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. 2020 Jul 25;2020(7):CD012241. doi: 10.1002/14651858.CD012241.pub2

Fildes 2015.

Study characteristics
Methods Multi‐centre, individually randomised (ratio: 1:1), parallel‐group study design
Participants Study setting: UK, Greece, and Portugal between February 2011 and July 2012
Inclusion criteria: random sub‐sample of participants in a large study exploring children's fruit and vegetable acceptance during weaning was selected to participate in the study before initiation of complementary feeding. In the large study, 327 women in the final trimester of their pregnancy and mothers of infants younger than 6 months of age were eligible to participate if they were older than 18 years of age at recruitment and were sufficiently proficient in each country’s respective native language to understand the study materials, and if their infant was born after 37 weeks’ gestation, without diagnosed feeding problems
For this study, 146 mothers and infants were recruited: 75 (33 out of 68 (49%) males) in the intervention group and 71 (40 (57%) males) in the control group
Interventions Intervention group: counselling sessions either at home or at the paediatrician's office up to 4 weeks before initiation of complementary feedings. Session included advice on introduction of vegetables and the technique of exposure feeding for weaning and on vegetable intake and preference
Control group: usual care without any specific guidance, instructions, or information on weaning with vegetables
Outcomes Taste test with intake (g) of the novel vegetable as the primary outcome
Identification  
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Women in the final trimester of their pregnancy and mothers of infants younger than 6 months of age
Allocation concealment (selection bias) Low risk Women in the final trimester of their pregnancy and mothers of infants younger than 6 months of age
Blinding of participants and personnel (performance bias)
All outcomes High risk Because of the nature of the intervention, parents in the intervention arm and researchers delivering the intervention were not blind. The same researcher who delivered the intervention also delivered the taste test
Blinding of outcome assessment (detection bias)
All outcomes High risk The researcher present at the taste test was the same individual who delivered the intervention and therefore was not able to be blinded to the condition
Incomplete outcome data (attrition bias)
All outcomes Low risk 139 (95%) infants completed the study
Selective reporting (reporting bias) Low risk All proposed outcomes were reported
Other bias High risk A random sub‐sample of participants in a large study was used in this study. It is unclear how the sub‐sample of participants was selected as this may introduce bias to the study