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临床试验/NCT04540523
NCT04540523撤回不适用

Effects of Home-based Exergaming on Preschoolers' Physical Activity and Cognition

University of Minnesota2 个研究点 分布在 1 个国家开始时间: 2020年9月8日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Change in physical activity levels

研究概览

简要总结

This study will employ a 3-arm randomized clinical trial to determine the effects of a 6-month home-based exergaming intervention on preschoolers' physical activity, health-related fitness, cognition, and screen time, across time, at 3, 6 and 12 months, and as an exploratory outcome, will explore the moderating effects of parent involvement and physical home environment on the intervention role of exergaming across time. Briefly, a total of 330 child-parent dyads from the Twin Cities area in Minnesota will be individually randomly assigned to: 1) an exergaming intervention group (30 min. per session, 5 sessions exergaming play per week for a 6-month period); 2) a traditional PA group (phone consultations and workshops for parents to offer 5 times 30 min. PA at home for 6 months); and 3) an attention control group (continue with usual activities at home with emailed PA tips).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Investigator)

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

  • response to an advertisement for the study;
  • has only one child aged 4-5 years old in the family;
  • speaks English;
  • family with income within 185% of the Federal Poverty Guideline Levels determined by parents' self-report;
  • has a TV with HDMI port or VGA port or video port at home
  • the child has no medical conditions or physical disabilities that prohibit engagement in PA;
  • physically inactive child who does not meet 120 min. PA per day;
  • parental agreement to participating in the home visits and evaluations;
  • lives within 20 miles of the UMN;
  • family willingness to commit to 6 months of intervention and 6 months of follow-up;
  • not moving out of area for the next 12 months.

排除标准

  • children/parents from families that already own exergame(s) as these children tend to possess high experience levels with exergaming play;
  • child who are physically active for more than recommended 180 min. PA per day as reported by parents.

结局指标

主要结局

Change in physical activity levels

时间窗: 0, 3, 12 months (follow-up)

Preschoolers' 5-day daily PA levels will be assessed using ActiGraph Link GT9X accelerometers (Pensacola, FL) at each testing cycle. The Link is lightweight and resembles a watch, and is a valid and reliable measure of PA among young children in free-living settings. Children will be instructed to wear the accelerometers on the non-dominant wrist at all times with the exception of time spent swimming for 3 weekday and 2 weekend days. In this project, activity counts will be set at 1-second epochs. Counts will be interpreted using empirically based cut points that define different PA intensities for preschoolers. Children's daily average minutes engaged in PA (MVPA and light PA) and sedentary behavior will be used as the outcome variables. Acceptable inclusion criteria for PA data will be recording of an average of 10 hours of accelerometer data per day. Compliance with wearing monitors will be facilitated according to Trost recommendations.

次要结局

  • Change in percent body fat(0, 3, 12 months (follow-up))
  • Change in cognition(0, 3, 12 months (follow-up))
  • Change in bodyweight(0, 3, 12 months (follow-up))
  • Change in body mass index (BMI)(0, 3, 12 months (follow-up))
  • Change in health-related fitness(0, 3, 12 months (follow-up))
  • Change in screen time(0, 3, 12 months (follow-up))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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