Pinket 2016.

Study characteristics
Methods	Study design: cluster‐RCT Length of follow‐up from baseline: 12 months Unit of allocation: municipalities Unit of analysis: child
Participants	Service type: centre‐based: (Germany: kindergartens; Bulgaria: kindergartens; Spain: kindergartens; Poland: kindergartens; Greece: kindergartens and day‐care centres; Belgium: preschool settings) Operation: not reported Country (region): 6 European countries (Belgium, Bulgaria, Germany, Greece, Poland and Spain) Country income classification: Belgium: high; Germany: high; Greece: high; Poland: high; Spain: high; Bulgaria: upper‐middle Low‐SES sample: unclear Population description: not reported Inclusion criteria: kindergartens were considered eligible for inclusion in the intervention if (i) they were located within a radius of 50 km around the local institutes; (ii) headmasters and teachers provided signed consent form and (iii) families’/children’s participation rate was at least 50%. Children within recruited kindergartens were eligible if (i) they were aged between 3.5 and 5.5 years at the time of recruitment (i.e. born between January 2007 and December 2008); (ii) their parents/caregivers provided a signed consent form and (iii) were not participating in any other clinical trial or other health‐oriented project during the academic years 2012–2013 and 2013–2014. Exclusion criteria: not reported Number of services randomised: 309 (groups not reported) Number of children randomised: 4964 (groups not reported) Characteristics Children Age: 4.7 years (SD 0.4) Gender (% female): 48.5% Ethnicity: not reported Parents Age (years): not reported Gender (% female): not reported Ethnicity: not reported Parent/family SES: SES (years of school education mother), % lower SES (= % ≤ 14 years of education): 38.5% Method of recruitment: not reported Missing data/dropout: not reported Reasons for dropout: not reported Characteristics of dropouts: not reported
Interventions	Programme name: The ToyBox‐intervention Number of conditions: 1 intervention, 1 control Intervention duration: 24 weeks in the school year Intervention setting: ECEC and home Intervention strategies: Health curriculum Children Education: teachers promoted the 4 targeted energy balance‐related behaviours (i.e. water consumption, snacking, physical activity and sedentary behaviour) on a regular basis and predefined time within each day, in the classroom/kindergarten. Teachers implemented interactive classroom activities, aiming at total class participation, minimum for 1 h/week. Ethos and environment Children Exposure: teachers remind children to drink water regularly and do short movement breaks twice in the morning and twice in the afternoon, arranging a daily break for the whole class to eat healthy snacks and performing 2 physical education sessions/week with a duration of 45 min each. Role modelling: teachers were also instructed to use the kangaroo hand puppet and perform these 4 topics, so as to enhance the effects of the intervention via role modelling ECEC staff Training: 2 x voluntary teacher training sessions to explain the programme and materials. An additional non‐compulsory training session was also offered. Teachers were not tested, but researchers provided certificates of attendance to the teachers as incentives. Resources: a box including the ToyBox‐intervention material (teacher's guide, classroom activity guide, kangaroo hand puppet) was provided to teachers. Service Environment: installation of water stations and the ‘magic snack plate’ to assist water and healthy snack consumption; rearrangements of the classroom/kindergarten to create some free space to assist children’s movement. Partnerships Families Resources: 9 x newsletters, 8 x tip cards and 4 x posters, coloured by their child, which aimed to encourage parents/caregivers to apply relevant environmental changes at home, act as role models and implement these lifestyle behaviours together with their children. Intensity of intervention: 3 x teacher training sessions; permanent environmental changes; teachers promote targeted behaviours every day; 2 x 45 min physical education lessons/week for children; 1 h/week interactive classroom activity; 9 x parent newsletters; 8 x parent tip cards; 4 x parent posters; 1 box of intervention materials provided to teachers. Intervention delivered by: research team, ECEC staff Modality: face‐to‐face, written Theoretical basis: PRECEDE‐PROCEED Model Description of control: usual care
Outcomes	Outcomes relating to child dietary intake: Plain yoghurt intake, cheese intake, fresh fruit intake, raw vegetable intake, sugared or aromatised yoghurt intake, chocolate and candy bars intake, milk‐based desserts intake, cake intake, biscuit intake, sugar‐based dessert intake, salty snack intake, healthy snack intake, unhealthy snack intake, unhealthy snacks intake, plain water intake, tea intake, soft drink intake, light soft drink intake, pure fruit juice intake, pre‐packaged fruit juice intake, smoothie intake, plain milk intake, sugared and chocolate milk, total water, fruit juice intake, soft drink intake, water intake Number of participants analysed: Intervention baseline: 3255 Intervention follow‐up: 3255 Control baseline: 1715 Control follow‐up: 1715 Data collection measure: FFQ Data collector: parent/caregiver Validity of measures used: validated Outcomes relating to child physical measures: not reported Outcome relating to child language and cognitive performance: not reported Outcome relating to child social/emotional measures: not reported Outcome relating to child quality of life: not reported Outcome relating to cost: not reported Outcome relating to adverse consequences: not reported
Notes	Funding source: Seventh Framework Programme (CORDIS FP7) of the European Commission under grant agreement n° 245200
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation of the recruited municipalities to intervention and control group was conducted centrally using Excel by the co‐ordinating centre in a 2:1 ratio within each SES strata.
Allocation concealment (selection bias)	Low risk	Allocation to intervention and control group was conducted centrally by the co‐ordinating centre, after the completion of baseline measurements.
Blinding of participants and personnel (performance bias) Diet outcomes	High risk	We assumed that due to the nature of the intervention, ECEC service staff and study personnel delivering the intervention were not blind to the study allocation. The outcome is likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) Diet outcomes	High risk	Parents reported children's dietary intake via a FFQ. Blinding of parents not reported, and the outcome measurement is likely to be influenced by a lack of blinding.
Incomplete outcome data (attrition bias) Diet outcomes	Unclear risk	Study authors stated that "Completer analysis was carried out to handle missing data, which means that only preschoolers with valid data at both baseline and follow‐up were included in the analyses." Data were available for 4970 (70%) of children whose parents consented to the study. No information is provided as to reasons for missing data or whether the loss or reasons for loss differed by intervention group. Risk of attrition bias is unclear.
Selective reporting (reporting bias)	Unclear risk	Outcomes are not clearly reported in the trial registration or trial protocol, so it was unclear whether there was selective outcome reporting.
Recruitment bias	Low risk	Individuals and centres were recruited before randomisation of municipalities. Randomisation of the municipalities to treatment group was conducted centrally by the co‐ordinating centre, after the completion of baseline measurements.
Baseline imbalance	Low risk	Descriptive analyses showed that there was no significant difference between the intervention and control groups regarding sex, age, intake of healthy snacks, and intake of unhealthy snacks at baseline. Clusters were stratified by SES prior to random selection and all analyses were corrected for preschool children's sex and age.
Loss of clusters	Unclear risk	There is a large number of missing data, however it is unclear if there were losses of clusters.
Incorrect analysis	Low risk	Study authors stated that "To take clustering of baseline and follow‐up measurements of preschool children in kindergarten classes in kindergartens into account, multilevel modeling was used."
Contamination	Low risk	Study authors stated that "After the recruitment of kindergartens and to avoid contamination between kindergartens in the same municipality, kindergartens’ municipalities were randomly assigned to the intervention or control group (2:1)." Therefore, contamination is unlikely.
Other bias	Low risk	No clear other source of bias