Namenek Brouwer 2013.

Study characteristics
Methods	Study design: cluster‐RCT Length of follow‐up from baseline: 4 months Unit of allocation: centre Unit of analysis: centre
Participants	Service type: centre‐based (licensed) Operation: not reported Country (region): USA (North Carolina) Country income classification: high Low‐SES sample: unclear Population description: not reported Inclusion criteria: to participate in the study, centres had to provide all foods and beverages to children in care (i.e. parents could not send food from home), not have an open case of abuse or neglect with the state licensing agency, and have at least 3 children between the ages of 3 and 5 years in care on a regular basis. Exclusion criteria: not reported Number of services randomised: 4 (2 interventions, 2 control) Number of children randomised: not reported (3 children from each classroom randomly selected for dietary outcome assessment) Characteristics Children Age: 3‐5 years Gender (% female): not reported Ethnicity: not reported Parents Age (years): not reported Gender (% female): not reported Ethnicity: not reported Parent/family SES: not reported ECEC staff Age (years): not reported Gender (% female): 100% Ethnicity: African American: 75% Service/ECEC staff SES: not reported Method of recruitment: a letter of invitation was mailed to every licensed centre (n = 6) in the city limits of a small community near the researchers' offices. The letter was followed by a telephone call from the study team. The first 4 centres that agreed to participate were enrolled. Centre directors provided written informed consent to participate in the study; parents were provided a fact sheet describing the study and were asked to contact the project director if they did not want their children observed during the dietary assessment. Missing data/dropout: not reported Reasons for dropout: not reported Characteristics of dropouts: not reported
Interventions	Programme name: Watch Me Grow Number of conditions: 1 intervention, 1 control Intervention duration: 4 months Intervention setting: ECEC Intervention strategies: Health curriculum Children Education: the programme included a "crop‐a‐month" structured curriculum highlighting the garden's targeted crop each month (lettuce, strawberries, spinach and broccoli). Ethos and environment Children Menu modification: garden produce was integrated onto service menu and children were provided taste testing activities. Centres were supported to increase the number and nutritional quality of vegetables and fruits provided to children in care, beyond what the garden would produce. Activities: providers and children grew: lettuce, strawberries, spinach and broccoli. Activities included reading, gardening, taste testing and songs. ECEC staff Education: the curriculum included an overview module, followed by monthly modules designed around a specific crop. Each month, the health educator described 4 discrete activities included in each module so that centre staff could deliver the activities to the children approximately weekly. Staff were encouraged to act as positive role models. Support: monthly technical assistance from a health educator to teachers. Email support for garden maintenance. Monthly visits to the provider at the centre who was directly responsible for food purchasing and menu planning. These visits were to help centres explore low‐cost, sustainable ways to increase the number and nutritional quality of vegetables and fruits provided to children in care. Service Environment: an 8′ × 4′ (approximately 2.5 m x 1.2 m) raised bed outdoor garden was installed at all intervention services. Resources: intervention classrooms received corresponding curriculum materials (including an existing published children’s book) highlighting the target fruit or vegetable of the month. The study provided all garden supplies, including plants, watering cans, brackets, and materials for the raised garden bed. Support: monthly consultation by a gardener Partnerships Families Event: 1‐h early spring kick‐off event at each intervention service. Parents and other family members, providers, and children were invited to help plant the gardens. Healthcare Support: a health educator met monthly with the provider at the centre who was directly responsible for food purchasing and menu planning. The intent was to help centres explore low‐cost, sustainable ways to increase the number and nutritional quality of vegetables and fruits provided to children in care, beyond what the garden would produce. Intensity of intervention: 1 x crop/month (with related class materials); 1 x installed garden in an appropriate location (plus gardening supplies, plus gardening expertise); 1‐h early spring kick‐off event; curriculum included overview modules, monthly module, 4 x activities provided to children weekly Intervention delivered by: research team, ECEC staff, healthcare staff Modality: face‐to‐face, written Theoretical basis: not reported Description of control: wait‐list control
Outcomes	Outcomes relating to child dietary intake: Fruit intake, vegetable intake, dark vegetable intake, white potato intake Number of participants analysed: Intervention baseline: 6 Intervention follow‐up: 6 Control baseline: 6 Control follow‐up: 6 Data collection measure: in‐care observation Data collector: trained registered dietitian Validity of measures used: validated Outcomes relating to child physical measures: not reported Outcome relating to child cognitive performance: not reported Outcome relating to child language and cognitive performance: not reported Outcome relating to child social/emotional measures: not reported Outcome relating to cost: not reported Outcome relating to adverse consequences: not reported
Notes	Funding source: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Following baseline data collection, centres were randomised via a simple randomisation scheme (randomisation without restriction) to either the intervention or control condition in a 1:1 ratio, using the Research Randomizer (http://www.randomizer.org/form.htm).
Allocation concealment (selection bias)	Low risk	Baseline data collected before centres were allocated to groups
Blinding of participants and personnel (performance bias) Diet outcomes	High risk	Teachers were aware of allocation and may have encouraged children to eat more fruits and vegetables on the days of diet observation.
Blinding of outcome assessment (detection bias) Diet outcomes	Low risk	Children's dietary intake was observed by a trained Registered Dietitian who was blinded to treatment group.
Incomplete outcome data (attrition bias) Diet outcomes	Unclear risk	There is no information regarding the number of participants at baseline or follow‐up. It is also unknown if the children observed at baseline were the same as those observed at follow‐up. Risk of attrition bias is unclear.
Selective reporting (reporting bias)	Unclear risk	No prospective trial protocol or trial registration so it was unclear whether there was selective outcome reporting
Recruitment bias	Low risk	Individual recruitment and child consent (opt‐out) to participate occurred before randomisation of clusters.
Baseline imbalance	Unclear risk	No baseline details on children provided; only details on the ECEC included
Loss of clusters	Low risk	Only 3 students were observed pre‐ and post‐interventions. Appears no ECEC was lost to follow‐up
Incorrect analysis	High risk	There was no accounting for clustering of children within centres.
Contamination	Unclear risk	All 4 centres were located within the city limits of a small community near the researchers' offices. Only 2 other centres existed in that community that were not chosen to participate. It is possible that ECEC staff from an intervention centre started working at a control centre, or for a child attending an intervention centre to switch to a control centre. However, there is not enough information provided to assess whether contamination exists.
Other bias	High risk	Study authors stated that “we randomly selected a classroom and then three children within that classroom for dietary observation at intervention and control centres before and after the intervention.” No further information is provided as to how classrooms and children were chosen. It is possible that choices were made in a biased way. No funding statement was provided.