- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03946241
Physical Activity in Schools After the Reform (PHASAR)
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
Condiciones
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
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Odense, Dinamarca, 5230
- Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
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
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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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.
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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).
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Pre-reform data have been collected between 1998 and 2012. Post-reform data have been collected during the school year 2017 to 2018.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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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.
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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).
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National BMI data have been obtained annually from 2011 and onwards. Thus, data from 2011 till 2018 will be utilized for this outcome.
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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.
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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).
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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.
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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.
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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).
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Anders Grøntved, PhD, University of Southern Denmark
- Investigador principal: Jens Troelsen, Professor, University of Southern Denmark
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
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
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
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