Methods |
Study design: Cluster‐randomised controlled trial – cross over Funding: “Financial support was provided by the Rudd Foundation.” |
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Participants |
Description: Children aged 3 to 6 years attending 2 private preschools in a small north‐eastern city N (Randomised): 2 preschools (number of children not specified, 96 children recruited) Age: “Age ranged from 3 to 6 years old, but most (85%) children were 4 or 5 years old.” % Female: 44% SES and ethnicity: “These preschools primarily serve highly educated households; nearly all (93%) of the children had at least one parent with a bachelor’s degree and 75% had at least one parent with a graduate or professional degree.” “Race/ethnicity was white (69%), Asian (8%), African American (5%), Hispanic (6%), and other (12%).” Inclusion/exclusion criteria: Not specified Recruitment: Not specified Recruitment rate: Unknown Region: New Haven (USA) |
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Interventions |
Number of experimental conditions: 2 Number of participants (analysed): Intervention = 43, control = 53 Description of intervention: “During the intervention, the children at Preschool A were served one of the new vegetables every day for 30 days in a 3‐day cycle (e.g., Monday, cauliflower; Tuesday, snow peas; Wednesday, green pepper) until they had received each vegetable a total of 10 times.” Duration: 6 weeks Number of contacts: 30 (1 per day for 30 days) Setting: Preschool Modality: Face‐to‐face Interventionist: Teachers Integrity: No information provided Date of study: 2007 Description of control: Control/delayed intervention (Preschool B). “ "Preschool B continued routine practices during the first 6 weeks of the study, and then switched conditions with Preschool A for the second 6 weeks” |
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Outcomes |
Outcome relating to children's fruit and
vegetable consumption: Child’s consumption of new vegetables (grams). “Researchers picked up the bags of vegetables later from the schools, weighed them, and calculated intake to the nearest gram.” 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: 12 weeks Length of follow‐up post‐intervention: Immediately Subgroup analyses: None Loss to follow‐up: No loss to follow‐up Analysis: Adjusted for clustering (multilevel modelling) Sample size calculations performed |
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Notes | Post‐intervention data were extracted
following the first phase of the trial (Time 2)
prior to cross‐over. As an estimate was not
reported for the Time 2 follow‐up that
adjusted for clustering, we used
post‐intervention data and calculated an
effective sample size using ICC of 0.014 to enable
inclusion in meta‐analysis. Sensitivity analysis ‐ primary outcome: Fruit or vegetable only outcome reported |
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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 | Vegetable consumption: Objective measure of child’s vegetable intake and unlikely to be influenced by performance bias |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Vegetable consumption: Objective measure of child’s vegetable intake and unlikely to influence detection bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There is no reported attrition. Data from 96 children were analysed |
Selective reporting (reporting bias) | Unclear risk | There is no study protocol therefore it is unclear if there was selective outcome reporting |
Other bias | High risk | Baseline imbalances were reported. There were differences in vegetable consumption at baseline |