Methods |
Study design: Randomised controlled trial Funding: “This project was funded by Wageningen University and Research Centre.” |
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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) |
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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 |
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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 |
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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 | 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 |