Fildes 2015.
Study characteristics | ||
Methods |
Study design RCT Funding "This research is supported by European Community’s Seventh Framework Programme (FP7/2007‐2013) under the grant agreement no. 245012‐HabEat. The purees offered to participants in this study and the artichoke and peach purees used as a test food were donated by Danone Nutricia Research." |
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Participants |
Description Mothers and their 4‐ to 6‐month‐old infants in the UK, Greece and Portugal N (randomised) 146 parent‐infant dyads Age Child (mean): intervention = 39.0 weeks, control = 38.9 weeks Parent (mean, at child’s birth): intervention = 33.0 years, control = 32.7 years % Female Child: 52% Parent: 100% SES and ethnicity Parent: below university education = 27% Inclusion/exclusion criteria “Mothers were eligible to participate if they were over 18 years old at recruitment, they were sufficiently proficient in each country’s respective native language to understand the study materials and their infant was born after 37 weeks’ gestation, without diagnosed feeding problems.” Recruitment “Women in the final trimester of their pregnancy and mothers of infants aged less than 6 months were recruited from antenatal clinics (n 327), primary care, paediatricians and hospitals in London (UK), Athens (Greece) and Porto (Portugal) to a larger study exploring children’s fruit and vegetable acceptance during weaning.” Recruitment rate 45% (146/327) Region London (UK), Athens (Greece) and Porto (Portugal) |
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Interventions |
Number of experimental conditions 2 Number of participants (analysed) Intervention = 71, control = 68 Description of intervention “In the intervention group, a researcher or health professional explained to the participant: (1) the importance of introducing vegetables early in the weaning process, (2) the beneficial effects of offering different single vegetables each day, (3) the techniques of exposure feeding, (4) interpreting infants’ facial reactions to food and (5) the need for persistence when an infant initially rejects a food. “five vegetables were selected as the first foods to be introduced. They were asked to offer the five vegetables in a sequence over 15 d as follows: A,B,C,D,E, A,B,C,D,E, A,B,C,D,E and to record progress on a chart provided. For a further 5 d, participants were told to continue to offer vegetables, but in addition, to start to introduce additional age‐appropriate foods.” Duration 20 days (15 days exposure, 5 days veg plus other foods) Number of contacts 20 (15 veg feeding exposures, 5 veg plus other food exposures) Setting Home or health facility Modality Face‐to‐face and leaflet Interventionist Parent Integrity “Completed intervention charts were returned by 86% of intervention families (UK; 100 % (28/28), Greece; 100 % (16/16), Portugal; 63% (17/27)). Completed charts revealed that over the 15‐d intervention period, parents recorded their infants consuming vegetables on 89% (mean 13·3 (SD 3·0)) of the fifteen possible eating occasions.” Date of study February 2011 and July 2012 Description of control Received no intervention, ‘usual care’ |
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Outcomes |
Outcome relating to children's fruit and vegetable consumption Infant consumption of fruits and vegetables (grams). The contents of the jars of fruit and vegetable puree were weighed prior to and following the taste test to calculate the weight of food consumed. 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 1 month Length of follow‐up postintervention 2 weeks Subgroup analyses None Loss to follow‐up Intervention = 5% Control = 4% Analysis Sample size calculation was performed. |
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Notes | First reported outcome (vegetable intake) was extracted for inclusion in meta‐analysis. Sensitivity analysis ‐ primary outcome: fruit or vegetable intake is primary outcome |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised to experimental group using a block randomisation matrix created by an independent statistician |
Allocation concealment (selection bias) | Unclear risk | Allocation was revealed to the researcher, but unclear how or when |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Infant’s consumption of novel vegetable: Mothers offered and fed the vegetable to infants. Given the nature of the intervention, parents in the intervention arm were not blinded and therefore this could have influenced performance |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Infant’s consumption of novel vegetable: The outcome was weighed, but it is not clear who weighed the food (mother who fed the child, or researcher who observed the mother feeding the child). The researcher who was present during outcome assessment was the same researcher who delivered the intervention to the mother. The impact on detection bias is unclear |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 139/146 (95%) completed the follow‐up and therefore low 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 | Low risk | Contamination bias that could threaten the internal validity is unlikely to be an issue |