Clinical trial NCT04569578: Increasing Children's Physical Activity by Policy (CAP)
Official title: Increasing Children's Physical Activity by Policy (CAP): a Cluster Randomized Controlled Trial in the Stockholm Region Preschools
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Activity
Sedentary Behavior
Keywords: physical activity
preschool
randomized
intervention
sleep
sedentary behavior
sick leave
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Stockholm County Council (Center of Epidemiology and Community Medicine)
First posted: 2020-09-30
Enrollment: 4000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in physical activity levels of children
timeFrame: Change from baseline 6 months follow-up in physical activity levels (daily minutes in moderate to vigorous physical activity)
Secondary outcomes:
measure: Change in sedentary time of children
timeFrame: Change from baseline to 6 months follow-up in daily minutes in sedentary time
measure: Change in musculoskeletal fitness of children
timeFrame: Change from baseline to 6 months follow-up in musculoskeletal fitness (handgrip strength)
measure: Change in anthropometry (weight in kg) of children
timeFrame: Change from baseline to 6 months follow-up in anthropometry
measure: Change in anthropometry (height in cm) of children
timeFrame: Change from baseline to 6 months follow-up in anthropometry
measure: Change in anthropometry (waist circumference in cm) of children
timeFrame: Change from baseline to 6 months follow-up in anthropometry
measure: Change in anthropometry (BMI) of children
timeFrame: Change from baseline to 6 months follow-up in anthropometry
measure: Change in psychosocial functioning of children
timeFrame: Change from baseline to 6 months follow-up in psychosocial functioning
measure: Change in sleep of children
timeFrame: Change from baseline to 6 months follow-up in sleep
measure: Sick leave duration of children
timeFrame: From 12 months prior the intervention starts and during the 6 months intervention period
measure: Sick leave frequency of children
timeFrame: From 12 months prior the intervention starts and during the 6 months intervention period
measure: Change in compliance with the World Health Organization (WHO) guidelines on physical activity, sedentary behaviour and sleep for children under 5 years of age
timeFrame: Change from baseline to 6 months follow-up in compliance with The WHO guidelines.
measure: Change in physical activity levels of teachers
timeFrame: Change from baseline to 6 months follow-up in physical activity levels
measure: Change in steps of teachers
timeFrame: Change from baseline to 6 months follow-up in steps
measure: Change in sedentary time of teachers
timeFrame: Change from baseline to 6 months follow-up in daily minutes in sedentary time
measure: Change in musculoskeletal fitness of teachers
timeFrame: Change from baseline to 6 months follow-up in musculoskeletal fitness (handgrip strength)
measure: Change in anthropometry (weight in kg) of teachers
timeFrame: Change from baseline to 6 months follow-up in anthropometry
measure: Change in anthropometry (height in cm) of teachers
timeFrame: Change from baseline to 6 months follow-up in anthropometry
measure: Change in anthropometry (waist circumference in cm) of teachers
timeFrame: Change from baseline to 6 months follow-up in anthropometry
measure: Change in anthropometry (BMI) of teachers
timeFrame: Change from baseline to 6 months follow-up in anthropometry
measure: Sick leave duration of teachers
timeFrame: From 12 months prior the intervention starts and during the 6 months intervention period
measure: Sick leave frequency of teachers
timeFrame: From 12 months prior the intervention starts and during the 6 months intervention period
Other outcomes:
measure: Change in preschool policy and environmental characteristics (process outcome)
timeFrame: Change from baseline preschool policy and environmental characteristics at 3 months and at 6 months
measure: Implementation of the policy package (process outcome)
timeFrame: Measured weekly throughout 6 months only in intervention preschools
measure: Normalization of the policy package into preschool teachers' regular practice (process outcome)
timeFrame: Measured at 6 months only in intervention preschools
measure: Change in children's physical activity opportunities outside preschool time (process outcome)
timeFrame: Change from baseline to 6 months follow-up in children's physical activity opportunities outside preschool time
measure: Project evaluation from parents
timeFrame: Measured at 6 months (questionnaires and interviews)
measure: Project evaluation from preschool teachers
timeFrame: Measured at 6 months ((questionnaires and interviews)
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Daniel Berglind, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen C, Ahlqvist VH, Henriksson P, Migueles JH, Christiansen F, Galanti MR, Berglind D. Increasing Children's physical Activity by Policy (CAP) in preschools within the Stockholm region: study protocol for a pragmatic cluster-randomized controlled trial. Trials. 2022 Jul 19;23(1):577. doi: 10.1186/s13063-022-06513-4.