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NCT Number: NCT07679633

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.

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Key information

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University

Tampere, Finland

Location contact

Jenny H Gustafsson, Doctoral researcher

SUB_INVESTIGATOR

Pilvikki S Absetz, Professor

CONTACT

[email protected]

+358469215112

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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)

    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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

Other outcomes

  1. 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.

  2. Child temperament

    Time frame: At baseline assessments.

    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).

  3. Child motivational factors

    Time frame: At baseline, 12-week, and 7-month assessments.

    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.

  4. Family factors

    Time frame: At baseline assessments. Selected questions at baseline, 12-week, and 7-month assessments.

    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).

  5. Child weight

    Time frame: At baseline assessments.

    Child body weight will be measured objectively in light indoor clothing and without shoes and recorded to the nearest 0.1 kg.

  6. 9. Child height

    Time frame: At baseline assessments.

    Child height will be measured objectively without shoes and recorded to the nearest 0.1 cm.

  7. 10. Child waist circumference

    Time frame: At baseline assessments.

    Child waist circumference will be measured objectively and recorded to the nearest 0.1 cm.

Study contacts

Contact information is provided by the study sponsor or research team.

Jenny Gustafsson

CONTACT

[email protected]

+358504358331

Pilvikki Absetz, Professor

CONTACT

[email protected]

+358469215112

Sponsors and collaborators

Lead sponsor

Tampere University

Other

Collaborators

  • Juho Vainio Foundation
  • UKK Institute

Registry information

Official study title

DigiKids C-RCT: App-based Motor Skills Intervention in Primary School and Home Settings

Acronym: DigiKids RCT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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