Zask 2012.

Study characteristics
Methods	Study name: Tooty fruity vegie Study design: cluster‐RCT Intervention period: 10 months Follow‐up period (post‐intervention): nil Differences in baseline characteristics: NR Reliable outcomes: reported Protection against contamination: NR Unit of allocation: pre‐school Unit of analysis: individual accounting for clustering
Participants	N (control baseline) = 163 (data were collected from 80.7% at baseline) N (control follow‐up) = 152 N (intervention baseline) = 335 (data were collected from 80.7% at baseline) N (intervention follow‐up) = 286 Setting (and number by study group): 31 preschools (18 intervention and 13 control) Recruitment: preschools in the New South Wales North Coast area (N = 40) were asked to submit an expression of interest to participate in the programme. 30 preschools volunteered and the team determined that it would have the capacity and resources to provide the intervention to 18 of them Geographic region: north coast of New South Wales, Australia Percentage of eligible population enrolled: 75% preschools volunteered and 18 were chosen Mean age: intervention + control: 50.5 ± 6.7 months girls; 58.8 ± 6.8 months boys Sex: intervention + control: 48.3% female
Interventions	Aimed to decrease overweight and obesity prevalence among children by improving fundamental movement skills, increasing fruit and vegetable intake and decreasing unhealthy food consumption PA interventions Structured twice‐weekly fundamental movement skill development through prescribed games suitable for a wide age range Playground environment review and alterations to encourage more active movement and better access to sports equipment during free play times. Small grants for sports equipment. Workshop for parents on limiting sedentary time, promoting PA and fundamental movement skills A monthly 4‐page newsletter containing tips of healthy eating and active playing ideas was provided to each parent. Healthy eating interventions Review and adjustment of food and nutrition policies to explicitly identify appropriate and inappropriate foods in lunch boxes. Communication of new policy to parents along with lunchbox displays Colourful posters on 'better foods' and 'foods better left out' on display all year Distribution of the 'Family feud/food' DVD, which models practical ways to improve children's eating habits, for their parent library Parents' workshops on positive parenting in relation to healthy eating and feeding ‘fussy’ eaters Simple consistent messages for children about ‘sometimes’ and ‘everyday’ foods; puppets, staff in fruit and vegetable costumes, stories, role‐play, growing, cooking, and taste‐testing fruit and vegetables were all used to reinforce this message Staff acting as role models and giving positive reinforcement to children about eating healthy food and drinking water Drinking water made more accessible. Healthy eating interventions Review and adjustment of food and nutrition policies to explicitly identify appropriate and inappropriate foods in lunch boxes. Communication of new policy to parents along with lunchbox displays Colourful posters on 'better foods' and 'foods better left out' on display all year Distribution of the 'Family feud/food' DVD, which models practical ways to improve children's eating habits, for their parent library Parents' workshops on positive parenting in relation to healthy eating and feeding ‘fussy’ eaters Simple consistent messages for children about ‘sometimes’ and ‘everyday’ foods; puppets, staff in fruit and vegetable costumes, stories, role‐play, growing, cooking, and taste‐testing fruit and vegetables were all used to reinforce this message Staff acting as role models and giving positive reinforcement to children about eating healthy food and drinking water Drinking water made more accessible. Preschools that acted as control schools in 1 year, were on a waiting list for an intervention and were offered the full programme in subsequent years (the programme continued beyond 2007). Diet and PA combination intervention vs control
Outcomes	Outcome measures Primary outcome: fundamental movement skills, fruit and vegetable served in lunchbox, unhealthy items in lunchbox, zBMIs, waist circumference, food intake, PA and sedentary behaviours Secondary outcomes: not clear which outcomes were primary/secondary Process evaluation: NR
Implementation‐related factors	Theoretical basis: NR Resources for intervention implementation: reported (not much detail) Who delivered the intervention: NR PROGRESS categories assessed at baseline: gender PROGRESS categories analysed at outcome: NR Outcomes relating to harms/unintended effects: NR Intervention included strategies to address diversity or disadvantage: NR Economic evaluation: NR
Notes	Funding: NR Of the 1005 records collected, there were 966 complete records of lunch box audits (96.1%), 952 complete records for anthropometric measures (94.7%), 789 complete records of fundamental movement skills testing (78.5%), and 699 returned parent surveys (69.6%). Waist circumference data were only available in 498 cases in 18 preschools (10 intervention and 8 control) as records in other preschools were deemed unreliable. Small grants for sports equipment, no further details
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quote: "A random allocation in a ratio of approximately 1.4:1. 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. Overall, there were 18 intervention and 13 control preschools. Data from both 2006 and 2007 preschools were used in the final analyses." Comment: it is not clear whether this study is fully randomised.
Allocation concealment (selection bias)	High risk	As above
Blinding (performance bias and detection bias) All outcomes	High risk	Unlikely to be blinded, especially when 1 control school became an intervention school
Incomplete outcome data (attrition bias) All outcomes	High risk	Data were collected from 80.7% and 67.2% of all children enrolled pre‐ and post‐intervention respectively. In addition, 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
Selective reporting (reporting bias)	Unclear risk	Protocol and trial registry report sought but not found
Other bias	Low risk	No additional threats to validity
Other bias‐ timing of recruitment of clusters	Low risk	Recruitment happened before randomisation.

ANCOVA: analysis of covariance; ASE: Attitude, social influence and self‐efficacy model; BEM: Behavioral Ecological Model; BMI: body‐mass index; CCHC: childcare health consultants; CDC: Centers for Disease Control and Prevention; CI: confidence interval; cluster‐RCT: cluster‐randomised controlled trial; CSA accelerometer: computer sciences applications accelerometer; CV: cardiovascular; DEXA: dual X‐ray absorptiometry; FAS: full analysis sample; FV: fruit and vegetables; GEMS: Girls’ health enrichment multisite studies; HBM: Health Belief Model; HDL‐C: high‐density lipoprotein cholesterol; HOMA‐IR: homeostatic model assessment of insulin resistance; IMB model: information‐motivation‐behavioural skills model; IMD: Index of Multiple Deprivation; ITT: intention to treat; LDL‐C: low‐density lipoprotein cholesterol; LGA: local government area; LOCF: last observation carried forward; MD: mean difference; MET: metabolic equivalent; MI: Motivational Interviewing; MVPA: moderate to vigorous physical activity; N: number; NDS‐R: Nutrition Data System computer program; N/A: not applicable; NIH: National Institutes of Health; NR: not reported; PA: physical activity; PE: physical education; PROGRESS: Place, race, occupation, gender, religion, education, socio‐economic status, social status) checklist; PSHE: personal, social and health education; RCT: randomised controlled trial; RT: resistance training; SAPAC: self‐administered physical activity checklist; SCT: Social Cognitive Theory; SD: standard deviation; SE: standard error; SEM: Social Ecological Model; SES: socioeconomic status; SSB: sugar‐sweetened beverages; TPB: Theory of Planned Behaviour; TSF: triceps skinfold; TTM: Transtheoretical Model (Stages of Change); TV: television; WHCU: weight/height cubed; WIC: women’s, infants’ and children’s centre; zBMI: body‐mass index z score