A Cluster-Randomized Clinical Trial Of Two Educational Strategies In Cardiovascular Health (CVH) In Child Population. The Savinghearts Project
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,730
- 试验地点
- 2
- 主要终点
- Change in Knowledge and attitudes in Cardiovascular Health
研究概览
简要总结
AIM: To evaluate the effectiveness of two strategies in cardiovascular risk in children 2º grade in the community of Madrid.
DESIGN: cluster-randomized trial with blinded evaluator SCOPE AND SUBJECTS OF STUDY: Children of both sexes enrolled in 2º grade in public schools in the community of Madrid. Rate exclusion criteria INTERVENTION: Schools were randomly assigned to two groups: an experimental group that the investigators organized a concert teaching focused on messages cardio, a second group or control group to which they will host a healthy breakfast as it has been offering the Community of Madrid .
MEASUREMENTS: The primary end result is the increase of correct answers on a standardized test to be administered before and after the activity.
Secondary outcomes will be, improving the same questionnaire at 6 months and reduced overall weight and center from before the intervention at 6 months of it.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2º grade of primary school students present the day of the activity, whose parents had signed the informed consent to participate in the study and with no
排除标准
- •at the moment of the intervention
- •Exclusion Criteria:
- •Students with food allergies or intolerances.
- •Students with severe hearing impairment (not corrected).
- •Students whose parents didn´t sign the informed consent to participate in the study.
- •Students with a poor understanding of oral and written language.
- •To have previously received healthy breakfasts interventions or educational concerts.
结局指标
主要结局
Change in Knowledge and attitudes in Cardiovascular Health
时间窗: Before the intervention (baseline) and 7 days after and 6 months after the intervention.
The primary outcome variable will be the changes in healthy heart knowledge and attitudes in children in 2º grade of primary school. We will measure this primary outcome variable using 2 modified INUTCAM questionnaires
次要结局
- Body Mass Index (BMI)(before the intervention (baseline) and 6 months after them.)
研究者
Blanca Novella
Médico familia SERMAS
Agencia Lain Entralgo