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Physical Activity in Schools After the Reform (PHASAR)

2 de mayo de 2022 actualizado por: Anders Groentved, University of Southern Denmark

In 2014 the Danish Government introduced a wide-ranging school reform that applies to all public schools in Denmark. In a physical activity promotion perspective, a distinctive feature of the school reform is that it has become mandatory to integrate an average of 45 minutes of daily physical activity in the regular school day. The overarching objective of the PHASAR study is to evaluate the implementation of this ambitious policy-driven physical activity promotion initiative and its potential effect on physical activity and overweight.

The PHASAR study provides a rare opportunity to evaluate the effectiveness of a nation-wide policy-driven school-based physical activity promotion initiative.

Descripción general del estudio

Estado

Activo, no reclutando

Descripción detallada

In 2014 the Danish Government introduced a wide-ranging school reform that applies to all public schools in Denmark. The reform involved changes in several aspects of the school structure and content. In a physical activity promotion perspective, a distinctive feature of the school reform is that it has become mandatory to integrate an average of 45 minutes of daily physical activity during the regular school day. The overarching objective of the PHASAR study is to evaluate the implementation of this ambitious policy-driven physical activity promotion initiative and the possible effect on children's level of physical activity and overweight. Moreover, by applying improved accelerometry technology, the study aims to provide a detailed characterization of physical activity during the children's entire day including the school day.

The evaluation is divided into a quantitative effect evaluation and a combined quantitative and qualitative process evaluation. A total of 31 schools were enrolled and 2,683 pairs of accelerometers were handed out to school-aged children from 1st to 9th grade in the PHASAR study during the 2017/18 school year. The objectively measured physical activity data will be compared to repeated cross-sectional data collected in four historical school-based studies from 1998-2012. Body mass index data from 2012-2018 will be collected from The Child Database, which includes repeated cross-sectional assessments on approximately 100,000 children annually. In the absence of a control group, interrupted time-series analysis will be used to evaluate pre- and post-reform physical activity and body mass index levels and trends. A characterization of the school environment relevant for physical activity promotion on a political, environmental, organizational and individual level, as well as school implementation processes will be conducted to evaluate the implementation process. Data will be collected using interviews, surveys, document analyses and observations.

The PHASAR study provides a rare opportunity to evaluate the effectiveness of a nation-wide policy-driven school-based physical activity promotion initiative. The use of objectively measured pre- and post-reform physical activity and body mass index data combined with a characterization of the school implementation processes regarding the promotion of physical activity will provide a comprehensive source of information needed to evaluate the school reform.

Tipo de estudio

De observación

Inscripción (Anticipado)

5200

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Odense, Dinamarca, 5230
        • Department of Sports Science and Clinical Biomechanics, University of Southern Denmark

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

6 años a 17 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Pre-reform studies:

School children in 1st to 9th grade (ages between 6 and 17 years). The participating children's parents or legal guardians.

Post-reform studies:

School children in 1st to 9th grade (ages between 6 and 17 years). The participating children's parents or legal guardians. Teachers, pedagogues, and headmasters from the same schools.

Descripción

Inclusion criteria:

Pre-reform study population:

- School children who been included in one of the four pre-reform studies.

Post-reform study population:

- Children attended one of the public schools and age groups that had already been included in one of the four pre-reform studies.

Exclusion criteria:

