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

28. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

314

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Finland
      • Tampere, Finland
        • Tampere University
        • Kontakt:
        • Underforsker:
          • Jenny H Gustafsson, Doctoral researcher

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Waitlist control
Participants in the control group will continue with standard school practices.
Andet: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in raw scores for each subtest and the total raw score on the Test of Gross Motor Development Third Edition (TGMD-3)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in the perceived motor competence measured using the Pictorial Scale of Perceived Movement Skill Competence (PMSC)
Tidsramme: 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
Tidsramme: 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.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intervention adherence
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: At baseline assessments.
Child waist circumference will be measured objectively and recorded to the nearest 0.1 cm.
At baseline assessments.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tampere University

Samarbejdspartnere

UKK Institute
Juho Vainio Foundation

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

10. august 2026

Primær færdiggørelse (Anslået)

31. januar 2027

Studieafslutning (Anslået)

31. maj 2027

Datoer for studieregistrering

Først indsendt

22. juni 2026

Først indsendt, der opfyldte QC-kriterier

28. juni 2026

Først opslået (Faktiske)

1. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R25024

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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