- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04569578
Increasing Children's Physical Activity by Policy (CAP)
Increasing Children's Physical Activity by Policy (CAP): a Cluster Randomized Controlled Trial in the Stockholm Region Preschools
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Stockholm, Sweden, 10431
- Karolinska Institutet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Policy
The policy will be implemented on preschool level.
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The intervention will include: i. Formalized physical activity policies implemented in preschools including the following:
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 |
No Intervention: Regular practice
The control preschool will continue their regular practice.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in physical activity levels of children
Time Frame: Change from baseline 6 months follow-up in physical activity levels (daily minutes in moderate to vigorous physical activity)
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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
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Change from baseline 6 months follow-up in physical activity levels (daily minutes in moderate to vigorous physical activity)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in sedentary time of children
Time Frame: Change from baseline to 6 months follow-up in daily minutes in sedentary time
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Daily sedentary time in minutes assessed by the Actigraph GT3X+
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Change from baseline to 6 months follow-up in daily minutes in sedentary time
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Change in musculoskeletal fitness of children
Time Frame: Change from baseline to 6 months follow-up in musculoskeletal fitness (handgrip strength)
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Musculoskeletal fitness, in terms of handgrip strength ,will be measured by an analogue dynamometer (TKK 5825, Grip-A, Takei, Tokyo, Japan).
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Change from baseline to 6 months follow-up in musculoskeletal fitness (handgrip strength)
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Change in anthropometry (weight in kg) of children
Time Frame: 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)
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Change from baseline to 6 months follow-up in anthropometry
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Change in anthropometry (height in cm) of children
Time Frame: Change from baseline to 6 months follow-up in anthropometry
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Height will be measured by validated scales (portable stadiometer: Seca 213, Seca, Chino, CA, USA)
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Change from baseline to 6 months follow-up in anthropometry
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Change in anthropometry (waist circumference in cm) of children
Time Frame: 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
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Change from baseline to 6 months follow-up in anthropometry
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Change in anthropometry (BMI) of children
Time Frame: Change from baseline to 6 months follow-up in anthropometry
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Weight and height will be combined to report BMI in kg/m^2
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Change from baseline to 6 months follow-up in anthropometry
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Change in psychosocial functioning of children
Time Frame: Change from baseline to 6 months follow-up in psychosocial functioning
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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.
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Change from baseline to 6 months follow-up in psychosocial functioning
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Change in sleep of children
Time Frame: Change from baseline to 6 months follow-up in sleep
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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.
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Change from baseline to 6 months follow-up in sleep
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Sick leave duration of children
Time Frame: From 12 months prior the intervention starts and during the 6 months intervention period
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Sick leave duration in terms of total days of leave will be collected from the Stockholm City smartphone application "Anmäl frånvaro".
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From 12 months prior the intervention starts and during the 6 months intervention period
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Sick leave frequency of children
Time Frame: From 12 months prior the intervention starts and during the 6 months intervention period
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Sick leave frequency in terms of total occasions of leave will be collected from the Stockholm City smartphone application "Anmäl frånvaro".
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From 12 months prior the intervention starts and during the 6 months intervention period
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Change in compliance with the World Health Organization (WHO) guidelines on physical activity, sedentary behaviour and sleep for children under 5 years of age
Time Frame: Change from baseline to 6 months follow-up in compliance with The WHO guidelines.
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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
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Change from baseline to 6 months follow-up in compliance with The WHO guidelines.
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Change in physical activity levels of teachers
Time Frame: Change from baseline to 6 months follow-up in physical activity levels
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Physical activity levels in terms of daily minutes in moderate to vigorous physical activity measured by Actigraph GT3X+
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Change from baseline to 6 months follow-up in physical activity levels
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Change in steps of teachers
Time Frame: Change from baseline to 6 months follow-up in steps
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Steps measured by Actigraph GT3X+
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Change from baseline to 6 months follow-up in steps
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Change in sedentary time of teachers
Time Frame: 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 from baseline to 6 months follow-up in daily minutes in sedentary time
|
Change in musculoskeletal fitness of teachers
Time Frame: 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 from baseline to 6 months follow-up in musculoskeletal fitness (handgrip strength)
|
Change in anthropometry (weight in kg) of teachers
Time Frame: Change from baseline to 6 months follow-up in anthropometry
|
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
Time Frame: 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 from baseline to 6 months follow-up in anthropometry
|
Change in anthropometry (waist circumference in cm) of teachers
Time Frame: 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 from baseline to 6 months follow-up in anthropometry
|
Change in anthropometry (BMI) of teachers
Time Frame: Change from baseline to 6 months follow-up in anthropometry
|
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
Time Frame: 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".
|
From 12 months prior the intervention starts and during the 6 months intervention period
|
Sick leave frequency of teachers
Time Frame: 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".
|
From 12 months prior the intervention starts and during the 6 months intervention period
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in preschool policy and environmental characteristics (process outcome)
Time Frame: Change from baseline preschool policy and environmental characteristics at 3 months and at 6 months
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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.
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Change from baseline preschool policy and environmental characteristics at 3 months and at 6 months
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Implementation of the policy package (process outcome)
Time Frame: Measured weekly throughout 6 months only in intervention preschools
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Fidelity and dose of the implementation of the policy package will be documented through weekly feedback questionnaires throughout the intervention.
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Measured weekly throughout 6 months only in intervention preschools
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Normalization of the policy package into preschool teachers' regular practice (process outcome)
Time Frame: Measured at 6 months only in intervention preschools
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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.
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Measured at 6 months only in intervention preschools
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Change in children's physical activity opportunities outside preschool time (process outcome)
Time Frame: Change from baseline to 6 months follow-up in children's physical activity opportunities outside preschool time
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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.
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Change from baseline to 6 months follow-up in children's physical activity opportunities outside preschool time
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Project evaluation from parents
Time Frame: Measured at 6 months (questionnaires and interviews)
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How parents perceive and evaluate the intervention measured through questionnaire and interview.
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Measured at 6 months (questionnaires and interviews)
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Project evaluation from preschool teachers
Time Frame: Measured at 6 months ((questionnaires and interviews)
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How preschool teachers perceive and evaluate the intervention measured through questionnaire and interview.
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Measured at 6 months ((questionnaires and interviews)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Berglind, Associate Professor, Karolinska Institutet
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CAP2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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