Increasing Children's Physical Activity by Policy (CAP)

NCT04569578 | Unknown

• 1 other identifier: CAP2020
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Physical Activity; Sedentary Behavior

Keywords

physical activity; preschool; randomized; intervention; sleep; sedentary behavior; sick leave

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Change in sedentary time of children

  Change from baseline to 6 months follow-up in daily minutes in sedentary time

• Change in musculoskeletal fitness of children

  Change from baseline to 6 months follow-up in musculoskeletal fitness (handgrip strength)

• Change in anthropometry (weight in kg) of children

  Change from baseline to 6 months follow-up in anthropometry

• Change in anthropometry (height in cm) of children

  Change from baseline to 6 months follow-up in anthropometry

• Change in anthropometry (waist circumference in cm) of children

  Change from baseline to 6 months follow-up in anthropometry

Other Outcomes (6)

• Change in preschool policy and environmental characteristics (process outcome)

  Change from baseline preschool policy and environmental characteristics at 3 months and at 6 months

• Implementation of the policy package (process outcome)

  Measured weekly throughout 6 months only in intervention preschools

• Normalization of the policy package into preschool teachers' regular practice (process outcome)

  Measured at 6 months only in intervention preschools

Study Arms (2)

Policy

EXPERIMENTAL

The policy will be implemented on preschool level.

Other: Policy

Regular practice

NO INTERVENTION

The control preschool will continue their regular practice.

Interventions

Policy 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

Policy

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Stockholm County Council (Center of Epidemiology and Community Medicine): collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, 10431, Sweden

Location

Related Publications (1)

• 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.

  PMID: 35854370 DERIVED

Related Links

• Project webside

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior

Interventions

Policy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Health Care Economics and Organizations

Study Officials

• Daniel Berglind, Associate Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 30, 2020
• Study Start: September 23, 2020
• Primary Completion: July 2, 2021
• Study Completion: December 31, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)