Methods |
Study design: Randomised controlled trial Funding: Not reported |
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Participants |
Description: Children aged 4 to 8 months old and their parent N (Randomised): 100 parent‐child dyads Age: Mean: Repeated exposure = 6.3 months, Flavour‐flavour learning = 6.6 months, Flavour‐nutrient learning = 6.2 months Parent: not specified % Female: Child: Repeated exposure = 47%, Flavour‐flavour learning = 35%, Flavour‐nutrient learning = 38% Parent: mostly mothers (exact % not reported) SES and ethnicity: Not specified Inclusion/exclusion criteria: “The criteria for children inclusion were as follows: age between 4 and 8 mo, introduction of complementary foods was started at >2 wk and <2 mo before the start of the study, no health problems or food allergies at the beginning of the study, and gestational age ≥36 wk.” Recruitment: “Parents in the Dijon area of France were recruited using leaflets or posters distributed in health professionals consulting rooms, pharmacies, and day‐care centers.” Recruitment rate: Parent‐child dyads = 81% (100/123) Region: Dijon (France) |
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Interventions |
Number of experimental conditions: 3 Number of participants (analysed): Repeated exposure = 32 Flavour‐flavour learning = 30 Flavour‐nutrient learning = 30 Description of intervention: “During the exposure period, infants were exposed 10 times to a basic (RE group), a sweet (FFL group), or an energy‐dense (FNL group) artichoke puree according to their group.” Duration: Approx. 41 days Number of contacts: 2 ‐ 3 times per week Setting: Home Modality: Face‐to‐face Interventionist: Parents Integrity: “parents were given precise instructions, and data collected in the notebook revealed that they complied with the instructions.” Date of study: October 2010 and May 2011 Description of control: N/A |
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Outcomes |
Outcome relating to children's fruit and
vegetable consumption: Child’s consumption of varied artichoke purees (grams). “To measure intake, parents were asked to weigh each jar before and after consumption, using a digital kitchen scale (61 g, Soehnle) that we provided them with, and to record the weight in a notebook. After each observation, parents were required to reseal the jar(s) of food, freeze them, and bring the used jars back to the laboratory to check compliance with the study procedure and data accuracy.” 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: Unclear Length of follow‐up post‐intervention: 2 weeks, 3 months and 6 months Subgroup analyses: None Loss to follow‐up (at 2 weeks, 3 and 6 months): Overall = 5%, 7%, 8% Analysis: Sample size calculations 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: The interventions are all artichoke puree with different nutrient content. Parents would be unable to determine study group from feeding the child, and therefore this would be unlikely to influence the outcome |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Vegetable intake: This is objective assessment. Parents would be unable to determine study group from feeding the child, and therefore this would be unlikely to influence the outcome |
Incomplete outcome data (attrition bias) All outcomes | High risk | 5 families dropped out during the exposure period and were excluded. An intention‐to‐treat approach was not used and therefore at high risk of attrition bias |
Selective reporting (reporting bias) | Low risk | The outcomes reported in the paper align with those specified in the trial registration |
Other bias | Unclear risk | The groups differed significantly in relation to weaning, but this was adjusted for in analyses. Therefore the risk of other bias is unclear |