- School children that suffers from physical disabilities or injuries preventing physical activity.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Pre-reform study populations
Children from 1st to 9th grade (n ~ 2,600) from four different school-based studies collecting objective physical activity data. The four studies are 1) The European Youth Heart Study (EYHS) conducted in 1997-98, 2003-04 and 2009-10, 2) When Cities Move Children (WCMC) conducted in 2010 and 2012, 3) Childhood Health, Activity, and Motor Performance School Study Denmark (CHAMPS-DK) conducted in 2009, 2010 and 2012, and 4) School site, Play Spot, Active transport, Club fitness and Environment (SPACE) conducted in 2010 and 2012. A total of 44 schools where included in the studies.
Post-reform study population
Children from 1st to 9th grade in 2017-18 from the same schools as included in the pre-reform research studies (n ~ 2,600). Two of the pre-reform research studies (CHAMPS-DK and SPACE) introduced PA promoting initiatives as part of the study. To minimize any influence from participation in these interventions we chose only to include and recruit participants from control schools from these studies. A total of 36 schools where invited and 31 subsequently accepted to participate. Parents and teachers of the children were included as well.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in levels of school time physical activity, reported as time spent moving, in a representative sample of school children before and after the school reform.
Periodo de tiempo: Pre-reform data have been collected between 1998 and 2012. Post-reform data have been collected during the school year 2017 to 2018.
Objectively measured physical activity data are obtained via accelerometers mounted on the hip of the school children for a representative number of consecutive days. The school children's time spent moving will be longitudinally analysed on the school level (not class or individual level).
Pre-reform data have been collected between 1998 and 2012. Post-reform data have been collected during the school year 2017 to 2018.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in school children's BMI from the majority of all Danish public schools before, during, and after implementing the school reform.
Periodo de tiempo: National BMI data have been obtained annually from 2011 and onwards. Thus, data from 2011 till 2018 will be utilized for this outcome.
Height and weight are obtained from the Child Database (Børnedatabasen), which is based on data from the mandatory examinations in schools by school nurses on three occasions during children's years in public school. The first measurement is conducted at the age of 6 to 7 years of age (in case of several measurements, the first was registered). The second measurement is conducted when children were between 9 and 13 years old (in case of several measurements, the measurement closest to the age of 11 was registered). The third measurement is conducted when children were 14 or 15 years old (in case of several measurements, the last was registered).
National BMI data have been obtained annually from 2011 and onwards. Thus, data from 2011 till 2018 will be utilized for this outcome.
Changes in BMI among school children before and after implementing the school reform.
Periodo de tiempo: Data will be obtained from the pre-reform research studies in the years leading up to the school reform and the data collected during the school years 2017/18 and 2018/19.
School levels of changes in BMI will be compared in the pre- and post-reform study populations and analysed according to school levels of physical activity (child time spent moving).
Data will be obtained from the pre-reform research studies in the years leading up to the school reform and the data collected during the school years 2017/18 and 2018/19.
Changes in waist-to-height ratio among school children before and after implementing the school reform.
Periodo de tiempo: Data will be obtained from the pre-reform research studies in the years leading up to the school reform and the data collected during the school years 2017/18 and 2018/19.
School levels of changes in waist-to-height ratio will be compared in the pre- and post-reform study populations (were available) and analysed according to school levels of physical activity (child time spent moving).
Data will be obtained from the pre-reform research studies in the years leading up to the school reform and the data collected during the school years 2017/18 and 2018/19.
Change in time spent in moderate to vigorous physical activity in school children during school time, leisure time and total time from before till after the school reform.
Periodo de tiempo: Data will be obtained from the pre-reform research studies in the years leading up to the school reform and the data collected during the school years 2017/18 and 2018/19.
In order to investigate the effect of the school reform on health-related physical activity, change in time spent in moderate to vigorous physical activity (assessed by hip worn accelerometer) for school children before and after the school reform will the analysed.
Data will be obtained from the pre-reform research studies in the years leading up to the school reform and the data collected during the school years 2017/18 and 2018/19.
The total amount of physical activity in school children during school time, leisure time and total time before and after the school reform.
Periodo de tiempo: Data will be obtained from the pre-reform research studies in the years leading up to the school reform and the data collected during the school years 2017/18 and 2018/19.
The total amount of physical activity in school children during school time, leisure time and total time assessed using hip worn accelerometer will be reported as counts per minute for school children before and after the school reform.
Data will be obtained from the pre-reform research studies in the years leading up to the school reform and the data collected during the school years 2017/18 and 2018/19.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Anders Grøntved, PhD, University of Southern Denmark
  • Investigador principal: Jens Troelsen, Professor, University of Southern Denmark

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

22 de agosto de 2017

Finalización primaria (Actual)

2 de diciembre de 2019

Finalización del estudio (Anticipado)

1 de junio de 2022

Fechas de registro del estudio

Enviado por primera vez

6 de mayo de 2019

Primero enviado que cumplió con los criterios de control de calidad

9 de mayo de 2019

Publicado por primera vez (Actual)

10 de mayo de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de mayo de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

2 de mayo de 2022

Última verificación

1 de mayo de 2022

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 72682
  • 115606 (Otro número de subvención/financiamiento: TrygFonden)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

IPD will be anonymised and handed over to the Danish National Archives. From there researchers can request the database for additional or new analyses.

Marco de tiempo para compartir IPD

The data are expected to be available latest on the 1st of august 2027. It is likely that it will be available from approximately 2021. After data has been handed over, there is no expiry of availability.

Criterios de acceso compartido de IPD

For the first 20 years after the data has been handed over to the Danish National Archives the inquirer can get access to the data if the PI of the project accepts the inquiry. After this, there is no restrictions on availability.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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