Physical ActivityNCT04569578
Increasing Children's Physical Activity by Policy (CAP)
A study testing Policy in people with Physical Activity and Sedentary Behavior, run by Karolinska Institutet at 1 site in Sweden.
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). Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Sedentary Behavior
- What is being tested?
- Policy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteSweden
- Study dates
- 23 Sep 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Children's Physical Activity by Policy (CAP): a Cluster Randomized Controlled Trial in the Stockholm Region Preschools
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.
Read the 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.
- Conditions
- Physical Activity, Sedentary Behavior
- Being tested
- Policy
- Keywords
- physical activity, preschool, randomized, intervention, sleep, sedentary behavior, sick leave
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolicyOther
The intervention will include:
- 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
| Study group | Role | What they receive |
|---|---|---|
| Policy | Experimental | The policy will be implemented on preschool level. Receives: Other: Policy |
| Regular practice | No intervention | The control preschool will continue their regular practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline 6 months follow-up in physical activity levels (daily minutes in moderate to vigorous physical activity)
Secondary outcomes (21)
Change in sedentary time of children
Daily sedentary time in minutes assessed by the Actigraph GT3X+
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 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
Measured: 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+
Measured: Change from baseline to 6 months follow-up in physical activity levels
Change in steps of teachers
Steps measured by Actigraph GT3X+
Measured: 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+
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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".
Measured: 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".
Measured: From 12 months prior the intervention starts and during the 6 months intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start23 Sep 2020
- Primary completion2 Jul 2021
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm County Council (Center of Epidemiology and Community Medicine)
- Responsible party
- Principal investigator, Daniel Berglind, Karolinska Institutet
- Investigators
- Daniel Berglind, Associate Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569578
- Sponsor's protocol ID
- CAP2020
- Status last verified
- Aug 2021
- First submitted
- 16 Sep 2020
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35854370
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Children's Physical Activity by Policy (CAP): a Cluster Randomized Controlled Trial in the Stockholm Region Preschools
- ClinicalTrials.gov ID
- NCT04569578
- Acronym / sponsor ID
- CAP2020
- Conditions
- Physical Activity, Sedentary Behavior
- Keywords
- physical activity, preschool, randomized, intervention, sleep, sedentary behavior, sick leave
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Stockholm County Council (Center of Epidemiology and Community Medicine)
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Policy | Experimental | Other: PolicyThe policy will be implemented on preschool level. |
| Regular practice | No intervention | –The control preschool will continue their regular practice. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolicyThe 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 | Other | Policy |
Primary outcome
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)
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
21 secondary outcomes
Change in sedentary time of children
Time frame: Change from baseline to 6 months follow-up in daily minutes in sedentary time
Change in musculoskeletal fitness of children
Time frame: Change from baseline to 6 months follow-up in musculoskeletal fitness (handgrip strength)
Change in anthropometry (weight in kg) of children
Time frame: Change from baseline to 6 months follow-up in anthropometry
Change in anthropometry (height in cm) of children
Time frame: Change from baseline to 6 months follow-up in anthropometry
Change in anthropometry (waist circumference in cm) of children
Time frame: Change from baseline to 6 months follow-up in anthropometry
Change in anthropometry (BMI) of children
Time frame: Change from baseline to 6 months follow-up in anthropometry
Change in psychosocial functioning of children
Time frame: Change from baseline to 6 months follow-up in psychosocial functioning
Change in sleep of children
Time frame: Change from baseline to 6 months follow-up in sleep
Sick leave duration of children
Time frame: From 12 months prior the intervention starts and during the 6 months intervention period
Sick leave frequency of children
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
Time frame: Change from baseline to 6 months follow-up in compliance with The WHO guidelines.
Change in physical activity levels of teachers
Time frame: Change from baseline to 6 months follow-up in physical activity levels
Change in steps of teachers
Time frame: Change from baseline to 6 months follow-up in steps
Change in sedentary time of teachers
Time frame: 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)
Change in anthropometry (weight in kg) of teachers
Time frame: 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
Change in anthropometry (waist circumference in cm) of teachers
Time frame: 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
Sick leave duration of teachers
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Derived from this study: PubMed 35854370Chen 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.
- Project websideLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Berglind, Associate Professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Policy in people with Physical Activity and Sedentary Behavior, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04569578, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.