Increasing Children's Physical Activity by Policy (CAP)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Increasing Children's Physical Activity by Policy (CAP): a Cluster Randomized Controlled Trial in the Stockholm Region Preschools

Conditions
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Physical Activity, Sedentary Behavior

Intervention / Treatment
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* Other: Policy


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Policy<br>The policy will be implemented on preschool level. | Other: Policy<br>* The intervention will include: i. Formalized physical activity policies implemented in preschools including the following: A minimum of 3 hours of total daily outdoor time scheduled both in the morning and in the afternoon At least 10 minutes teacher-led active play per day A minimum of 1 weekly outdoor excursion Meet the children outdoors when they arrive at preschool and/or picked up by their parents Only use screen tablets and computers for educational teaching purposes Communicating to, and encouraging, the parents to actively transport their children to and from preschools ii. A study website with an activity bank also serving as a platform for inter-professional education that preschool teachers can share and communicate about engaging activities and experience iii. Weekly follow-up and feedback by web-based questionnaires<br>|
| No Intervention: Regular practice<br>The control preschool will continue their regular practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity levels of children | 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 | Change from baseline 6 months follow-up in physical activity levels (daily minutes in moderate to vigorous physical activity) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sedentary time of children | Daily sedentary time in minutes assessed by the Actigraph GT3X+ | Change from baseline to 6 months follow-up in daily minutes in sedentary time | 
| Change in musculoskeletal fitness of children | Musculoskeletal fitness, in terms of handgrip strength ,will be measured by an analogue dynamometer (TKK 5825, Grip-A, Takei, Tokyo, Japan). | Change from baseline to 6 months follow-up in musculoskeletal fitness (handgrip strength) | 
| Change in anthropometry (weight in kg) of children | Weight will be measured by validated scales (calibrated scale: VB2-200-EC, Vetek AB, Väddö, Sweden) | Change from baseline to 6 months follow-up in anthropometry | 
| Change in anthropometry (height in cm) of children | Height will be measured by validated scales (portable stadiometer: Seca 213, Seca, Chino, CA, USA) | Change from baseline to 6 months follow-up in anthropometry | 
| Change in anthropometry (waist circumference in cm) of children | Waist circumference will be measured at the level of the navel directly on the skin | Change from baseline to 6 months follow-up in anthropometry | 
| Change in anthropometry (BMI) of children | Weight and height will be combined to report BMI in kg/m^2 | Change from baseline to 6 months follow-up in anthropometry | 
| Change in psychosocial functioning of children | 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 from baseline to 6 months follow-up in psychosocial functioning | 
| Change in sleep of children | 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. | Change from baseline to 6 months follow-up in sleep | 
| Sick leave duration of children | Sick leave duration in terms of total days of leave will be collected from the Stockholm City smartphone application Anmäl frånvaro. | From 12 months prior the intervention starts and during the 6 months intervention period | 
| Sick leave frequency of children | Sick leave frequency in terms of total occasions of leave will be collected from the Stockholm City smartphone application Anmäl frånvaro. | From 12 months prior the intervention starts and during the 6 months intervention period | 
| Change in compliance with the World Health Organization (WHO) guidelines on physical activity, sedentary behaviour and sleep for children under 5 years of age | 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 from baseline to 6 months follow-up in compliance with The WHO guidelines. | 
| Change in physical activity levels of teachers | Physical activity levels in terms of daily minutes in moderate to vigorous physical activity measured by Actigraph GT3X+ | Change from baseline to 6 months follow-up in physical activity levels | 
| Change in steps of teachers | Steps measured by Actigraph GT3X+ | Change from baseline to 6 months follow-up in steps | 
| Change in sedentary time of teachers | Daily sedentary time in minutes assessed by the Actigraph GT3X+ | Change from baseline to 6 months follow-up in daily minutes in sedentary time | 
| Change in musculoskeletal fitness of teachers | Musculoskeletal fitness, in terms of handgrip strength ,will be measured by an analogue dynamometer (TKK 5825, Grip-A, Takei, Tokyo, Japan). | Change from baseline to 6 months follow-up in musculoskeletal fitness (handgrip strength) | 
| Change in anthropometry (weight in kg) of teachers | Weight validated scales (calibrated scale: VB2-200-EC, Vetek AB, Väddö, Sweden) | Change from baseline to 6 months follow-up in anthropometry | 
| Change in anthropometry (height in cm) of teachers | Height will be measured by validated scales (portable stadiometer: Seca 213, Seca, Chino, CA, USA) | Change from baseline to 6 months follow-up in anthropometry | 
| Change in anthropometry (waist circumference in cm) of teachers | Waist circumference will be measured at the level of the navel directly on the skin | Change from baseline to 6 months follow-up in anthropometry | 
| Change in anthropometry (BMI) of teachers | Weight and height will be combined to report BMI in kg/m^2 | Change from baseline to 6 months follow-up in anthropometry | 
| Sick leave duration of teachers | Sick leave duration in terms of total days of leave will be collected from the Stockholm City smartphone application Anmäl frånvaro. | From 12 months prior the intervention starts and during the 6 months intervention period | 
| Sick leave frequency of teachers | Sick leave frequency in terms of total occasions of leave will be collected from the Stockholm City smartphone application Anmäl frånvaro. | From 12 months prior the intervention starts and during the 6 months intervention period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, preschool, randomized, intervention, sleep, sedentary behavior, sick leave