Impact of combined nutrition, responsive parenting, and health intervention on childhood development (BUNDLE) study

The National Institute of Child Health and Human Development awarded the University of South Carolina $1,751,704 on September 16, 2025, for a clustered-randomized effectiveness study testing bundled early childhood development interventions in Liberia under the Child Health and Human Development Extramural Research program (CFDA 93.865).

The study, titled the BUNDLE Study, will compare cognitive, language, socio-emotional, and motor development outcomes across 2,240 children ages 6 to 30 months from 160 communities in Bomi, Lofa, Nimba, and Margibi counties. Using a four-arm factorial design with intent-to-treat longitudinal analysis and context-validated measures, the research will test whether combined responsive parenting stimulation, provision of nutrient-dense animal-source foods (eggs and dried fish), and infection control activities improve developmental outcomes more effectively than single interventions or comparison conditions. All four study arms receive national infection control activities; three intervention arms additionally receive combinations of responsive stimulation and food provision. The 9-month group-based interventions will be delivered by trained adult community members and integrated into existing health services.

The period of performance runs from September 16, 2025, through June 30, 2030, with place of performance at Columbia, South Carolina.

Plan International Usa, Inc., serves as sub-recipient, executing major study activities including stakeholder engagement, staff hiring and training, equipment procurement, IRB coordination, formative research, data collector training, and ongoing field data collection and quality assurance. The Research Institute of the McGill University Health Centre serves as a sub-recipient providing intervention training, field data collection support, mixed-methods implementation evaluation design, and manuscript preparation.

Abstract

Children living in resource-limited settings 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 including diarrhea and malaria. 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 liberia'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 2160 children from 144 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. We hypothesize that child development will be improved in arms 2, 3, and 4 compared to arm 1, and in arm 4 compared to arms 2 and 3. This study will provide conclusive evidence of the effectiveness of a bundled intervention with implications for policy and programs aimed at improving child development.