Increasing Children's Physical Activity by Policy (CAP)

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04569578
• Other study ID #: CAP2020
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 23, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2021
• Est. primary completion date: July 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity
• Sedentary Behavior

Intervention

Other:
• Policy
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

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council (Center of Epidemiology and Community Medicine)

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in preschool policy and environmental characteristics (process outcome)	Preschool environmental characteristic such as available paly equipment, playground characteristic, policy, working practices will be assessed by validated Environment and Policy Evaluation and Observation as a Self-Report Instrument (EPAO-SR). The preschool playground characteristics and size will be double checked using google maps.	Change from baseline preschool policy and environmental characteristics at 3 months and at 6 months
Other	Implementation of the policy package (process outcome)	Fidelity and dose of the implementation of the policy package will be documented through weekly feedback questionnaires throughout the intervention.	Measured weekly throughout 6 months only in intervention preschools
Other	Normalization of the policy package into preschool teachers' regular practice (process outcome)	The extent to which the intervention can be normalized into preschool staff's regular practice will be assessed through No-MAD: Implementation measure based on Normalization Process Theory.	Measured at 6 months only in intervention preschools
Other	Change in children's physical activity opportunities outside preschool time (process outcome)	Children's PA opportunities in terms of active transport and participation in organized sports will be assessed via a questionnaire (daily during the period that children are wearing the accelerometers) where parents answer time, duration and type of organized sports and mode of transportation to and from preschool. In addition, several parental practices (outdoor time during the weekend, parental perception of physical activity, parental physical activity, and active play with parents) which could potentially influence children daily physical activity levels will also be assessed by questionnaire.	Change from baseline to 6 months follow-up in children's physical activity opportunities outside preschool time
Other	Project evaluation from parents	How parents perceive and evaluate the intervention measured through questionnaire and interview.	Measured at 6 months (questionnaires and interviews)
Other	Project evaluation from preschool teachers	How preschool teachers perceive and evaluate the intervention measured through questionnaire and interview.	Measured at 6 months ((questionnaires and interviews)
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	Change in steps of teachers	Steps measured by Actigraph GT3X+	Change from baseline to 6 months follow-up in steps
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Project webside