Shi 2009.
| Study characteristics | ||
| Methods | Cluster‐RCT | |
| Participants | Setting: Laishui County, Hebei Provence, northwest China Between April and September of 2006 Inclusion criteria: full term (gestational age > 37 weeks), singletons, without major birth defects, aged 2 to 4 months at the time of the baseline survey 599 infants enrolled from 8 clusters ‐ 294 (142 (48%) males) in the intervention group and 305 (162 (53%) males) in the control group |
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| Interventions | Intervention group: 4 major components: (1) group training sessions on food selection, preparation, and hygiene, childhood nutrition and growth, and responsive feeding style; (2) demonstrations of preparing enhanced weaning food recipes, which were formulated using locally available, affordable, acceptable, nutrient‐dense foods; (3) booklets that contained infant feeding guidance and methods of preparing recommended recipes; and (4) home visits every 3 months to identify possible feeding problems and to provide individual counselling Control group: received a standard package of child health care from township hospitals, which included breastfeeding counselling |
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| Outcomes | Weight change from 6 to 12 months Length change from 6 to 12 months WAZ, HAZ, and WHZ at 12, 15, and 18 months (in the Zhang 2013 paper) |
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| Identification | ||
| Notes | Standard deviation for changes in anthropometric measures from baseline were imputed via data provided in the paper; we used standard deviation for change (Bhandari 2001) Follow‐up data to 18 months with outcomes reported as z scores were published subsequently (Zhang 2013) Study was funded by Proctor and Gamble |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: ‘‘the paired townships were listed alphabetically in blocks of two and assigned randomly to be intervention or control sites’’ However, the method of randomisation is not clear |
| Allocation concealment (selection bias) | Unclear risk | Townships were listed alphabetically, but whether there was allocation concealment or not cannot be judged, as the method of randomisation is not described in sufficient detail |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | No information was provided. However, the intervention is not amenable to blinding of participants nor personnel delivering the intervention; outcomes included in this review are unlikely to be affected by lack of blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information was provided |
| Incomplete outcome data (attrition bias) All outcomes | High risk | At 12 months' follow‐up, the attrition rate was 19.9% in total (12.9% of infants from the intervention group and 23.3% of infants from the control group were missing) Reasons for loss to follow‐up are explained. However, unknown reason was higher in the control group at 16 (5.2%) than in the intervention group at 3 (1.0%) infants |
| Selective reporting (reporting bias) | Low risk | Study protocol is not available. However, all proposed outcomes have been reported |
| Other bias | High risk | At baseline, there were some differences in parental occupation between the 2 groups |