Increasing Children's Physical Activity by Policy (CAP)

Karolinska Institutet4,000 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

4,000

Conditions

Physical Activity Sedentary Behavior

Interventions

PolicyOTHER

The intervention will include: i. Formalized physical activity policies implemented in preschools including the following: 1. A minimum of 3 hours of total daily outdoor time scheduled both in the morning and in the afternoon 2. At least 10 minutes teacher-led active play per day 3. A minimum of 1 weekly outdoor excursion 4. Meet the children outdoors when they arrive at preschool and/or picked up by their parents 5. Only use screen tablets and computers for educational teaching purposes 6. 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

Eligibility

Sex: ALLMin age: 3 YearsMax age: 5 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Karolinska Institutet

Stockholm, Sweden

Outcomes

Primary Outcomes

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

Time frame: Change from baseline 6 months follow-up in physical activity levels (daily minutes in moderate to vigorous physical activity)

Secondary Outcomes

Change in sedentary time of children

Daily sedentary time in minutes assessed by the Actigraph GT3X+

Time frame: 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).

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: Change from baseline to 6 months follow-up in anthropometry

Data from ClinicalTrials.gov

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Change in anthropometry (BMI) of children

Weight and height will be combined to report BMI in kg/m\^2

Time frame: 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.

Time frame: 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.

Time frame: 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".

Time frame: 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".

Time frame: 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

Time frame: 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+

Time frame: Change from baseline to 6 months follow-up in physical activity levels

Change in steps of teachers

Steps measured by Actigraph GT3X+

Time frame: 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+

Time frame: 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).

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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".

Time frame: 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".

Time frame: From 12 months prior the intervention starts and during the 6 months intervention period