NCT03946241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,018

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2019

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

2.3 years

First QC Date

May 6, 2019

Last Update Submit

April 28, 2026

Conditions

Keywords

School childrenPhysical ActivityAccelerometryBody mass indexImplementationPolicy

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

Secondary Outcomes (5)

  • Change in school children's BMI from the majority of all Danish public schools before, during, and after implementing the school reform.

    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.

    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.

    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.

    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.

    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.

Study Arms (2)

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.

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Sports Science and Clinical Biomechanics, University of Southern Denmark

Odense, 5230, Denmark

Location

MeSH Terms

Conditions

Motor ActivityOverweightSedentary Behavior

Condition Hierarchy (Ancestors)

BehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anders Grøntved, PhD

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR
  • Jens Troelsen, Professor

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 6, 2019

First Posted

May 10, 2019

Study Start

August 22, 2017

Primary Completion

December 2, 2019

Study Completion

June 1, 2022

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
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.
Access Criteria
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.
More information

Locations