Tampere University
Tampere, Finland
Location contact
Jenny H Gustafsson, Doctoral researcher
SUB_INVESTIGATOR
Pilvikki S Absetz, Professor
CONTACT
NCT Number: NCT07679633
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.
Trial opening soon.
Get Notified6 year–8 year
All sexes
Interventional
Not applicable
Tampere, Finland
Jenny H Gustafsson, Doctoral researcher
SUB_INVESTIGATOR
Pilvikki S Absetz, Professor
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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).
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.
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).
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.
Time frame: At baseline assessments.
Child height will be measured objectively without shoes and recorded to the nearest 0.1 cm.
Time frame: At baseline assessments.
Child waist circumference will be measured objectively and recorded to the nearest 0.1 cm.
Contact information is provided by the study sponsor or research team.
Jenny Gustafsson
CONTACT
Pilvikki Absetz, Professor
CONTACT
Tampere University
Other
DigiKids C-RCT: App-based Motor Skills Intervention in Primary School and Home Settings
Acronym: DigiKids RCT
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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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