Witt 2012

Methods	Study design: Cluster‐randomised controlled trial Funding: Not reported
Participants	Description: Children aged 4 or 5 years at 17 childcare centres N (Randomised): 17 childcare centres, 263 children Age: “The researchers were not permitted to obtain specific ages of each child but were informed by the centers’ directors that the majority of the children were 4 or 5 years old.” % Female: 47% SES and ethnicity: Not specified Inclusion/exclusion criteria: Not specified Recruitment: Not specified Recruitment rate: Unknown Region: Boise Idaho (USA)
Interventions	Number of experimental conditions: 2 Number of participants (analysed): Intervention: fruit = 83, vegetable = 70 Control: fruit = 70, vegetable = 52 Description of intervention: “Color Me Healthy comes in a ‘‘toolkit’’ that includes a teacher’s guide, 4 sets of picture cards, classroom posters, a music CD that contains 7 original songs, a hand stamp, and reproducible parent newsletters. Color Me Healthy is composed of 12 circle‐time lessons and 6 imaginary trips. The majority of the CMH circle‐time lessons focus on fruits and vegetables of different colors. Several of the lessons provide opportunities for children to try fruits and vegetables. The 6 imaginary trips included in CMH encourage children to use their imagination to explore places, be physically active, and eat fruits and vegetables. Six interactive take home activities were developed for the current evaluation. These interactive activities coincided with the circle‐time lessons.” Duration: 6 weeks Number of contacts: 24 (preschool = 2 circle‐time + 1 imaginary trip per week, each 15 ‐ 30 minutes, home = 6 interactive take home activities) Setting: Preschool + home Modality: Face‐to‐face Interventionist: Lead teachers Integrity: No information provided Date of study: Unknown Description of control: No treatment control: “During the study, comparison classrooms did not incorporate nutrition curriculum into their lesson plans.”
Outcomes	Outcome relating to children's fruit and vegetable consumption: Child’s consumption of fruit and vegetable snacks (grams). “To determine the amount of fruit and vegetable snack consumed, the fruit and vegetable snacks were weighed (in grams) before they were served to children and then weighed again after children had had an opportunity to consume the snack. Percentage of fruit and vegetable snack consumed was calculated for each child.” Outcome relating to absolute costs/cost effectiveness of interventions: Not reported Outcome relating to reported adverse events: Not reported Length of follow‐up from baseline: 7 weeks (1 week post‐intervention) and ˜ 5 months (3 months post‐intervention) Length of follow‐up post‐intervention: 1 week and 3 months Subgroup analyses: None Loss to follow‐up (at 3 months): Intervention: fruit = 50%, vegetable = 58% Control: fruit = 29%, vegetable = 47% Analysis: Adjusted for clustering Unknown sample size calculations performed
Notes	First reported outcome (mean number of pineapple snacks remaining) at the longest follow‐up (3 month follow‐up) was extracted for inclusion in meta‐analysis. Insufficient data available to enable inclusion in meta‐analysis (standard deviation not reported, nor available from authors) Sensitivity analysis ‐ primary outcome: Primary outcome not stated, fruit or vegetable intake is only reported outcome.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomly allocated to experimental group but the random sequence generation procedure is not described
Allocation concealment (selection bias)	Unclear risk	There is no information provided about allocation concealment and therefore it is unclear if allocation was concealed
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Fruit and vegetable snacks (weighed): Objective measure of child’s fruit and vegetable intake and unlikely to be influenced by performance bias
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Fruit and vegetable snacks (weighed): Objective measure of child’s fruit and vegetable intake and unlikely to be influenced by detection bias
Incomplete outcome data (attrition bias) All outcomes	High risk	Attrition rate > 20% for short‐term follow‐up. Only 58% of consenting children received fruit snacks at all 3 time points
Selective reporting (reporting bias)	Unclear risk	There is no study protocol therefore it is unclear if there was selective outcome reporting
Other bias	Unclear risk	Recruitment bias: it appears that parents were invited to participate after centres had been randomised, so unclear risk of bias Baseline imbalance: there are no baseline data comparing study groups, so we cannot tell if groups were balanced at baseline, so unclear risk of bias Incorrect analysis: “The current evaluation was a nested design; children were nested within classrooms. The classrooms were the units of assignment, but the outcome data were collected among the children.” HLM modelling accounted for clustering, therefore low risk of bias