跳至主要内容
临床试验/NCT05741879
NCT05741879已完成不适用

Gamified Exercise Intervention to Improve Children's Adherence to 24-hour Movement Recommendations in a Family-Based Health Setting: "3,2,1 Move on Crossover Study".

Universidad Pública de Navarra2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Changes in 24-h movement behaviors (accelerometers) sedentary time.

研究概览

简要总结

Physical inactivity is the fourth most important risk factor for mortality worldwide and it contributes to weight gain and obesity. On the contrary, it is established that regular physical activity is a prevention and managerial factor of these non-communicable diseases. Therefore, the goal of this study is to design and evaluate the effectiveness of a 12-week physical exercise and lifestyle improvement training program carried out in a family environment, through a web platform, and with "online" supervision. This platform will improve the physical conditioning and adherence to PE in a "family environment", and to promote good development of the child through physical activities and exercises that can be done as a family at home and/or outside.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Participants without any physical or mental disorders that would prevent them from completing the assessments tests or participating in the exercise intervention program
  • One parent/guardian must answer the questionnaires
  • Informed consent from the participants parent(s)/guardian(s)

排除标准

  • Participants with psychiatric disorders or chronic illness that limits their participation in physical activities
  • Participants who do not comply with the established procedures
  • Participants who do not understand the Spanish language

结局指标

主要结局

Changes in 24-h movement behaviors (accelerometers) sedentary time.

时间窗: Baseline, 12 Week, and 24 Week

During their visit to Navarrabiomed, participants will receive a (GENEActiv, Activinsights, Kimbolton, UK) accelerometer that will objectively measure their 24-hour movement behaviors (physical activity, sedentary behaviors, and sleep). The participants will wear the accelerometer for seven consecutive days. Additionally, this accelerometer data will be supplemented with a diary to validate sleep time and (non)wear time.

次要结局

  • Changes in executive function.(Baseline, 12 Week, and 24 Week)
  • Changes in health-related physical fitness.(Baseline, 12 Week, and 24 Week)
  • Changes in quality of life.(Baseline, 12 Week, and 24 Week)
  • Changes in body composition.(Baseline, 12 Week, and 24 Week)
  • Changes in Basic Motor Skills.(Baseline, 12 Week, and 24 Week)
  • Changes in muscle composition.(Baseline, 12 Week, and 24 Week)
  • Changes in 24-h movement behaviors (self-reported).(Baseline, 12 Week, and 24 Week)
  • Changes in Child Self-Regulation & Behavior.(Baseline, 12 Week, and 24 Week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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