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. 2020 May 25;2020(5):CD008552. doi: 10.1002/14651858.CD008552.pub7

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."
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)
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’
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.
Notes First reported outcome (vegetable intake) was extracted for inclusion in meta‐analysis.
Sensitivity analysis ‐ primary outcome: fruit or vegetable intake is primary outcome
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