Lutter 2008.
| Methods | Study date: 2008. Study design: CBA | |
| Participants | SES or context: Low‐ and middle‐income country: Ecuador. Urban, peri‐urban and rural communities, low and insecure income, poor housing, and a general lack of 1 or more essential services (piped water, reliable electricity supply, sewage disposal) Nutritional status: Included all children in communities Age: 9 ‐ 14 months at enrolment Number: Experimental = 338 for anthropometry, 170 at end; 324 for morbidity, 324 at end. Control = 296 for anthropometry, 149 at end; 262 for morbidity, 262 at end |
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| Interventions | Intervention: Feeding with nutrition education. Supplement was a 65 g dry milk‐based product. Given to mothers to prepare once daily Energy: Provided 275 kcal/day and 10 g of protein, 6 g lipid Duration: 44 weeks % DRI for energy: 9 ‐ 12 months = 38.6%, 12 ‐ 14 months = 31.6% % DRI for protein: 9 ‐ 12 months = 108.0%, 12 ‐ 14 months = 114.30% Control: Usual diet Provider: National Food Nutrition Program administered by Ministry of Public Health Supervised: Yes. Weekly home visits with dietary recall Compliance. The supplement was consumed 73% of the time. Based on dietary recall, consumption was ½ of the daily ration Difference between study and control groups at end of study was 180 kcal. But says that daily energy increased by 240 kcal and iron by 9 mg |
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| Outcomes | Physical: Weight, length, anaemia, HAZ, WAZ, WHZ | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Non randomised study |
| Allocation concealment (selection bias) | High risk | Non randomised study |
| Baseline outcome measurements | Low risk | At baseline, program and control groups were similar with respect to many but not all variables (Table 3) |
| Baseline characteristics | Low risk | Field workers were trained and standardized using WHO guidelines |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | The 80% follow‐up by the team responsible for weekly morbidity surveillance was due to the fact that it was done by community health workers who could easily revisit the home to collect complete data. In contrast, the other teams travelled from the capital to the evaluation area for baseline and final measurements in the health clinics and had less flexibility to follow up with children who did not come to the clinic. Loss to measurement did not appear to bias these results; this was determined using the method described in the ‘‘Methods’’ in which a dummy variable indicating loss to follow‐up status was regressed on the variables in the regression models |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not specified in the study |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants aware of intervention |
| Protection from contamination | Low risk | Health centres in communities where the program began served as the program group and health centres in neighbouring, apparently similar communities, where the program was to be implemented 1 year later, served as the control group |
| Selective reporting (reporting bias) | Unclear risk | No protocol available |