Evaluating the effects of a community-based Pre-Conception Care package through trained nurses on Pre-conception Health, Maternal and Child Health Outcomes: Protocol of a Stepped-wedge Cluster Randomized Implementation Trial

Objectives: The study aimed to evaluate the impact of village level preconception care (PCC) delivered by trained ANMs on preconception health and maternal child health outcomes among eligible women in rural Wardha, Maharashtra, India. It also sought to identify factors influencing the implementation and utilization of the PCC package, assess the feasibility of the intervention using the REAIM framework, and analyze the unit cost of delivering community based PCC interventions. Methods: Design: Open cohort stepped wedge cluster randomized design (swRCT) with repeated cross sectional sampling over three years, allowing phased implementation of the PCC package and systematic evaluation. Setting: Conducted in rural villages of Wardha Community Development block, integrated with the District Health System, using Village Council. Participants: Villages under four PHCs agreeing to Social Franchisee agreements were included. Eligible participants were women aged 19 to 45 years who had not completed their families, consented to participate, and resided in the study area for two years. Intervention &Comparator: The PCC package, delivered via village clinics, addressed nutrition, reproductive health, vaccination, and mental health, compared to routine government health services during the control period. Measurements: Data collection included baseline demographics, health behaviors (diet, physical activity, stress mediation), anthropometry, hemoglobin levels, and intervention compliance. Analysis used GLM regression models, with subgroup analysis on compliance and outcomes. Discussion: The PCC package, delivered by ANMs in rural Wardha, addresses undernutrition, anemia, and maternal depression. The implementation outcomes. Results and Conclusions: These will be assessed using the REAIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework, with the results anticipated to be published by the end of 2026, showcasing improved maternal child health and the feasibility of community based interventions in rural settings. Trial registration: CTRI/2024/03/064582 [Registered on: 21/03/2024] - Trial Registered Prospectively