De Romana 2000.
| Methods | Study date: 2000. Study design: Cluster‐RCT, communities were chosen randomly as intervention or control communities (impact evaluation longitudinal with evaluations before and after the intervention) | |
| Participants | SES or context: Low‐ and middle‐income country: Peru. Area with high prevalence of infant malnutrition Nutritional status: 51% malnutrition in infants. High prevalence of diarrhoea, inadequate infant feeding practices, low prevalence of exclusive breastfeeding, and use of inadequate foods for complementary feeding Age: 6 ‐ 36 months Number: Experimental = 125, control = 125 Sex: Both |
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| Interventions | Intervention: Feeding only. Precooked food with instant preparation and high nutritional value. 100% of the iron, zinc, iodine, vitamin A and vitamin C requirements, and 60% of the other micronutrient Feeding compared to controls. Nutrition education, but not clear whether both groups got it Energy: 33% of energy requirements for 6 ‐ 36‐month‐old children, 20% of animal protein Reconstituted to provide 1 kcal/g Intensity: Daily Duration: 12 months % DRI for energy: 6 ‐ 12 months = 56.1%, 12 ‐ 24 months = 21.4% % DRI for protein: 6 ‐ 12 months = 148.86%, 12 ‐ 24 months = 130.55% Control: None Provider: Government of Peru and private sector Supervised: Not mentioned Compliance: Not mentioned |
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| Outcomes | Physical: Haemoglobin, height, and weight | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Says randomly chosen, but does not say how |
| Allocation concealment (selection bias) | Unclear risk | Not much information given in paper on how allocation was done |
| Baseline outcome measurements | Unclear risk | Some shown but not clear whether these are significantly different |
| Baseline characteristics | Unclear risk | Not applicable |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Data on initial numbers were reported, but outcome data were by percentage, very few numbers |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not really discussed, but probably difficult to blind as they gave food |
| Protection from contamination | Unclear risk | Not applicable |
| Selective reporting (reporting bias) | Unclear risk | No access to protocol |