NCT07679633

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for not_applicable healthy

Timeline
10mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

August 10, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 22, 2026

Last Update Submit

June 28, 2026

Conditions

Keywords

Physical ActivityMobile ApplicationsChildBehaviorMotor Skills

Outcome Measures

Primary Outcomes (1)

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

    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.

Secondary Outcomes (2)

  • 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.

Other Outcomes (7)

  • Intervention adherence

    From baseline to week 12 and at the 7-month follow-up.

  • Child temperament

    At baseline assessments.

  • Child motivational factors

    At baseline, 12-week, and 7-month assessments.

  • +4 more other outcomes

Study Arms (2)

Waitlist control

OTHER

Participants in the control group will continue with standard school practices.

Other: Standard school practices

DigiKids intervention

EXPERIMENTAL

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.

Behavioral: App-based Motor Skills Intervention

Interventions

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.

DigiKids intervention

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.

Waitlist control

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University

Tampere, Finland

Location

Related Publications (3)

  • 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: 11699677BACKGROUND
  • Ulrich DA. Test of Gross Motor Development-Third Edition. Published online June 12, 2023. doi:10.1037/t87935-000

    BACKGROUND
  • 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: 24485803BACKGROUND

MeSH Terms

Conditions

Motor ActivityBehavior

Study Officials

  • Pilvikki Absetz, Professor

    Tampere University

    STUDY DIRECTOR
  • Jenny H Gustafsson, Doctoral researcher

    Tampere University

    PRINCIPAL INVESTIGATOR
  • Eero A Haapala, Docent

    South-Eastern Finland University of Applied Sciences

    PRINCIPAL INVESTIGATOR
  • Mari H Leppänen, Docent

    UKK Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pilvikki Absetz, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Research assistants conducting the data collection will remain blinded to group allocation throughout the study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: To evaluate the effectiveness of the DigiKids intervention, the study employs a cluster randomized controlled trial design, with schools serving as the unit of randomization and a 1:1 allocation ratio. Schools assigned to the intervention group receive a mobile app-based motor skills intervention during the study period and retain free access to the app until the 7-month follow-up. Schools assigned to the waitlist control group continue usual practices during the study period and receive the intervention materials and app access after the follow-up measurements.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2026

First Posted

July 1, 2026

Study Start (Estimated)

August 10, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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

Locations