Effect of a Participatory Whole-Systems Approach on Mortality in Children Younger than 5 Years in Jigawa State, Nigeria (INSPIRING trial): A community-based, parallel-arm, pragmatic, cluster randomised controlled trial and concurrent mixed-methods process evaluation

This study evaluates the impact of a participatory whole-systems approach on reducing mortality in children under 5 in Jigawa State, Nigeria. Utilising a community-based, cluster-randomized controlled trial with concurrent mixed-methods evaluation, 32 health care catchment areas were allocated to either intervention or control. The intervention, delivered from March 2021 to December 2022, comprised participatory learning and action (PLA) groups for men and women, partnership-defined quality scorecards (PDQS), and healthcare worker capacity building. The primary outcome, all-cause mortality among children aged 7 days to 59 months, showed no significant reduction (hazard ratio 0.95, p=0.79). While there were notable improvements in women’s knowledge about pneumonia, broader community health effects were limited. Qualitative data revealed barriers to intervention reach and highlighted cultural dynamics within compounds affecting community engagement. Findings suggest that enhancing child health outcomes in high-mortality regions may benefit from adapting participatory approaches to emphasize local community dynamics.