DigiKids C-RCT: App-based Motor Skills Intervention in Primary School and Home Settings
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 314
- 试验地点
- 1
- 主要终点
- Change in raw scores for each subtest and the total raw score on the Test of Gross Motor Development Third Edition (TGMD-3)
研究概览
简要总结
The objective of this trial is to evaluate the effectiveness of a mobile app-based motor skills intervention (DigiKids RCT) on motor competence, physical activity, and perceived motor competence compared with standard school practices in primary school children. In addition, the study will examine other factors such as child-specific and family-related factors that might influence the findings.
详细描述
This study will be conducted between August 2026 and January 2027 in Tampere, Finland. The target sample size will be 314 children enrolled from 22 classrooms across 18 primary schools, along with one caregiver from each participating family. In a cluster randomized controlled trial design, nine of the 27 primary schools are randomly allocated to an intervention group and nine to a control group. Randomization has been conducted prior to study initiation in the fall of 2025. The intervention group will receive a 12-week mobile app-based intervention which will be delivered in classrooms by teachers with homework tasks supported by guardians. A total estimated activity time of the intervention is 900 minutes (approximately 75 minutes per week over 12 weeks). The control group will continue the standard school practices. Data will be collected at baseline (T0), post-intervention (T1, 3 months post-baseline), and follow-up (T2, 7 months post-baseline). The primary outcome is motor competence, and the secondary outcomes include physical activity and perceived motor competence. The first results are anticipated to be available and published between 2027 and 2028.
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 (Outcomes Assessor)
盲法说明
Research assistants conducting the data collection will remain blinded to group allocation throughout the study.
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children enrolled in the first grade of primary school
- •Sufficient Finnish language proficiency
- •Written informed consent from the guardian and written assent from the child
排除标准
- •Age under 6 or over 8 years
- •Medical or physical conditions preventing participation in the assessments (including severe musculoskeletal complaints or concussions within the preceding 3 months)
- •Refusal to participate in baseline assessments
研究组 & 干预措施
Waitlist control
Participants in the control group will continue with standard school practices.
干预措施: Standard school practices (Other)
DigiKids intervention
Participants in the intervention group will receive a 12-week motor skills intervention, followed by free access to the application until the 7-month follow-up. The intervention will be integrated into daily classroom routines as part of the school curriculum and delivered through a teacher-supported digital application.
干预措施: App-based Motor Skills Intervention (Behavioral)
结局指标
主要结局
Change in raw scores for each subtest and the total raw score on the Test of Gross Motor Development Third Edition (TGMD-3)
时间窗: From baseline to week 12 and at the 7-month follow-up.
A validated and widely used assessment tool for evaluating fundamental movement skills in children aged 3-10 years. Maximum scores for locomotor skills are 46, ball skills 54, and total gross motor skills 100. In addition, the gross motor index (GMI) scores will be reported.
次要结局
- Change in the perceived motor competence measured using the Pictorial Scale of Perceived Movement Skill Competence (PMSC)(From baseline to week 12 and at the 7-month follow-up.)
- Change in the device-assessed physical activity using the UKK RM42 accelerometer(From baseline to week 12 and at the 7-month follow-up.)
研究者
Jenny Gustafsson
Principal Investigator
Tampere University