跳至主要内容
临床试验/NCT05521490
NCT05521490招募中不适用

Combating Physical Inactivity Pandemic by Promoting Physical Fitness Education and Physical Activity-Embedded Curriculum in Kindergartens

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 3,300 人开始时间: 2022年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
3,300
试验地点
1
主要终点
Change in Cardiorespiratory Fitness

研究概览

简要总结

The aim of this study is to examine the effects of a kindergarten-based, parent-involved intervention during the upper kindergarten year (K3) on physical activity and physical fitness in preschool children.

详细描述

This study is a two-arm cluster randomized controlled trial. Kindergartens will be randomly allocated to two groups: the usual care group and the intervention group. The usual care group will continue with their usual curriculum, which includes 30 minutes of daily physical activity stipulated by the Hong Kong SAR Government's Education Bureau. The intervention group will receive an additional 2.5 hours of physical activity per week in addition to the stipulated 30 minutes of daily physical activity. Outcome measures will be examined at baseline, 10 months (post-intervention), and 16 months (follow-up).

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
5 Years 至 6 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children aged 5-6 years (limited number of children may be between 4-5 and 6-7 years)
  • •Able to communicate in Chinese
  • •Able to participate in physical activity in a standard kindergarten setting

排除标准

  • •Inherent or serious disease limiting participation in physical activity (e.g., congenital heart disease, pediatric cancer, Down syndrome).
  • •Diagnosed mental illness impairing daily behavior and performance (e.g., anxiety disorder, depression, attention deficit hyperactivity disorder, psychotic disorders, autism spectrum disorder).
  • •Physical disability (e.g., physical handicap, assistive device to walk).
  • •Visual or hearing impairment.
  • •Cognitive deficit or intellectual disability that requires special care and educational needs (e.g., handicapped children with learning difficulties).

研究组 & 干预措施

Usual Care Control

Other

Children allocated to the control group will continue with their usual curriculum, which includes the stipulated 30 minutes of daily physical activity.

干预措施: Usual Care Control (Other)

Physical Activity Enhanced Curriculum

Experimental

Children allocated to the intervention group will receive enhanced physical fitness and healthy lifestyle education and a physical activity enhanced curriculum during their school year.

干预措施: Physical Activity Enhanced Curriculum (Behavioral)

结局指标

主要结局

Change in Cardiorespiratory Fitness

时间窗: Baseline and 10 months

Cardiorespiratory fitness will be assessed using the 20-meter shuttle run test.

Change in Physical Activity

时间窗: Baseline and 10 months

Physical activity will be assessed using an actigraph device with a three-axis accelerometer.

次要结局

  • Change in Body Mass Index(Baseline, 10 months, and 16 months)
  • Change in Cardiorespiratory Fitness(Baseline and 16 months)
  • Change in Muscle Power(Baseline, 10 months, and 16 months)
  • Change in Physical Activity(Baseline and 16 months)
  • Change in Agility(Baseline, 10 months, and 16 months)
  • Change in Theory of Planned Behavior Scale Score(Baseline, 10 months, and 16 months)
  • Change in Sedentary Behavior and Screen Time(Baseline, 10 months, and 16 months)
  • Change in Muscular Strength(Baseline, 10 months, and 16 months)
  • Change in Waist Circumference(Baseline, 10 months, and 16 months)
  • Change in Flexibility(Baseline, 10 months, and 16 months)
  • Change in Balance Ability(Baseline, 10 months, and 16 months)
  • Change in Body Fat(Baseline, 10 months, and 16 months)
  • Change in Fat-Free Mass(Baseline, 10 months, and 16 months)
  • Change in Kiddy-KINDL(Baseline, 10 months, and 16 months)
  • Change in Early Development Instrument(Baseline, 10 months, and 16 months)
  • Change in Treatment Self-Regulation Questionnaire Score(Baseline, 10 months, and 16 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验