Impact of combined nutrition, responsive parenting, and health intervention on childhood development (BUNDLE) study - PROJECT SUMMARY Children in the USA and other contexts face multiple adversities in their environment which can be detrimental to their growth and development. Important among these are a lack of responsive parenting practices and early learning opportunities, poor nutrition and feeding practices, and high incidence of infectious diseases. The developmental potential realized if lack of responsive stimulation, malnutrition, and infection in young children are all addressed is unknown. Our study will test whether early childhood development in Liberia is improved by a bundled set of interventions that promote responsive stimulation and improved feeding by the provision of eggs and dried fish (nutrient-dense animal-source food) integrated into existing infection control activities of the national health system, and whether, in combination, these stimulation and feeding interventions will be more effective than responsive stimulation alone and the provision of animal-source foods alone. Our study will build on Plan International’s longstanding community-based intervention-delivery platform. In Bomi, Lofa, Nimba, and Margibi counties, we will rigorously test the effects of a 9-month group-based bundled intervention for female and male caregivers integrated into existing health services and delivered by trained adult community members on development of children 6 to 30 months of age. Using a four-arm 2x2 factorial cluster-randomized effectiveness design, rigorous intent-to-treat longitudinal models, and context-validated measures, we will compare cognitive, language, socio-emotional, and motor development of 2240 children from 160 communities randomized to a comparison arm or one of three intervention arms. Each arm will receive the national infection control activities. Three intervention arms will also receive: 1) responsive stimulation, 2) provision of eggs and dried fish for consumption by the children, or 2) responsive stimulation + provision of eggs and dried fish. Our study has three aims. First, we will test differences in child development (cognitive, language, socio-emotional, and motor) among children receiving the national infection control intervention (Arm 1), that intervention plus responsive stimulation (Arm 2), that intervention plus eggs and dried fish (Arm 3), and all interventions combined (Arm 4). Second, we will test the impact of the interventions on intermediate outcomes of the child (e.g., anthropometry, consumption of eggs and fish, morbidity) and caregivers (e.g., early learning opportunities, responsive feeding, responsive stimulation, mental health, social support, co-parenting) and whether improvements in the intermediate outcomes mediate effects on child development. Third, we will determine the cost-effectiveness of each intervention alone and of the full integrated intervention. This study presents an efficient opportunity to study the effects of a comprehensive set of early life inputs in vulnerable households, the results of which will be valuable to designing health systems interventions to protect child wellbeing in settings across the USA. Poor nutrition and development are experienced by populations across the USA, particularly in low income households. Early life is a critical period biologically, socially, and behaviorally. The nutritional and psychosocial needs in early childhood are universal, as are developmental processes throughout childhood.
