Increasing Children's Physical Activity by Policy (CAP)

Not Applicable

• Conditions: Physical Activity; Sedentary Behavior
• Interventions: Other: Policy

• Registration Number: NCT04569578
• Lead Sponsor: Karolinska Institutet

Brief Summary

Levels of physical activity (PA) and physical fitness in children are low and declining, both globally and in Sweden. Preschools are important settings with the potential to influence the majority (\>93%) of Swedish children's PA behaviors in early stage of life (\<5 years). Preschool policy is an organizational level factor associated with children's PA but the casual link remains unclear. A cluster randomized controlled trial will be conducted to explore the feasibility and effectiveness of implementing a policy package for children's PA levels and other relevant health indicators.

Detailed Description

The overarching aim of the proposed project is to examine the effects of implementing physical activity (PA) policies in preschools on PA and indicators of health in young children. The proposed project is a unique collaboration between the applicants and Stockholm stad which will result in PA policies, that will be implemented in all 658 public preschools within the Stockholm region, having the possibility to affect more than 38 000 children.

The current study is designed as a cluster randomized controlled trial with 2 conditions (intervention vs. control) and preschools serving as the unit of randomization. Measures of primary and secondary outcomes will be obtained at baseline and at 6-months on an individual level.

This study will provide robust evidence of the effect of structural changes, at the organizational level of preschools, on children's PA and indicators of health. Notably, such robust evidence is urgently warranted as Swedish preschool children's PA levels are low which will have long-lasting effects on their lives. Finally, as the intervention has been developed in co-creation with Stockholm stad it has the possibility to, if proven effective, be implemented rapidly within preschools.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-16
• Study Start: 2020-09-23
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-30
• Primary Completion: 2021-07-02
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

On preschool level:

• Located in Stockholm county
• Public preschool
• At least 60 children enrolled in preschool
• Chief of the preschool accepted the invitation for participation

On individual level-preschool children

• Enrolled in participating preschool
• 3-5 years old at the time of study start
• Parents signed informed consent
• Can participate in regular physical activity

On individual level-preschool teachers

• Full-time employee at the participating preschool
• Teachers responsible for participating children

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Exclusion Criteria

On preschool level:

• Located outside Stockholm county
• Private preschool
• Less than 60 children enrolled in preschool
• Chief of the preschool not willing to participate

On individual level-preschool children

• Not enrolled in participating preschool
• Outside 3-5 years old age range at study start
• Parents declined informed consent
• Cannot participate in regular physical activity due to mobility disability etc.

On individual level-preschool teachers

• Not full-time employee at the participating preschool
• Not responsible for any participating children

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Policy	Policy	The policy will be implemented on preschool level.

Primary Outcome Measures

Name	Time	Method
Change in physical activity levels of children	Change from baseline 6 months follow-up in physical activity levels (daily minutes in moderate to vigorous physical activity)	Physical activity levels in terms of daily minutes in moderate to vigorous physical activity, total physical activity and daily steps measured objectively by Actigraph GT3X+ accelerometers

