Young 2018 (C).
Methods |
Study design: longitudinal cross‐over trial Unit and method of allocation: health subcentre communities randomly assigned to intervention and control Method of sequence generation: not reported Masking of participants, personnel, and outcome assessors: none (open label) |
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Participants |
Location of the study: West Champaran, Bihar, India Sample size: 100 households Age: 6 to 23 months Sex: 50% female in health centre 1 and 60% female in health centre 2 Socioeconomic status: not reported Baseline prevalence of anaemia: not reported Baseline prevalence of soil helminths: not reported Baseline malaria prevalence: not reported Inclusion and exclusion criteria: children aged between 6 and 23 months and not currently taking iron supplements were eligible for inclusion. Exclusion criteria included wasting (mid‐upper arm circumference < 11.5 cm); suspected severe anaemia (through assessment of palmar pallor); history of haemoglobinopathy or repeated blood transfusions; and currently ill with pneumonia, fever, or acute diarrhoea |
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Interventions | Two health centres selected, and within each, 50 households randomly selected
Duration of intervention: 2.5 months |
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Outcomes |
Primary: adherence, acceptability Secondary: maternal preferences for MNP vs iron folic acid supplements Timing of outcome assessment: adherence and acceptability assessed by survey at baseline, 1 month after first intervention, and 1 month after second intervention; maternal preferences assessed by semi‐structured intervention at end of month 1 and month 2 |
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Notes |
Study start date: December 2015 Study end date: April 2016 Conflict(s) of interest: none reported Funding source(s): Bill and Melinda Gates Foundation Malaria‐endemic area: yes Comment No primary or secondary outcomes reported, so no data included |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: randomised, but random sequence generation not described |
Allocation concealment (selection bias) | Unclear risk | Comment: not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: not blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: < 5% loss to follow‐up |
Selective reporting (reporting bias) | Low risk | Comment: no apparent selective reporting |
Other bias | Unclear risk | Comment: information insufficient to permit judgement |
CRP: C‐reactive protein. DMC: Data Monitoring Committee. ECD: early cognitive development. EDTA: ethylenediaminetetraacetic acid. EHFP: enhanced homestead food production. FBCFR: food‐based complementary feeding recommendation. FDP: food distribution point. Fe: iron. HAZ: height‐for‐age z score. Hb: haemoglobin. HDSS: Health and Demographic Surveillance System. HOME: Home Observation for Measurement of the Environment. IDA: iron deficiency anaemia. IFA: iron and folic acid. IYCF: Infant young child feeding LNS: lipid‐based nutrition supplement. MNP: micronutrient powder. MUAC: mid‐upper arm circumference. PASW: Predictive Analytics Software. PF: phenol formaldehyde resin. RBP: retinol binding protein. SPSS: Statistical Package for the Social Sciences. sTfR: soluble transferrin receptor. TfR: transferrin receptor. VDCs: village development committees. WAZ: weight‐for‐age z score. WHZ: weight‐for‐height z score.