Leis 2020.

Study characteristics
Methods	Study design: cluster‐RCT Length of follow‐up from baseline: 9 months Unit of allocation: centre Unit of analysis: child
Participants	Service type: centre‐based (licensed child‐care centres or preschools) Operation: not reported Country (region): Canada (Saskatchewan and New Brunswick) Country income classification: high Low‐SES sample: unclear Population description: given the large area Saskatchewan represents (652 000 km2), it was decided to carry the study with selected early child‐care centres in the central region in year 1, and in the South and central‐North in years 2 and 3. Inclusion criteria: to be included in the study, an ECEC centre had to prepare and provide meals for lunch. This is required for assessing the quality of foods being served and for measuring nutritional intake. Exclusion criteria: centres with < 20 children between the ages of 3 and 5 were excluded. Number of services randomised: 61 (31 intervention, 30 control) Number of children randomised: 897 (464 intervention, 433 control) Characteristics Children Age: 4.1 years (SD 0.8) Gender (% female): Intervention: 49% Control: 46% Ethnicity: not reported Parents Age (years): not reported Gender (% female): not reported Ethnicity: not reported Parent/family SES: Median household income: Intervention: CAD 54,769 (SD 11,067) Control: CAD 54,773 (SD 10,790) Method of recruitment: selected ECEC centres were contacted, provided with information, and invited to participate in the project. Subsequently, ECEC centre directors were telephoned to answer their questions and to confirm their participation while securing the parents’ board support. Missing data/dropout: 1/61 centres dropped out (intervention); participants lost to follow‐up: 117 Reasons for dropout: change in centre management Characteristics of dropouts: no differences in baseline outcome food intake
Interventions	Programme name: Healthy Start‐Départ Santé (HSDS) Number of conditions: 1 intervention, 1 control Intervention duration: 6‐8 months Intervention setting: ECEC Intervention strategies: Ethos and environment ECEC staff Training: staff received 1 x 3‐h on‐site training sessions and were also offered a tailored 90‐min booster session at the midway point of the intervention period. The training session covered best practices in physical activity and healthy eating in early childhood, including topics such as the importance of physical activity and healthy eating for preschoolers, how to easily integrate physical activity and healthy eating in the ECEC’s daily routine, how to introduce and encourage children to try new and healthy foods, and how to help children develop their fundamental movement skills. Service Resources: services received an implementation manual, physical activity and healthy eating manuals, an active play equipment kit and other complementary resources for child‐care staff and families. Monthly newsletters were also sent to services, which included tips on how to get children moving or on how to improve healthy eating. Services were encouraged to share these newsletters with parents. Champion: services encouraged to identify a 'Healthy Star' – a staff member who was a champion for physical activity and healthy eating, and the point of contact for the programme co‐ordinators. Support: ongoing online and telephone support and monitoring. Partnerships Healthcare Delivery: training was delivered by specialists (dietitians, kinesiologists or other experts in the fields of nutrition and physical activity. Intensity of intervention: 3‐h training, ongoing online and telephone support and monitoring and 9‐ min booster session. Intervention delivered by: research team, ECEC staff, healthcare staff Modality: face‐to‐face, telephone, online, written Theoretical basis: not reported Description of control: wait‐list control
Outcomes	Outcomes relating to child dietary intake: Fibre intake, fruit and vegetable intake, sodium intake Number of participants analysed: Intervention baseline: 356 Intervention follow‐up: 356 Control baseline: 314 Control follow‐up: 314 Data collection measure: weighed plate waste enhanced with digital photography Data collector: not reported 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: Average cost of training, total intervention implementation cost Number of participants analysed: ECEC staff: 893 Trainers: 92 Data collection measure: intervention database and semi‐structured interviews with intervention staff Data collector: researchers Validity of measures used: not reported Outcome relating to adverse consequences: not reported
Notes	Funding source: a grant from the Public Health Agency of Canada (# 6282‐15‐2010/3381056‐RSFS), a research grant from the Consortium National de Formation en Santé (# 2014‐CFMF‐01), and a grant from the Heart and Stroke Foundation of Canada (# 2015‐PLNI). AFC was funded through a postdoctoral fellowship from the Saskatchewan Health Research Foundation and SW was funded through a Canadian Institutes of Health Research Charles Best Canada Graduate Scholarships Doctoral Award and a Gérard‐Eugène‐Plante Doctoral Scholarship from the Faculty of Medicine and Health Sciences at the Université de Sherbrooke.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Simple randomisation was used to allocate ECEC centres to either the intervention or control group with a 1:1 ratio.
