Effect of integrated responsive stimulation and nutrition interventions in the Lady Health Worker programme in Pakistan on child development, growth, and health outcomes: a cluster-randomised factorial effectiveness trial

Summary Background Stimulation and nutrition delivered through health programmes at a large scale could potentially benefit more than 200 million young children worldwide who are not meeting their developmental potential. We investigated the feasibility and effectiveness of the integration of interv... Full description

Summary Background Stimulation and nutrition delivered through health programmes at a large scale could potentially benefit more than 200 million young children worldwide who are not meeting their developmental potential. We investigated the feasibility and effectiveness of the integration of interventions to enhance child development and growth outcomes in the Lady Health Worker (LHW) programme in Sindh, Pakistan. Methods We implemented a community-based cluster-randomised effectiveness trial through the LHW programme in rural Sindh, Pakistan, with a 2 × 2 factorial design. We randomly allocated 80 clusters (LHW catchments) of children to receive routine health and nutrition services (controls; n=368), nutrition education and multiple micronutrient powders (enhanced nutrition; n=364), responsive stimulation (responsive stimulation; n=383), or a combination of both enriched interventions (n=374). The allocation ratio was 1:20 (ie, 20 clusters per intervention group). The data collection team were masked to the allocated intervention. All children born in the study area between April, 2009, and March, 2010, were eligible for enrolment if they were up to 2·5 months old without signs of severe impairments. Interventions were delivered by LHWs to families with children up to 24 months of age in routine monthly group sessions and home visits. The primary endpoints were child development at 12 and 24 months of age (assessed with the Bayley Scales of Infant and Toddler Development, Third Edition) and growth at 24 months of age. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT007159636. Findings 1489 mother–infant dyads were enrolled into the study, of whom 1411 (93%) were followed up until the children were 24 months old. Children who received responsive stimulation had significantly higher development scores on the cognitive, language, and motor scales at 12 and 24 months of age, and on the social–emotional scale at 12 months of age, than did those who did not receive the intervention. Children who received enhanced nutrition had significantly higher development scores on the cognitive, language, and social-emotional scales at 12 months of age than those who did not receive this intervention, but at 24 months of age only the language scores remained significantly higher. We did not record any additive benefits when responsive stimulation was combined with nutrition interventions. Responsive stimulation effect size