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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Healthy, Motor Activity
- 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 group | Role | What they receive |
|---|---|---|
| Waitlist control | Other | Participants in the control group will continue with standard school practices. Receives: 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. Receives: Behavioral: App-based Motor Skills Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
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.
- First posted1 Jul 2026
- Study start10 Aug 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- Juho Vainio Foundation, UKK Institute
- Responsible party
- Principal investigator, Jenny Gustafsson, Tampere University
- Investigators
- Pilvikki Absetz, Professor, Study director, Tampere UniversityJenny H Gustafsson, Doctoral researcher, Principal investigator, Tampere UniversityEero A Haapala, Docent, Principal investigator, South-Eastern Finland University of Applied SciencesMari H Leppänen, Docent, Principal investigator, UKK Institute
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 11699677Ulrich 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DigiKids C-RCT: App-based Motor Skills Intervention in Primary School and Home Settings
- ClinicalTrials.gov ID
- NCT07679633
- Acronym / sponsor ID
- DigiKids RCT / R25024
- Conditions
- Healthy, Motor Activity
- Keywords
- Physical Activity, Mobile Applications, Child, Behavior, Motor Skills
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- Juho Vainio Foundation, UKK Institute
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Waitlist control | Other | Other: Standard school practicesParticipants in the control group will continue with standard school practices. |
| DigiKids intervention | Experimental | Behavioral: App-based Motor Skills InterventionParticipants 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. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-based Motor Skills InterventionThe 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. | Behavioural | DigiKids intervention |
| Standard school practicesControl 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. | Other | Waitlist control |
Primary outcome
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.
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.
2 secondary outcomes
Change in the perceived motor competence measured using the Pictorial Scale of Perceived Movement Skill Competence (PMSC)
Time frame: From baseline to week 12 and at the 7-month follow-up.
Change in the device-assessed physical activity using the UKK RM42 accelerometer
Time frame: From baseline to week 12 and at the 7-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 11699677Rothbart 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.
- BackgroundUlrich DA. Test of Gross Motor Development-Third Edition. Published online June 12, 2023. doi:10.1037/t87935-000
- Background: PubMed 24485803Barnett 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pilvikki Absetz, Professor study director
Tampere University
Jenny H Gustafsson, Doctoral researcher principal investigator
Tampere University
Eero A Haapala, Docent principal investigator
South-Eastern Finland University of Applied Sciences
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 6 Nov 2026.