Zask 2012.

Study characteristics
Methods	Study design: cluster‐RCT Length of follow‐up from baseline: 10 months Unit of allocation: preschool Unit of analysis: child
Participants	Service type: centre‐based (preschools) Operation: not reported Country (region): Australia (North Coast of New South Wales (NSW)) Country income classification: high Low‐SES sample: unclear Population description: not reported Inclusion criteria: preschools that submitted an expression of interest to participate Exclusion criteria: not reported Number of services randomised: 31 (18 intervention, 13 control) Number of children randomised: unclear (560 children participated) Characteristics Children Age: Girls: 50.5 months (SD 6.7) Boys: 58.8 months (SD 6.8) Gender (% female): 48.30% Ethnicity: not reported Parents Age (years): not reported Gender (% female): not reported Ethnicity: not reported Parent/family SES: not reported Method of recruitment: preschools that submitted an expression of interest to participate Missing data/dropout: records from 560 children (yielding a total of 1005 records with 537 and 468 records at pre‐ and postintervention) in 18 intervention and 13 control preschools were used in the study. Data were collected from 80.7% and 67.2% of all children enrolled pre‐ and postintervention respectively. Only 6.9% and 5.7% of enrolled children’s parents did not consent to participate at pre‐ and postintervention. Reasons for dropout: most of the missing data were due to children being absent on the day of testing or having left the preschool between consent and testing. Characteristics of dropouts: not reported
Interventions	Programme name: Tooty Fruity Vegie Number of conditions 1 intervention, 1 control Intervention duration: 10 months Intervention setting: ECEC Intervention strategies: Health curriculum Children Education: children received simple consistent messages about ‘sometimes’ and ‘everyday’ foods ‐ puppets, staff in fruit and vegetable costumes, stories, and role‐play, were used to reinforce this message. Structured 2 x/week fundamental movement skill development through prescribed games suitable for a wide age range. Ethos and environment Children Exposure: taste testing fruit and vegetables, growing and cooking used to reinforce nutrition messages. Role‐modelling: staff acting as role models and giving positive reinforcement to children about eating healthy food and drinking water. Service Audit and feedback: Project Management Committees reviewed playground environment and alterations to encourage more active movement and better access to sports equipment and water during free play times. Resources: small grants for sports equipment ECEC staff Training: preschool staff received a 1‐d training in running the ‘FunMoves’ programme. Resources: staff were given a kit comprising program notes and 30 laminated cards for each of the games. The cards were designed so that untrained parents or casual staff could quickly read the card and run the activity for 'FunMoves'. Environment: colourful posters on “better foods” and “foods better left out” on display all year. Drinking water made more accessible to children (so children could drink water without having to ask an adult for assistance). Policy: Project Management Committees worked with the team to review and adjust food and nutrition policies to explicitly identify appropriate and inappropriate foods in lunch boxes. Partnerships Families Workshop: health professional (dietitians, health promotion officer or child and family health nurse) delivered interactive workshops for parents on limiting sedentary time, promoting physical activity, fundamental movement skills and positive parenting in relation to healthy eating and feeding ‘fussy’ eaters, delivered by healthcare professionals. Parents were given support and practical, achievable advice to modify risk behaviours. Resources: a monthly 4‐page newsletter containing tips of healthy eating and active playing ideas was provided to each parent. Family Feud/ Food DVD was provided to parents, which models practical ways to improve children's eating habits Communication: communication of new policy to parents along with lunchbox displays Healthcare Engagement: health professionals (dietitians, health promotion officers and child and family health nurses) included in Project Management Committee and delivered the parent workshops. Intensity of intervention: twice‐weekly fundamental movement skills education for children; monthly 4‐page newsletter for parents; 1‐d staff training; parent workshops Intervention delivered by: ECEC staff, healthcare staff Modality: face‐to‐face, written Theoretical basis: The Health Belief Model and the Competence Motivational Theory. Capacity building and community participation theories were applied to build community action and ensure sustainability of the project Description of control: wait‐list control
Outcomes	Outcomes relating to child dietary intake: not reported Outcomes relating to child physical measures: BMI z‐score, waist circumference Number of participants analysed: Intervention baseline: 149‐335 Intervention follow‐up: 114‐286 Control baseline: 108‐163 Control follow‐up: 99‐152 Data collection measure: objectively measured Data collector: researcher Validity of measures used: 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: The Australian Better Health Initiative, a joint Australian, State and Territory government initiative, and supported by NSW Heath and the North Coast Area Health Service
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Preschools were randomly allocated to intervention or control groups in a ratio of approximately 1.4:1. The sequence generation procedure was not described.
Allocation concealment (selection bias)	Unclear risk	Study authors stated that "Preschools that acted as control schools in one year, were on a waiting list for an intervention and were offered the full program in subsequent years (the program continued beyond 2007). After random allocation to either intervention or control arms of the study, we compared preschool localities’ SES to ensure the groups were matched. No change in allocation was required. Six intervention and one control preschool participated in the pilot stage in 2006 to test the intervention’s feasibility. The 2006 control preschool became an intervention preschool in 2007 with additional 11 intervention and 12 control preschools."
Blinding of participants and personnel (performance bias) Physical outcomes	Low risk	No clear blinding of participants and personnel to study allocation, however the outcome is not likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) Physical outcomes	Low risk	Blinding not reported, however children's height, weight, and waist circumference were measured and were not likely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) Physical outcomes	Unclear risk	Study authors stated that “Data were collected from 80.7% and 67.2% of all children enrolled pre‐ and postintervention respectively. Most of the missing data were due to children being absent on the day of testing or having left the preschool between consent and testing.” Missing data is not reported by treatment group. Risk of attrition bias is unclear.
Selective reporting (reporting bias)	Low risk	The outcomes reported in the paper were prespecified in the protocol paper.
Recruitment bias	Unclear risk	It is unclear whether individuals were recruited to the study before or after randomisation of clusters.
Baseline imbalance	Unclear risk	Baseline data were reported, however not compared statistically. Study authors state that "The student and preschool variances have been accounted for in all models."
Loss of clusters	Unclear risk	Not reported
Incorrect analysis	Low risk	Study authors stated that "Data were further analysed by fitting multi‐level regression models in MLwiN to account for the clustered nature of the data (pre/post within students within preschools)."
Contamination	Unclear risk	No evidence to make assessment
Other bias	Unclear risk	Study authors stated that "There were reliability issues with waist circumference measurement so only data in which the same tester measured waist circumference pre and post intervention were included." There is insufficient information to assess whether an important risk of bias exists. No conflict of interest statement was reported.