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HealthyDigiKids RCTNCT07679633

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

A study testing App-based Motor Skills Intervention and Standard school practices in people with Healthy and Motor Activity, run by Tampere University at 1 site in Finland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 8 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Motor Activity
What is being tested?
App-based Motor Skills Intervention and Standard school practices
Could I receive a placebo?
No, everyone receives an active treatment
How many people
314 participants
Where
1 siteFinland
Study dates
10 Aug 2026to 31 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Tampere University

    Tampere

Other trials in Finland

About this study

Official title: 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.

Read the detailed description

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.

Being tested
App-based Motor Skills Intervention, Standard school practices
Keywords
Physical Activity, Mobile Applications, Child, Behavior, Motor Skills
Medical subject headings
Motor Activity, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • App-based Motor Skills InterventionBehavioural

    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.

  • Standard school practicesOther

    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.

Study groups in NCT07679633
Study groupRoleWhat they receive
Waitlist controlOtherParticipants in the control group will continue with standard school practices.
Receives: Other: Standard school practices
DigiKids interventionExperimentalParticipants 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.
Receives: Behavioral: App-based Motor Skills Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

  1. Change in the perceived motor competence measured using the Pictorial Scale of Perceived Movement Skill Competence (PMSC)

    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.

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

  2. Change in the device-assessed physical activity using the UKK RM42 accelerometer

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2026
  2. Study start10 Aug 2026
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
314 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07679633
Sponsor's protocol ID
R25024
Acronym
DigiKids RCT
Status last verified
Sep 2026
First submitted
22 Jun 2026
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to ethical and data protection considerations in a target group representing a vulnerable population.

Publications

  • 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.

    PubMed 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.

    PubMed 24485803

Questions about this trial

What is this clinical trial studying?

A study testing App-based Motor Skills Intervention and Standard school practices in people with Healthy and Motor Activity, run by Tampere University at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in raw scores for each subtest and the total raw score on the Test of Gross Motor Development Third Edition (TGMD-3) (time frame: From baseline to week 12 and at the 7-month follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07679633, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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