Increasing Children's Physical Activity by Policy (CAP)

NCT ID: NCT04569578

Last Updated: 2021-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

4000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-23

Study Completion Date

2021-12-31

Brief Summary

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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

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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

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Physical Activity Sedentary Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Policy

The policy will be implemented on preschool level.

Group Type EXPERIMENTAL

Policy

Intervention Type OTHER

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

Regular practice

The control preschool will continue their regular practice.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Policy

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stockholm County Council (Center of Epidemiology and Community Medicine)

UNKNOWN

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Daniel Berglind

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Berglind, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska Institutet

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 35854370 (View on PubMed)

Related Links

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Other Identifiers

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CAP2020

Identifier Type: -

Identifier Source: org_study_id

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