Pollitt 2000a.
| Methods | Study date: 2002. Study design: Cluster‐RCT. Randomised by day care. 3 Groups: Condensed milk + micronutrient. (2 of each age cohort). Skimmed milk + micronutrient (2 of each age cohort). Skimmed milk + placebo (3 groups for 6 months each. One 12‐month, one 18‐month, one 24‐month) | |
| Participants | SES or context: Low‐ and middle‐income country: Indonesia. Rural West Java. Children in government day care. Workers on tea plantation. Most were tea pickers; some were factory workers. A few had supplementary income. Income low; at time of study average was USD 68 ‐ USD 83 a month. Parental education averaged 3 years. Most families were Sudanese Nutritional status: Length for age ≦1 SD below mean. WFA between ‐1 and ‐2 SD of median Age: 2 cohorts. 12 and 18 months at enrolment Sex: Both Number: Experimental = 53 in 12‐month cohort, 83 in 18‐month cohort |
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| Interventions | Intevention: Feeding only. 2 intervention groups (see above) Energy: E group: 1171 kj + 12 mg iron; M Group: 209 kj + 12 mg iron, or S group: 104 kj with placebo pill (no micro‐nutrients). We compared E group to S group Duration: 12 months % DRI for energy: 6 ‐ 12 months = 26.1%, 12 ‐ 36 months = 21.4%, 36 ‐ 48 months = 12.9%, 48 ‐ 60 months = 12.3% % DRI for protein: Not enough information Control: Placebo Provider: Nestlé Foundation Supervised: Day‐care workers Compliance: Given at day care |
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| Outcomes | Physical: Weight Psychological: Standardised mental and cognitive assessment |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | By day care. Success was tested through inter‐group comparisons |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Baseline outcome measurements | Unclear risk | Means look the same for height and weight |
| Baseline characteristics | Unclear risk | Not applicable |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Difficult and complex to ascertain. No mention of attrition |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Tried to blind testers, but they noticed differences. However, they did switch testers around to avoid bias |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Controls received skimmed milk and experimental received condensed with micronutrient, and they were on different plantations, so they probably did not notice |
| Protection from contamination | Unclear risk | Not applicable |
| Selective reporting (reporting bias) | Unclear risk | No access to protocol |