Secondary Outcome Measures

Name	Time	Method
Change in psychosocial functioning of children	Change from baseline to 6 months follow-up in psychosocial functioning	Psychosocial functioning of children will be assessed by a parental proxy report of the Strength and Difficulty Questionnaire. Total difficulties score is generated by summing scores from all the scales except the prosocial scale and ranges from 0 to 40, higher score means worse outcome.
Change in sleep of children	Change from baseline to 6 months follow-up in sleep	Sleep will be measured objectively by the GT3X+ accelerometer combined with a sleep time diary documented by parents during the days when the child is wearing the accelerometer. In addition, parents will answer questions about children's sleep duration and quality in the last 6 months in the sleep questionnaire. These sleep questions are adapted from the validated Ages and Stages Questionnaire. The sleep quality score ranges from 0-12 and higher score means better outcome.
Sick leave frequency of children	From 12 months prior the intervention starts and during the 6 months intervention period	Sick leave frequency in terms of total occasions of leave will be collected from the Stockholm City smartphone application "Anmäl frånvaro".
Change in anthropometry (waist circumference in cm) of teachers	Change from baseline to 6 months follow-up in anthropometry	Waist circumference will be measured at the level of the navel directly on the skin
Change in anthropometry (BMI) of teachers	Change from baseline to 6 months follow-up in anthropometry	Weight and height will be combined to report BMI in kg/m\^2
Sick leave duration of teachers	From 12 months prior the intervention starts and during the 6 months intervention period	Sick leave duration in terms of total days of leave will be collected from the Stockholm City smartphone application "Anmäl frånvaro".
Change in sedentary time of children	Change from baseline to 6 months follow-up in daily minutes in sedentary time	Daily sedentary time in minutes assessed by the Actigraph GT3X+
Change in anthropometry (weight in kg) of children	Change from baseline to 6 months follow-up in anthropometry	Weight will be measured by validated scales (calibrated scale: VB2-200-EC, Vetek AB, Väddö, Sweden)
Change in anthropometry (height in cm) of children	Change from baseline to 6 months follow-up in anthropometry	Height will be measured by validated scales (portable stadiometer: Seca 213, Seca, Chino, CA, USA)
Change in compliance with the World Health Organization (WHO) guidelines on physical activity, sedentary behaviour and sleep for children under 5 years of age	Change from baseline to 6 months follow-up in compliance with The WHO guidelines.	World Health Organization (WHO) has published guidelines recommending more than 180 minutes of total physical activity with at least 60 minutes of moderate to vigorous physical activity, less than one hour of screen time and 10-13 hours of sleep across 24 hours
Change in physical activity levels of teachers	Change from baseline to 6 months follow-up in physical activity levels	Physical activity levels in terms of daily minutes in moderate to vigorous physical activity measured by Actigraph GT3X+
Change in musculoskeletal fitness of teachers	Change from baseline to 6 months follow-up in musculoskeletal fitness (handgrip strength)	Musculoskeletal fitness, in terms of handgrip strength ,will be measured by an analogue dynamometer (TKK 5825, Grip-A, Takei, Tokyo, Japan).
Change in anthropometry (BMI) of children	Change from baseline to 6 months follow-up in anthropometry	Weight and height will be combined to report BMI in kg/m\^2
Sick leave duration of children	From 12 months prior the intervention starts and during the 6 months intervention period	Sick leave duration in terms of total days of leave will be collected from the Stockholm City smartphone application "Anmäl frånvaro".
Change in steps of teachers	Change from baseline to 6 months follow-up in steps	Steps measured by Actigraph GT3X+
Change in sedentary time of teachers	Change from baseline to 6 months follow-up in daily minutes in sedentary time	Daily sedentary time in minutes assessed by the Actigraph GT3X+
Change in anthropometry (weight in kg) of teachers	Change from baseline to 6 months follow-up in anthropometry	Weight validated scales (calibrated scale: VB2-200-EC, Vetek AB, Väddö, Sweden)
Change in anthropometry (height in cm) of teachers	Change from baseline to 6 months follow-up in anthropometry	Height will be measured by validated scales (portable stadiometer: Seca 213, Seca, Chino, CA, USA)
Change in musculoskeletal fitness of children	Change from baseline to 6 months follow-up in musculoskeletal fitness (handgrip strength)	Musculoskeletal fitness, in terms of handgrip strength ,will be measured by an analogue dynamometer (TKK 5825, Grip-A, Takei, Tokyo, Japan).
Change in anthropometry (waist circumference in cm) of children	Change from baseline to 6 months follow-up in anthropometry	Waist circumference will be measured at the level of the navel directly on the skin
Sick leave frequency of teachers	From 12 months prior the intervention starts and during the 6 months intervention period	Sick leave frequency in terms of total occasions of leave will be collected from the Stockholm City smartphone application "Anmäl frånvaro".

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden