App-based Motor Skills Intervention in Primary School and Home Settings

Официальное название

DigiKids C-RCT: App-based Motor Skills Intervention in Primary School and Home Settings

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое App-based Motor Skills Intervention
  The DigiKids intervention will be delivered over 12 weeks as part of the school curriculum using the Geego Kids application. Intervention includes two main components delivered via Geego Kids application: (1) Teacher interface. Two 3-minute structured movement breaks each school day and 18 weekly homework assignments including monitoring of completition. (2) User interface for children and guardians. Guardians are instructed to support homework assignments. The total activity time with the inter
• Другое Standard school practices
  Control schools will continue standard school practices as usual. After the 7-month follow-up, the waitlist control group will be offered one-year access to the application and will receive the intervention materials as described for the intervention group below. During this period, teachers in these schools may decide how to use the intervention materials and the application in their teaching practices.

Первичные конечные точки

• Change in raw scores for each subtest and the total raw score on the Test of Gross Motor Development Third Edition (TGMD-3) [Срок оценки: From baseline to week 12 and at the 7-month follow-up.]

Вторичные конечные точки (2)

• Change in the perceived motor competence measured using the Pictorial Scale of Perceived Movement Skill Competence (PMSC) [Срок оценки: From baseline to week 12 and at the 7-month follow-up.]
• Change in the device-assessed physical activity using the UKK RM42 accelerometer [Срок оценки: From baseline to week 12 and at the 7-month follow-up.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Финляндия · 1 центр

• Tampere University — Tampere

Публикации

• Rothbart MK, Ahadi SA, Hershey KL, Fisher P. Investigations of temperament at three to seven years: the Children's Behavior Questionnaire. Child Dev. 2001 Sep-Oct;72(5):1394-408. doi: 10.1111/1467-8624.00355. PMID 11699677
• Ulrich DA. Test of Gross Motor Development-Third Edition. Published online June 12, 2023. doi:10.1037/t87935-000
• Barnett LM, Ridgers ND, Zask A, Salmon J. Face validity and reliability of a pictorial instrument for assessing fundamental movement skill perceived competence in young children. J Sci Med Sport. 2015 Jan;18(1):98-102. doi: 10.1016/j.jsams.2013.12.004. Epub 2014 Jan 2. PMID 24485803

Идентификаторы

NCT: NCT07679633 · R25024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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