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临床试验/NCT03659604
NCT03659604已完成不适用

A Clustered Randomized Controlled Trial to Compare the Effectiveness of and Engagement in a Mobile Exergame 'SmartLife' With Tailored Feedback

University Ghent2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2018年9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
240
试验地点
2
主要终点
Change in objectively measured physical activity (PA)

研究概览

简要总结

The aim of this study is to investigate the effectiveness of the 'SmartLife' intervention on reducing sedentary behavior and increasing physical activity among adolescents and to investigate the engagement in the exergame. This will be compared in three groups: an intervention group that will receive a tailored exergame; an active control condition that will receive a non-tailored exergame; and a passive control condition that receives no intervention.

详细描述

The aim of this study is to investigate the effectiveness of the 'SmartLife' intervention with tailored feedback on sedentary behavior and physical activity among adolescents and to investigate the engagement in the exergame. One intervention group will receive a version of the exergame that tailors feedback. This means tailored feedback will be based on data from a sensor which is integrated in a T-shirt and paired to the game. The active control group will receive a different version of the game, that does not provide tailored feedback.

Both groups will be compared to investigate their level of engagement in the game. A passive control group will be included that will be asked to continue their daily routines as usual. All three groups will be compared to determine the effectiveness of the 'SmartLife' intervention on physical activity and sedentary behavior.

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
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Between 12-18 years old
  • Access to an Android smartphone (4.0.1) during study period
  • No physical disabilities that hinder physical activity

排除标准

  • Not Dutch-speaking
  • Does not have access to an Android smartphone (4.0.1)

结局指标

主要结局

Change in objectively measured physical activity (PA)

时间窗: Baseline, 4 weeks, 8 weeks

Change in amount of total physical activity and moderate-to-vigorous physical activity, measured via accelerometers

次要结局

  • Change in determinants of PA(Baseline, 4 weeks, 8 weeks)
  • Change in determinants of SB(Baseline, 4 weeks, 8 weeks)
  • Change in behavior of PA(Baseline, 4 weeks, 8 weeks)
  • Differences in basic need satisfaction(4 weeks)
  • Change in subjectively measured Body Mass Index (BMI)(Baseline)
  • Change in objectively measured sedentary behavior (SB)(Baseline, 4 weeks, 8 weeks)
  • Differences in engagement(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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