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临床试验/NCT05480085
NCT05480085已完成不适用

Screen Free Time With Friends Feasibility Trial

University of Southern Denmark3 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2022年8月19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
204
试验地点
3
主要终点
Feasibility of the intervention

研究概览

简要总结

The Screen Free Time with Friends Feasibility Trial is a study designed to inform development of a definitive trial. The feasibility trial aims to 1) examine the feasibility of an intervention aimed to limit recreational screen media use and promote more time with peers after school and during weekends among 10-11 year old children, 2) examine participant recruitment and retention rates, 3) examine the feasibility of the data collection plan and completeness of the compliance and outcome assessment, and 4) obtain baseline and follow-up data on the planned full trial primary outcome. The Screen Free Time with Friends Feasibility Trial will be conducted as a non-randomized single group feasibility trial including children, their parents and school and afterschool personal from 3rd grade school classes from different schools in the Region of Southern Denmark. The goal is to include a representative sample of children and parents in the participating 3rd grades, and thus there will be no individual level inclusion and exclusion criteria. A process evaluation and outcome measurements will be conducted to evaluate the feasibility and acceptability of the intervention, the data collection plan, and compliance. A baseline- and follow-up assessment will be carried out for some measurements, while others will be collected continuously during the intervention period.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
8 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • the distance between the school and the related afterschool club is in walking and cycling distance
  • the afterschool club must have potential for improvement (assessed by the municipality)
  • the afterschool club personal must have a wish to develop the afterschool club

排除标准

  • 未提供

结局指标

主要结局

Feasibility of the intervention

时间窗: After completion of different intervention components

The feasibility of the intervention is evaluated using process evaluation inspired by the RE-AIM framework. Questionnaires and interviews with parents, local workshop participants, school and afterschool club personal, municipality and research team focusing on the recruitment process, intervention and measurements will be used to assess acceptability.

次要结局

  • Participant recruitment and retention rate(Baseline and 6-month follow-up)
  • Compliance to a parent questionnaire(Baseline and 6-month follow-up)
  • Compliance to leisure time activities measurement(Three times/week for three weeks at baseline and 6-month follow-up)
  • Compliance to wellbeing measurement(Baseline and 6-month follow-up)
  • Compliance to a child questionnaire(Baseline and 6-month follow-up)
  • Compliance to objective physical activity measurement(Baseline and 6-month follow-up)
  • Compliance to objective screen media use measurement(Baseline and 6-month follow-up)
  • Compliance to subjective screen media use measurement(Three times/week for three weeks at baseline and 6-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anders Groentved

Professor

University of Southern Denmark

研究点 (3)

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