- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07679633
App-based Motor Skills Intervention in Primary School and Home Settings (DigiKids RCT)
June 28, 2026 updated by: 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
314
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jenny Gustafsson
- Phone Number: +358504358331
- Email: jenny.gustafsson@tuni.fi
Study Contact Backup
- Name: Pilvikki Absetz, Professor
- Phone Number: +358469215112
- Email: pilvikki.absetz@tuni.fi
Study Locations
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-
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Tampere, Finland
- Tampere University
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Contact:
- Pilvikki S Absetz, Professor
- Phone Number: +358469215112
- Email: pilvikki.absetz@tuni.fi
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Sub-Investigator:
- Jenny H Gustafsson, Doctoral researcher
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Waitlist control
Participants in the control group will continue with standard school practices.
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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.
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Experimental: 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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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From baseline to week 12 and at the 7-month follow-up.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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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.
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From baseline to week 12 and at the 7-month follow-up.
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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.
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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.
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From baseline to week 12 and at the 7-month follow-up.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention adherence
Time Frame: 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.
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From baseline to week 12 and at the 7-month follow-up.
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Child temperament
Time Frame: At baseline assessments.
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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).
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At baseline assessments.
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Child motivational factors
Time Frame: At baseline, 12-week, and 7-month assessments.
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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.
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At baseline, 12-week, and 7-month assessments.
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Family factors
Time Frame: At baseline assessments. Selected questions at baseline, 12-week, and 7-month assessments.
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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).
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At baseline assessments. Selected questions at baseline, 12-week, and 7-month assessments.
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Child weight
Time Frame: At baseline assessments.
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Child body weight will be measured objectively in light indoor clothing and without shoes and recorded to the nearest 0.1 kg.
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At baseline assessments.
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9. Child height
Time Frame: At baseline assessments.
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Child height will be measured objectively without shoes and recorded to the nearest 0.1 cm.
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At baseline assessments.
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10. Child waist circumference
Time Frame: At baseline assessments.
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Child waist circumference will be measured objectively and recorded to the nearest 0.1 cm.
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At baseline assessments.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Pilvikki Absetz, Professor, Tampere University
- Principal Investigator: 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 10, 2026
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
May 31, 2027
Study Registration Dates
First Submitted
June 22, 2026
First Submitted That Met QC Criteria
June 28, 2026
First Posted (Actual)
July 1, 2026
Study Record Updates
Last Update Posted (Actual)
July 1, 2026
Last Update Submitted That Met QC Criteria
June 28, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R25024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be shared due to ethical and data protection considerations in a target group representing a vulnerable population.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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