Breastfeeding Education Support Tool for Baby - PROJECT SUMMARY Optimal infant feeding practices, including exclusive breastfeeding (EBF) for 6 months, play a critical role in determining the health, growth, and development of children, yet a large portion of infants in India lack the benefit of optimal feeding practices. Community-based programs directed at improving feeding practices of mothers in India are needed. The objective of this application is to conduct an effectiveness-implementation hybrid type I trial of our Breastfeeding Education Support Tool for Baby (BEST4Baby) intervention. BEST4Baby consists of prenatal and post-delivery breastfeeding education and support for mothers provided by community-based peer counselors who are trained in a 5-day WHO/UNICEF Breastfeeding Counselling Course and supported by an mHealth application. In Aims 1 and 2, we will test the effect of BEST4Baby on EBF for 6 months, infant growth velocity, and infant neurodevelopment. A cluster randomized controlled trial will be conducted in 4 sites across Karnataka State, India, with 16 Primary Health Subcenters (i.e., “clusters”) within each site randomized in a 1:1 ratio to one of two study arms (usual care [control] or BEST4Baby [intervention]). Eighteen pregnant women in each of the clusters (N=1,152) will receive either routine health education during the prenatal and postnatal period or 11 in-person BEST4Baby intervention visits (2 during pregnancy, 9 post-delivery) from peer- counselors. All participants will be followed longitudinally until their infants are 12 months of age to test the effect of assigned study arm on outcomes. In Aim 3, the RE-AIM framework and the Consolidate Framework for Implementation Research will guide our mixed-methods approach to evaluate BEST4Baby’s implementation and to identify implementation facilitators and barriers to inform sustainability and future adoption. Completion of this study will fill an evidence gap by demonstrating whether BEST4Baby is an effective mechanism to improve maternal behaviors and whether this intervention translates to improved clinical outcomes in infants. Findings from this project will also provide evidence needed to implement BEST4Baby across India and in other low resource communities. This project is guided by NICHD’s mission to enhance the lives of children. It aligns with four of NICHD’s cross-cutting scientific priorities - health disparities, disease prevention, nutrition, and global health - as well as NICHD’s Pediatric Growth and Nutrition Branch as BEST4Baby is aimed at promoting health during infancy, a critical period in human development. Given the lack of comprehensive prenatal and post-delivery breastfeeding support within the current India healthcare system and that India contributes one-fifth of all global live births, improving infant feeding practices of mothers in India, and thus improving infant health, could have major public and global health implications and we anticipate this research will be of significant impact.
