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临床试验/NCT06171191
NCT06171191招募中不适用

Move ARound And Get Active: an Intervention to Optimize 24-hour Movement Behaviours in Preschoolers

University Hospital, Ghent8 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年7月27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
200
试验地点
8
主要终点
24-hour movement behaviour: physical activity, sedentary behaviour and sleep

研究概览

简要总结

In 2019, the World Health Organization established new guidelines for physical activity, sedentary screen time, and sleep for children under 5 years old. Unfortunately, only a few (6%) of preschoolers in Flanders, Belgium, adhere to these guidelines. The aim of this study is to test a health program developed to optimize 24-hour behaviors in preschoolers and encourage more children to follow the guidelines. The program was created using the Intervention Mapping Protocol in collaboration with parents. It consists of seven sessions for parents and preschoolers, providing strategies to encourage compliance with the guidelines. The program's effectiveness will be evaluated through a randomized controlled trial, with the intervention group attending the sessions and the control group receiving the intervention materials at the end of the study.

详细描述

In 2019, the World Health Organization (WHO) established new guidelines for physical activity, sedentary screen behavior, and sleep in children under 5 years old (WHO, 2019). Unfortunately, only a few (6%) preschoolers in Flanders, Belgium, adhere to these guidelines (De Craemer et al., 2018). The objective of this study is to test a health program developed to optimize 24-hour behaviors in preschoolers and encourage more children to adhere to the guidelines. The program was developed using the Intervention Mapping Protocol, in collaboration with parents (Bartholomew, 2011). The program consists of seven sessions for parents and preschoolers, providing strategies to encourage adherence to the guidelines through parenting skills within the framework of self-determination theory (Di Pasquale et al., 2018). The program will be evaluated through a randomized controlled trial. The intervention group will attend the sessions, while the control group will receive the intervention materials at the end of the study.

Aims:

The primary aim is to analyze the intervention effect on 24-hour movement behaviors:

  1. Do more preschoolers comply with the World Health Organization 24-hour movement behavior guidelines?
  2. Is there an optimal change in the 24-hour composition of preschoolers (i.e., more physical activity, less screen time, and/or more sufficient sleep relative to each other)?

The secondary aims are: 3. To analyze the intervention effect on parenting within the self-determination theory: Do parents provide more structure, autonomy support, and positive involvement? 4. Process evaluation of the intervention: Describing fidelity, dose delivered, dose received, reach, and context based on Saunders et al. (2005).

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 (Participant)

入排标准

年龄范围
30 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Preschoolers between 2,5 to 6 years
  • One parent per preschooler
  • Parent needs to be able to understand, speak, read and write Dutch
  • Child needs to be able to understand Dutch
  • Child needs to be able to wear accelerometer
  • Child needs to by mentally and physically able to comply with the 24-hour movement behavior guidelines
  • Parent needs to be mentally able to complete the testing and intervention

排除标准

  • Are clear based on the inclusion criteria
  • Participants will be excluded form analyses when incomplete data required to answer the research question

研究组 & 干预措施

Intervention group

Experimental

Intervention group receives intervention between prétest and posttest. Three months after posttest they undergo a follow-up test

干预措施: Move-ARound And Get Active (Behavioral)

Control group

Other

Waiting group. Control group receives intervention after all test (prétest, posttest and follow-up test)

干预措施: Move-ARound And Get Active (Behavioral)

结局指标

主要结局

24-hour movement behaviour: physical activity, sedentary behaviour and sleep

时间窗: Results in October 2024

These behaviours will be assessed with accelerometers (GT3X+), To differentiate sedentary behavior from light physical activity and light physical activity from moderate to vigourous physical activity cut-points of 25 and 420 counts/15 seconds will be used respectively (Evenson et al., 2008; Pate et al., 2006)

次要结局

  • Process(Results in October 2024)
  • Parenting practices(Results in October 2024)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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