Toftager 2014.

Study characteristics
Methods	Study design: cluster‐RCT
Participants	School inclusion criteria: all municipalities in the Region of Southern Denmark were invited; 5 municipalities (Esbjerg, Nordfyn, Varde, Vejle, and Sønderborg) accepted the invitation and were asked to enrol public schools that contained Grade 8 School exclusion criteria: schools that were placed in the countryside and had more than 50% of all students living farther than 2 km Euclidian distance from the school, had a majority of students that were non‐native Danish Student inclusion criteria: — Student exclusion criteria: — Setting: school, mix Age group: children/adolescents Gender distribution: females and males Country/Countries where trial was performed: Denmark
Interventions	Intervention: intervention consisted of 11 intervention components changing the physical and organisational environment of schools. The multi‐component intervention was developed according to socioecological models of behavioural change and was constructed in accordance with existing knowledge‐based research and practical experiences from Danish school settings. A detailed written description of intervention components was delivered to all participating schools and included 4 physical environment changes and 7 organisational environment changes. Required physical environment changes included the following components: upgrade existing outdoor areas at the school for PA, including unfixed equipment; develop and build playgrounds specially designed for adolescents: play spots; improve safety for active transport to and from school; and establish an after‐school fitness programme Organisational environment changes included: formulate and implement school PA policy; educate teachers as ‘‘kick‐starters’’, who facilitate and motivate PA during recess; establish school play patrol: older students trained to initiate play and games for minors during school recess; mandatory outdoor recess and/or free access to gym or sports hall; school traffic patrol: older students helping minors cross the streets near the school; educate and train students in safe cycling; and  present school project or theme week once per year focused on learning about and doing PA during school lessons http://www.forebyggelsescenter.dk Comparator: — Duration of intervention: 2 years Duration of follow‐up: 2 years Number of schools: 14 Theoretical framework: socioecological model of behavioural change
Outcomes	PA duration Sedentary time Fitness
Study registration	ISRCTN79122411
Publication details	Language of publication: English Funding: other funding (funded by a non‐profit organisation) Publication status: peer‐reviewed journal
Stated aim for study	"The aim of the School site, Play Spot, Active transport, Club fitness and Environment Study was to develop, document, and assess a comprehensive intervention in local school districts that promote everyday PA among 11‐ to 15‐year‐old adolescents"
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: drew lots [author communication]
Allocation concealment (selection bias)	High risk	Comment: allocation not concealed [author communication]
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: participants not blinded to intervention group
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: outcome assessors not blinded [author communication]
Incomplete outcome data (attrition bias) Anthropometrics, Fitness	Low risk	Quote from publication: "out of the participating adolescents at baseline 13% (N = 162) had moved to another school at follow‐up, and 2% (N = 27) withdrew consent"
Incomplete outcome data (attrition bias) Physical activity and sedentary time	Low risk	Quote from publication: "out of the participating adolescents at baseline 13% (N = 162) had moved to another school at follow‐up, and 2% (N = 27) withdrew consent"
Selective reporting (reporting bias)	Low risk	Comment: all main outcomes in protocol reported
Cluster RCT ‐ Recruitment bias	High risk	Comment: individuals recruited and baseline measures taken after randomisation
Cluster RCT ‐ Baseline imbalance	Low risk	Comment: no baseline differences between groups
Cluster RCT ‐ Loss of clusters	Low risk	Comment: no clusters lost
Cluster RCT ‐ Incorrect analysis	Low risk	Comment: clustering of students within schools was accounted for by including schools as a random effect in analyses