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. 2018 May 17;2018(5):CD008552. doi: 10.1002/14651858.CD008552.pub5
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.”
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
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
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.
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