Morandi 2019.
| Study characteristics | ||
| Methods | Cluster‐RCT | |
| Participants | Study setting: primary paediatricians in the Veneto region (northeastern Italy) registered in their district list of primary care practitioners interested in research projects Inclusion criteria: healthy full‐term newborns whose parents or guardians had given their informed consent at the time of the first routine visit who were followed until the age of 2 years Exclusion criteria: preterm or post‐term birth or any congenital disorder, disease, or syndrome 562 infants were recruited: 295 (48% males) in the intervention group and 267 (50% males) in the control group. There is no baseline difference between groups of infants |
|
| Interventions | Intervention group: parents were provided with standardised oral and written nutrition education concerning protective practices at all routine visits scheduled during the children’s first 2 years of life (at 1, 3, 6, 12, and 24 months of age). Encouraged behaviours were breastfeeding, feeding on demand, responsive feeding, timely complementary feeding, giving portions based on the child’s appetite, alternating protein sources correctly, and playing active games with the child Control group: routine care and follow‐up |
|
| Outcomes | Change in weight and length between 6 and 12 months Exclusive breastfeeding at 3 months |
|
| Identification | ||
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Twenty‐two accepted and were randomly assigned 1:1 to the intervention or control arm using the random selection function of Microsoft Excel. The eleven 'intervention paediatricians' were asked to recruit at least 30 consecutive newborns during the first six months of the study" |
| Allocation concealment (selection bias) | High risk | Although paediatricians were randomly allocated to the intervention or control arm, they were aware of their patient's treatment allocation while recruiting the 30 patients from their practice |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | The intervention is not amenable to blinding of participants and personnel, but outcome measures relevant to this review are unlikely to be affected by lack of blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | The intervention is not amenable to blinding of participants and personnel, but outcome measures relevant to this review are unlikely to be affected by lack of blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 468 of 562 (83%) infants completed the study. There was no major difference in dropout rates across both groups (81% vs 85% in control vs intervention group) |
| Selective reporting (reporting bias) | Low risk | All proposed outcomes were reported |
| Other bias | High risk | Mother's professional category was higher in control group as compared to the intervention group at baseline |