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App-based Motor Skills Intervention in Primary School and Home Settings (DigiKids RCT)

28. června 2026 aktualizováno: Jenny Gustafsson, Tampere University

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

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

314

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Finsko
      • Tampere, Finsko
        • Tampere University
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Jenny H Gustafsson, Doctoral researcher

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ano

Popis

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Jiný: Waitlist control
Participants in the control group will continue with standard school practices.
Jiný: 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.
Experimentální: 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.
Behaviorální: 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 intervention during the school hours is approximately 6 minutes per day, corresponding to 30 minutes per week. At home, the estimated minimum activity time is approximately 45 minutes per week. A total estimated activity time of the intervention is 900 minutes (approximately 75 minutes per week over 12 weeks). In addition, teachers and children with guardians are permitted free use of the application.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in raw scores for each subtest and the total raw score on the Test of Gross Motor Development Third Edition (TGMD-3)
Časové okno: 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.
From baseline to week 12 and at the 7-month follow-up.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in the perceived motor competence measured using the Pictorial Scale of Perceived Movement Skill Competence (PMSC)
Časové okno: From baseline to week 12 and at the 7-month follow-up.
A validated instrument for children aged 4-8 years. The instrument includes pictorial items aligned with TGMD-3 fundamental movement skills. The maximum score for locomotor skills is 24 points (6 × 4), for ball skills 28 points (7 × 4), and the maximum total score is 52 points.
From baseline to week 12 and at the 7-month follow-up.
Change in the device-assessed physical activity using the UKK RM42 accelerometer
Časové okno: From baseline to week 12 and at the 7-month follow-up.
The UKK RM42 provides high-resolution data on movement intensity, frequency, and duration, enabling the assessment of total physical activity, time spent in different intensity zones (e.g., light, moderate, vigorous), and sedentary behavior. Accelerometer will be worn on the hip for seven consecutive days during waking hours.
From baseline to week 12 and at the 7-month follow-up.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Intervention adherence
Časové okno: From baseline to week 12 and at the 7-month follow-up.
User adherence in the app is automatically tracked via the Geego Kids application in both school and home settings. Objective data includes the number and type of movement breaks and physical activity homework videos completed, as well as frequency of use. Adherence to the intervention protocol will be evaluated based on the completion of movement breaks in school settings and homework tasks in home settings. An acceptable level of intervention completion is defined as completion of at least 80% of the intervention tasks in both settings.
From baseline to week 12 and at the 7-month follow-up.
Child temperament
Časové okno: At baseline assessments.
Child temperamental traits are assessed using the Very Short Form of the Children's Behavior Questionnaire (CBQ), a validated and widely used parent-report instrument designed for early to middle childhood. The CBQ measures multiple dimensions of temperament, originally adapted from constructs examined in both infants and adults. The parent-reported questionnaire includes 36 items, with a 7-point Likert scale (ranging from 1 = extremely false to 7 = extremely true).
At baseline assessments.
Child motivational factors
Časové okno: At baseline, 12-week, and 7-month assessments.
Child's motivational factors related to activities are assessed through a parent-reported questionnaire, developed specifically for the purposes of this study. Responses are in a 6-point scale (1 = significantly decreases my child's motivation; 2 = somewhat decreases my child's motivation; 3 = has little or no effect on my child's motivation; 4 = somewhat increases my child's motivation; 5 = significantly increases my child's motivation; 6 = I am unable to say). The questionnaire will consist of 30 items addressing factors describing children's motivation to participate in various physical activities or play.
At baseline, 12-week, and 7-month assessments.
Family factors
Časové okno: At baseline assessments. Selected questions at baseline, 12-week, and 7-month assessments.
Parent-reported background measures including family income and highest education, family dynamics (parental support, setting limits, communication, parental role modeling), family physical activity habits, digital device usage (the number of devices the child can use, daily sedentary and overall screen time, the level of parental control over the child's device use, and the use of digital devices in parenting practices).
At baseline assessments. Selected questions at baseline, 12-week, and 7-month assessments.
Child weight
Časové okno: At baseline assessments.
Child body weight will be measured objectively in light indoor clothing and without shoes and recorded to the nearest 0.1 kg.
At baseline assessments.
9. Child height
Časové okno: At baseline assessments.
Child height will be measured objectively without shoes and recorded to the nearest 0.1 cm.
At baseline assessments.
10. Child waist circumference
Časové okno: At baseline assessments.
Child waist circumference will be measured objectively and recorded to the nearest 0.1 cm.
At baseline assessments.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Tampere University

Spolupracovníci

UKK Institute
Juho Vainio Foundation

Vyšetřovatelé

  • Ředitel studie: Pilvikki Absetz, Professor, Tampere University
  • Vrchní vyšetřovatel: Jenny H Gustafsson, Doctoral researcher, Tampere University
  • Vrchní vyšetřovatel: Eero A Haapala, Docent, South-Eastern Finland University of Applied Sciences
  • Vrchní vyšetřovatel: Mari H Leppänen, Docent, UKK Institute

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

10. srpna 2026

Primární dokončení (Odhadovaný)

31. ledna 2027

Dokončení studie (Odhadovaný)

31. května 2027

Termíny zápisu do studia

První předloženo

22. června 2026

První předloženo, které splnilo kritéria kontroly kvality

28. června 2026

První zveřejněno (Aktuální)

1. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

1. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • R25024

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual participant data will not be shared due to ethical and data protection considerations in a target group representing a vulnerable population.

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