to school (1/month).
干预措施: Investigational (Other)
Control
The control group consisted of 4 schools including 354 children, 305 parents and 110 teachers.
The activities in control group last two and a half years. Children received the standard curriculum in health and physical activity of the national Ministry of Education.
In parents and teachers included 3 workshops/year (2 hours each) about the first aid and accident prevention.
干预措施: Control (Other)
结局指标
主要结局
Change in active energy expenditure in children
时间窗: Baseline and 2.5 years
The energy expenditure (Kilocalories/day), in children from Kindergarten to grade 2 of elementary school, generated by physical activity was evaluated using accelerometers during 4 consecutive days, 24hours/day (2 weekend days and two schooldays) through an Actiheart® 4 type accelerometer. Possible differences between changes in active energy expenditure means was assessed using test t-test. Multi-variable models were performed to adjust for potential con-founders.
Changes in healthy foods consumption in children
时间窗: Baseline and 2.5 years
A food frequency survey (ENSIN 2010) was used in children from Kindergarten to grade 2 of elementary school. Healthy foods consumptions were defined as the accomplishment of 3-4 of the 4 measured components (intake of Fruits and vegetables ≥3 times a day, Fiber: ≥3 times a day, Fish: ≥2 times a week, Sugary beverages: ≤ 1 time a day). Possible differences between changes in the proportion of children with healthy foods consumption was assessed using chi2 test. Multi-variable models were performed to adjust for potential con-founders.
次要结局
- Changes in the Body Mass Index in children(Baseline and 2.5 years)
- Changes in the perimeter of the waist in children(Baseline and 2.5 years)
- Changes in fasting glycemia in children(Baseline and 2.5 years)
- Change in blood pressure in children(Baseline and 2.5 years)
- Changes in the consumption of healthy foods in teachers(Baseline and 2.5 years)
- Changes in total cholesterol in children(Baseline and 2.5 years)
- Changes in triglycerides in children(Baseline and 2.5 years)
- Changes in the consumption of healthy foods in parents(Baseline and 2.5 years)
研究者
CespedesJ_PI
Head of the Pediatric Service
Fundación Cardioinfantil Instituto de Cardiología