Methods |
Study design: Cluster‐randomised controlled trial Funding: "The research leading to these results has received funding from the European Community’s Seventh Framework Programme (FP7/2007‐2013) under the Grant Agreement No. FP7‐245012‐HabEat.” |
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Participants |
Description: Children aged 2 to 3 years from 5 nurseries in the Copenhagen area and suburbs N (Randomised): 104 children (“from 5 nurseries, involving 17 groups”) Age: Mean: Mere exposure group = 27.8 months, Flavour‐flavour learning group = 27.5 months, Flavour‐nutrient learning group = 30.8 months % Female: Mere exposure group = 63%, Flavour‐flavour learning group = 42%, Flavour‐nutrient learning group = 54% SES and ethnicity: Not specified Inclusion/exclusion criteria: Not specified Recruitment: “Children aged 2–3 years were recruited for the experiment from five nurseries, involving 17 groups, in the Copenhagen area and suburbs.” Recruitment rate: Unknown Region: Denmark |
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Interventions |
Number of experimental conditions: 3 Number of participants (analysed): Mere exposure group = 20 Flavour‐flavour learning group = 30 Flavour‐nutrient learning group = 21 Description of intervention: Mere exposure group, exposed to unmodified artichoke puree 10 times Flavour‐flavour learning group, exposed to a sweetened artichoke puree 10 times Flavour‐nutrient learning group, exposed 10 times to an energy dense artichoke puree with added fat Duration: 4 weeks Number of contacts: 10 exposures Setting: Preschool Modality: Face‐to‐face Interventionist: Nursery staff Integrity: No information provided Date of study: Unknown Description of control: N/A |
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Outcomes |
Outcome relating to children's fruit and
vegetable consumption: Child’s consumption of unmodified artichoke puree (grams). “Testing took part in group rooms. The children were seated at tables where they would normally eat their lunch to mimic the natural eating environment. The purées were served in preweighted plastic cups at room temperature. The standard serving size was 100 g for artichoke and 130 g carrot. Intake was measured individually and recorded for all sessions with a precision of 1 g.” 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: 5 and 8 months Length of follow‐up post‐intervention: 3 and 6 months Subgroup analyses: None Loss to follow‐up (at 3 and 6 months): Mere exposure group = 9%, 38% Flavour‐flavour learning group = 21%, 9% Flavour‐nutrient learning group = 23%, 46% Analysis: Adjusted for clustering (ANOVA proc mixed models). Unknown if sample size calculation was performed. |
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Notes | ||
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 intake: 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 intake: Intake was weighed and therefore it is unlikely that this would be influenced by detection bias |
Incomplete outcome data (attrition bias) All outcomes | High risk | Of 104 children, 71 (68%) completed the 6‐month follow‐up and therefore at high risk of attrition bias |
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 | The groups differed in age, but age was included as a covariate to correct for the possible influence on intake. Therefore the risk of other bias is unclear |