Clinical trial NCT03946241: Physical Activity in Schools After the Reform
Official title: Physical Activity in Schools After the Reform
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Physical Activity
Overweight
Physical Inactivity
Keywords: School children
Physical Activity
Accelerometry
Body mass index
Implementation
Policy
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
name: University of Cambridge
First posted: 2019-05-10
Enrollment: 5200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Pre-reform data have been collected between 1998 and 2012. Post-reform data have been collected during the school year 2017 to 2018.
Secondary outcomes:
measure: Change in school children's BMI from the majority of all Danish public schools before, during, and after implementing the school reform.
timeFrame: National BMI data have been obtained annually from 2011 and onwards. Thus, data from 2011 till 2018 will be utilized for this outcome.
measure: Changes in BMI among school children before and after implementing the school reform.
timeFrame: 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.
measure: Changes in waist-to-height ratio among school children before and after implementing the school reform.
timeFrame: 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.
measure: 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.
timeFrame: 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.
measure: The total amount of physical activity in school children during school time, leisure time and total time before and after the school reform.
timeFrame: 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.
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
Study officials:
affiliation: University of Southern Denmark
name: Anders Grøntved, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern Denmark
name: Jens Troelsen, Professor
role: PRINCIPAL_INVESTIGATOR
References: