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Increasing Children's Physical Activity by Policy (CAP)

31 agosto 2021 aggiornato da: Daniel Berglind, Karolinska Institutet

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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

4000

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Svezia
      • Stockholm, Svezia, 10431
        • Karolinska Institutet

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 3 anni a 5 anni (Bambino)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Policy
The policy will be implemented on preschool level.
Altro: 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
Nessun intervento: Regular practice
The control preschool will continue their regular practice.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in physical activity levels of children
Lasso di tempo: 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
Change from baseline 6 months follow-up in physical activity levels (daily minutes in moderate to vigorous physical activity)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in sedentary time of children
Lasso di tempo: 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 children
Lasso di tempo: 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 children
Lasso di tempo: 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)
Change from baseline to 6 months follow-up in anthropometry
Change in anthropometry (height in cm) of children
Lasso di tempo: 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 children
Lasso di tempo: 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 children
Lasso di tempo: 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
Change in psychosocial functioning of children
Lasso di tempo: Change from baseline to 6 months follow-up in psychosocial functioning
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.
Change from baseline to 6 months follow-up in psychosocial functioning
Change in sleep of children
Lasso di tempo: Change from baseline to 6 months follow-up in sleep
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.
Change from baseline to 6 months follow-up in sleep
Sick leave duration of children
Lasso di tempo: 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 children
Lasso di tempo: 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
Change in compliance with the World Health Organization (WHO) guidelines on physical activity, sedentary behaviour and sleep for children under 5 years of age
Lasso di tempo: Change from baseline to 6 months follow-up in compliance with The WHO guidelines.
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
Change from baseline to 6 months follow-up in compliance with The WHO guidelines.
Change in physical activity levels of teachers
Lasso di tempo: Change from baseline to 6 months follow-up in physical activity levels
Physical activity levels in terms of daily minutes in moderate to vigorous physical activity measured by Actigraph GT3X+
Change from baseline to 6 months follow-up in physical activity levels
Change in steps of teachers
Lasso di tempo: Change from baseline to 6 months follow-up in steps
Steps measured by Actigraph GT3X+
Change from baseline to 6 months follow-up in steps
Change in sedentary time of teachers
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in preschool policy and environmental characteristics (process outcome)
Lasso di tempo: Change from baseline preschool policy and environmental characteristics at 3 months and at 6 months
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.
Change from baseline preschool policy and environmental characteristics at 3 months and at 6 months
Implementation of the policy package (process outcome)
Lasso di tempo: Measured weekly throughout 6 months only in intervention preschools
Fidelity and dose of the implementation of the policy package will be documented through weekly feedback questionnaires throughout the intervention.
Measured weekly throughout 6 months only in intervention preschools
Normalization of the policy package into preschool teachers' regular practice (process outcome)
Lasso di tempo: Measured at 6 months only in intervention preschools
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.
Measured at 6 months only in intervention preschools
Change in children's physical activity opportunities outside preschool time (process outcome)
Lasso di tempo: Change from baseline to 6 months follow-up in children's physical activity opportunities outside preschool time
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.
Change from baseline to 6 months follow-up in children's physical activity opportunities outside preschool time
Project evaluation from parents
Lasso di tempo: Measured at 6 months (questionnaires and interviews)
How parents perceive and evaluate the intervention measured through questionnaire and interview.
Measured at 6 months (questionnaires and interviews)
Project evaluation from preschool teachers
Lasso di tempo: Measured at 6 months ((questionnaires and interviews)
How preschool teachers perceive and evaluate the intervention measured through questionnaire and interview.
Measured at 6 months ((questionnaires and interviews)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Karolinska Institutet

Collaboratori

Stockholm County Council (Center of Epidemiology and Community Medicine)

Investigatori

  • Investigatore principale: Daniel Berglind, Associate Professor, Karolinska Institutet

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 settembre 2020

Completamento primario (Effettivo)

2 luglio 2021

Completamento dello studio (Anticipato)

31 dicembre 2021

Date di iscrizione allo studio

Primo inviato

16 settembre 2020

Primo inviato che soddisfa i criteri di controllo qualità

23 settembre 2020

Primo Inserito (Effettivo)

30 settembre 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 settembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 agosto 2021

Ultimo verificato

1 agosto 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • CAP2020

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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