Viewing Study NCT04569578



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Last Modification Date: 2024-10-26 @ 1:46 PM
Study NCT ID: NCT04569578
Status: UNKNOWN
Last Update Posted: 2021-09-01
First Post: 2020-09-16

Brief Title: Increasing Childrens Physical Activity by Policy CAP
Sponsor: Karolinska Institutet
Organization: Karolinska Institutet

Study Overview

Official Title: Increasing Childrens Physical Activity by Policy CAP a Cluster Randomized Controlled Trial in the Stockholm Region Preschools
Status: UNKNOWN
Status Verified Date: 2021-08
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 childrens PA behaviors in early stage of life 5 years Preschool policy is an organizational level factor associated with childrens 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 childrens 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 childrens PA and indicators of health Notably such robust evidence is urgently warranted as Swedish preschool childrens 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None