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. 2018 May 17;2018(5):CD008552. doi: 10.1002/14651858.CD008552.pub5
Methods Study design:
Randomised controlled trial
Funding:
“This project was funded by Wageningen University and Research Centre.”
Participants Description:
Healthy infants between 4 and 7 months (not being weaned yet) and their parent
N (Randomised):
101 parent‐infant pairs
Age:
Child (mean): Green beans group = 162 days, Artichoke group = 160 days, Apple group = 165 days,
Plum group = 162 days
Mother (mean): Green beans group = 31 years, Artichoke group = 30 years, Apple group = 31 years, Plum group = 32 years
% Female:
Child: Green beans group = 54%, Artichoke group = 41%, Apple group = 56%, Plum group = 44%
Parent: 96%
SES and ethnicity:
Parents education: Low = 17%, middle = 32%, high = 50%
Inclusion/exclusion criteria:
Inclusion criteria: “Only healthy Children between 4 and 7 months old, who were not being weaned yet, were included in the study.”
Exclusion criteria: “Children with known food allergies, swallowing or digestion problems, or other medical problems that could influence the ability to eat, were excluded.”
Recruitment:
“The participants were recruited from the area of Wageningen and Almere in the Netherlands where both the research locations were. They were recruited via local newspapers, maternity or children welfare centers, postnatal care groups, and a mailing to subscribers of babyinfo.nl (a Dutch advertisement website that gives a box with free products for subscribers expecting a baby).”
Recruitment rate:
Unknown
Region:
Wageningen and Almere (The Netherlands)
Interventions Number of experimental conditions: 4
Number of participants (analysed):
Green beans group = 24
Artichoke group = 27
Apple group = 24
Plum group = 24
Description of intervention:
At the lab (days 1,2,17,18 and 19): “A bowl with two jars of vegetable purée was handed to the mother and the mother fed the infant at their usual rate until the end of the feeding was indicated by the infant (i.e. when it rejected the spoon more than three successive times).”
At the home (days 3 ‐ 16): “At the end of the 2nd test‐day at the lab, the mothers received the jars of puréed vegetables or fruits for the home exposure period. Each jar was labelled with the date on which it had to be fed to the infant and numbered from 3 to 16 corresponding to the respective days of the intervention period. The feeding was carried out every day at about the same time and in the same way as during days 1 and 2 in the lab.”
Duration:
19 days
Number of contacts:
9 exposure sessions
Setting:
Lab and home
Modality:
Face‐to‐face
Interventionist:
Researchers trained parents to offer the target vegetable or fruit puree to their child
Integrity:
No information provided
Date of study:
Unknown
Description of control:
N/A
Outcomes Outcome relating to children's fruit and vegetable consumption:
Consumption of target vegetable and fruit purees (grams).
At the lab: “The pre‐ and post‐weight of the bowl including the spoon and bib was weighted to measure the actual intake.”
At the home: “The mother was instructed to empty both jars completely on a plate and to put all what was left over after the feeding, including the vegetable purée that was spilled on the table, floor, bib, child’s face, etc., back in the jar and to seal the jar with the lid and put it in the refrigerator…. In order to have a standardized measure of home intake, the jars had been pre‐weighted in the lab before the home exposure period, and after they were collected and were post‐weighted again in the lab.”
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:
19 days
Length of follow‐up post‐intervention:
Immediately
Subgroup analyses:
None
Loss to follow‐up:
Overall = 2% (not specified by group)
Analysis:
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 High risk There is no indication whether the mother who fed the child was blind to group allocation. Given the mother fed the child, at high risk of performance bias
Blinding of outcome assessment (detection bias) All outcomes Unclear risk There is no indication whether the mother who fed the child and weighed the food was blinded to group allocation. Given the food was weighed by the mother the risk of detection bias is unclear
Incomplete outcome data (attrition bias) All outcomes Low risk 94% retention and therefore risk of attrition bias is low
Selective reporting (reporting bias) Unclear risk There is no study protocol, therefore it is unclear if there was selective outcome reporting
Other bias Low risk Contamination, baseline imbalance, & other bias that could threaten the internal validity are unlikely to be an issue