Study Objectives
BRIGHTSAM is designed to answer four interconnected research questions about how nutrition and caregiving support shape recovery from severe acute malnutrition.
To assess the effects of a modified ready-to-use therapeutic food (RUTF) and psychosocial stimulation, individually and combined, on attention, cognitive, motor, language and psycho-emotional development in children treated for severe acute malnutrition (SAM).
To investigate the pathways of intervention effects on cognitive development by assessing the role of DHA and choline status in the child, as well as caregiver factors, including caregiver-child interaction, home stimulation, and maternal psychological distress.
To assess how, why and for whom the modified RUTF and psychosocial interventions work within the trial context; the perceived feasibility of implementing them within the routine health system; and the climate and environmental sustainability of the interventions.
To assess the perceptions and implementation feasibility within the routine health system, and the climate and environmental sustainability of interventions.
How the trial is structured
BRIGHTSAM uses a 2x2 factorial design, meaning children are randomly assigned to one of four groups: standard RUTF alone, modified (DHA- and choline-enriched) RUTF alone, standard RUTF combined with psychosocial stimulation, or modified RUTF combined with psychosocial stimulation. This design allows the research team to measure the independent and combined effects of the nutritional and psychosocial interventions on child development outcomes.