跳至主要内容
临床试验/NCT05630924
NCT05630924终止不适用

Children's Lifestyle, Diet, and Exercise Intervention - CHILDREN's Project

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 1,294 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1,294
试验地点
1
主要终点
Adapted Ideal Cardiovascular Health Score (ICH)

研究概览

简要总结

Cluster randomized trial to evaluate the impact of a health promotion intervention (the SI! - Program NYC) on the adapted Ideal Cardiovascular Health score (aICH) in children enrolled in New York City elementary schools.

详细描述

Cluster randomized trial to evaluate the impact of a health promotion intervention (the SI! - Program NYC) on the adapted Ideal Cardiovascular Health score (aICH) in children enrolled in New York City elementary schools. This study will enroll children of ages 5 to 6 and teachers from participating schools. Participating schools will be randomized to an intervention group or a control (non-intervention group). The SI! Program intervention will incorporate a comprehensive vision of cardiovascular health promotion that encompasses four basic components: body and heart, physical activity, healthy diet, and emotional management. The intervention will take place at baseline and a reintervention will take place at 2 years-follow up. The research team will assess an adapted version of the Ideal Cardiovascular Health (aICH) score (that includes body-mass-index Z-score, physical activity, diet, sleep time and smoking exposure) and the Knowledge, Attitudes, and Habits (KAH) score. The aICH will be evaluated at baseline, 2 years and 4 years follow-up; the KAH will be evaluated at baseline and after the first intervention, and prior and after the second intervention. The research team will also study the influence of factors in parents (socioeconomic and health-related variables), teachers (stress, teaching motivation, and health status), and the environment (pollution, housing, and neighborhood conditions) through parent/caregiver questionnaires, teacher questionnaires, publicly available data, and pollution data sourced from NASA satellites.

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 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • NYC Elementary school Kindergarten Children
  • Parents and teachers of participating children

排除标准

  • Children who are Wards of the State
  • Children or parents who cannot provide legally effective consent

结局指标

主要结局

Adapted Ideal Cardiovascular Health Score (ICH)

时间窗: 4 years

The adapted ideal cardiovascular health score (ICH) includes 5 components: body-mass-index Z-score, physical activity, diet, sleep/screen time, and passive smoking status. The score will be calculated for five factors on a 0 to 100 scale, according to pre-defined, age adjused cut-offs recommended by the American Heart Association. Higher values represent better health outcomes.

次要结局

  • Knowledge, Attitudes, and Habits Score(2 years and 4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Valentin Fuster

President of Mount Sinai Heart and Chairman

Icahn School of Medicine at Mount Sinai

研究点 (1)

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