Allocation concealment (selection bias)	Unclear risk	No information on the method of allocation concealment reported
Blinding of participants and personnel (performance bias) Diet outcomes	Unclear risk	While blinding was not possible for the ECEC centres, parents and children were not informed about group assignment. Research assistants responsible for collecting data were not told about the ECEC centre’s group allocation. It is unclear whether lack of blinding would affect the outcome. For example, teachers could have encouraged children to eat more healthy foods on the days of observation, though this is unknown.
Blinding of participants and personnel (performance bias) Cost	Unclear risk	Blinding was not possible for the ECEC centres. It is unclear whether the outcome is likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) Diet outcomes	Low risk	Children's dietary intake was measured using weighed plate waste enhanced with digital photography. Research assistants responsible for collecting data were not told of the centre's group allocation.
Blinding of outcome assessment (detection bias) Cost	Unclear risk	Blinding was not possible for the ECEC centres. It is unclear whether the outcome is likely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) Diet outcomes	High risk	Data were available for 356 (85%) children in the intervention group and 314 (85%) children in the control group at follow‐up. Study authors stated that "We used complete case analysis, such that only participants with complete outcome data were included. This represents a deviation from our original protocol, which planned for analyses to be pursued according to the intention‐to‐treat principle. This modification was necessary as the issue of missing data largely affected outcome variables, and it is generally the norm not to use imputation for missing data among outcome variables, especially when the proportion of missing data is large." Authors also stated that "Although not as susceptible to bias as a per‐protocol analysis, the complete case analyses used are associated with a higher risk that the study groups being compared differ in terms of potentially confounding variables that if the intention‐to‐treat principle were used." As a result, the risk of attrition bias is considered high.
Incomplete outcome data (attrition bias) Cost	Unclear risk	The number of participants or services which did not complete outcome follow‐up data for this outcome is unclear.
Selective reporting (reporting bias)	High risk	Dietary outcomes were reported for fibre (g), fruit and vegetable servings, and sodium (mg). Registration notes calories, macronutrients, and micronutrients. Anthropometric data not reported here
Recruitment bias	Unclear risk	It is unclear whether individuals were recruited to the study before or after randomisation of clusters.
Baseline imbalance	Low risk	Children in both groups were similar on all baseline characteristics.
Loss of clusters	Low risk	One cluster lost 9 children, but loss was a small percentage (< 5%) of the overall sample.
Incorrect analysis	Low risk	Study authors stated that "To account for clustering related to repeated measures and due to the sampling of participants in early childcare centres, variables representing participants and early childcare centres were included as random effects in all models."
Contamination	Low risk	Contamination unlikely. Study authors stated that "Following recruitment of one of the childcare centres in the usual practice arm, it was found that it had the same director and shared staff with a nearby early childcare centre which had been recruited in the intervention arm. Given the risk of contamination quasi certain it was decided to amalgamate the 2 centres as one intervention centre."
Other bias	Unclear risk	Deviations from protocol noted. Study authors stated that "The study protocol was implemented as planned; however, as detailed in the analysis section, the amount of missing data for the outcomes forced us to modify the analysis plan from an intention‐to‐treat to a complete‐cases analysis approach." There is insufficient information to assess whether an important risk of bias exists.