METHODS: We conducted a 9-month, parallel, multiarm, cluster-randomised controlled trial in 31 rural villages in Kishoreganj District, Bangladesh. Villages were randomly allocated to: group sessions ('group'); alternating groups and home visits ('combined'); or a passive control arm. Sessions were delivered fortnightly by trained community members. The primary outcome was child stimulation (Family Care Indicators); the secondary outcome was child development (Ages and Stages Questionnaire Inventory, ASQi). Other outcomes included dietary diversity, latrine status, use of a child potty, handwashing infrastructure, caregiver mental health and knowledge of lead. Analyses were intention to treat. Data collectors were independent from implementers.
RESULTS: In July-August 2017, 621 pregnant women and primary caregivers of children<15 months were enrolled (group n=160, combined n=160, control n=301). At endline, immediately following intervention completion (July-August 2018), 574 participants were assessed (group n=144, combined n=149, control n=281). Primary caregivers in both intervention arms participated in more play activities than control caregivers (age-adjusted means: group 4.22, 95% CI 3.97 to 4.47; combined 4.77, 4.60 to 4.96; control 3.24, 3.05 to 3.39), and provided a larger variety of play materials (age-adjusted means: group 3.63, 3.31 to 3.96; combined 3.81, 3.62 to 3.99; control 2.48, 2.34 to 2.59). Compared with the control arm, children in the group arm had higher total ASQi scores (adjusted mean difference in standardised scores: 0.39, 0.15 to 0.64), while in the combined arm scores were not significantly different from the control (0.25, -0.07 to 0.54).
CONCLUSION: Our findings suggest that group-based, multicomponent interventions can be effective at improving child development outcomes in rural Bangladesh, and that they have the potential to be delivered at scale.
TRIAL REGISTRATION NUMBER: The trial is registered in ISRCTN (ISRCTN16001234).
OBJECTIVES: We aimed to identify study-level and individual-level modifiers of the effect of SQ-LNSs on child hemoglobin (Hb), anemia, and inflammation-adjusted micronutrient status outcomes.
METHODS: We conducted a 2-stage meta-analysis of individual participant data from 13 randomized controlled trials of SQ-LNSs provided to children 6-24 mo of age (n = 15,946). We generated study-specific and subgroup estimates of SQ-LNSs compared with control, and pooled the estimates using fixed-effects models. We used random-effects meta-regression to examine potential study-level effect modifiers.
RESULTS: SQ-LNS provision decreased the prevalence of anemia (Hb < 110 g/L) by 16% (relative reduction), iron deficiency (plasma ferritin < 12 µg/L) by 56%, and iron deficiency anemia (IDA; Hb < 110 g/L and plasma ferritin <12 µg/L) by 64%. We observed positive effects of SQ-LNSs on hematological and iron status outcomes within all subgroups of the study- and individual-level effect modifiers, but effects were larger in certain subgroups. For example, effects of SQ-LNSs on anemia and iron status were greater in trials that provided SQ-LNSs for >12 mo and provided 9 (as opposed to <9) mg Fe/d, and among later-born (than among first-born) children. There was no effect of SQ-LNSs on plasma zinc or retinol, but there was a 7% increase in plasma retinol-binding protein (RBP) and a 56% reduction in vitamin A deficiency (RBP