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| Name | Class |
|---|---|
| Juho Vainio Foundation | OTHER |
| UKK Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Waitlist control | Other | Participants in the control group will continue with standard school practices. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App-based Motor Skills Intervention | Behavioral | 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. |
| 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) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Ă— 4), for ball skills 28 points (7 Ă— 4), and the maximum total score is 52 points. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention adherence | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenny Gustafsson | Contact | +358504358331 | jenny.gustafsson@tuni.fi | |
| Pilvikki Absetz, Professor | Contact | +358469215112 | pilvikki.absetz@tuni.fi |
| Name | Affiliation | Role |
|---|---|---|
| Pilvikki Absetz, Professor | Tampere University | Study Director |
| Jenny H Gustafsson, Doctoral researcher | Tampere University | Principal Investigator |
| Eero A Haapala, Docent |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere University | Tampere | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11699677 | Background | 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. | |
| Background | Ulrich DA. Test of Gross Motor Development-Third Edition. Published online June 12, 2023. doi:10.1037/t87935-000 | ||
| 24485803 |
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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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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D001519 | Behavior |
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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.
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Research assistants conducting the data collection will remain blinded to group allocation throughout the study.
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| Standard school practices | Other | 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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| 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. | From baseline to week 12 and at the 7-month follow-up. |
| From baseline to week 12 and at the 7-month follow-up. |
| Child temperament | 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 | 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 | 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 | 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 | Child height will be measured objectively without shoes and recorded to the nearest 0.1 cm. | At baseline assessments. |
| 10. Child waist circumference | Child waist circumference will be measured objectively and recorded to the nearest 0.1 cm. | At baseline assessments. |
| South-Eastern Finland University of Applied Sciences |
| Principal Investigator |
| Mari H Leppänen, Docent | UKK Institute | Principal Investigator |
| 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. |