Evaluating a community-based care package delivered by trained nurses to improve preconception and maternal-child health: protocol of a stepped-wedge cluster randomised trial.

Introduction: Preconception care (PCC) plays a pivotal role in improving maternal and child health outcomes by addressing health risks and promoting healthy behaviours before pregnancy. This study aimed to evaluate the impact of village-level PCC delivered by trained auxiliary nurse midwives on preconception health and maternal-child health outcomes among eligible women in central Maharashtra, India. It also sought to identify factors influencing the implementation and utilisation of the PCC package, assess the feasibility of the intervention using the Reach, Effectiveness, Adoption, Implementation, and Maintenance(RE-AIM) framework and analyse the unit cost of delivering community-based PCC interventions. Methods and analysis: This study follows an open cohort stepped-wedge cluster randomised design with repeated cross-sectional sampling over 3 years, allowing phased implementation of the PCC package and systematic evaluation. It is being carried out in rural villages of the Wardha Community Development block, working closely with the District Health System and local Village Councils. The study includes 96 villages (clusters) under four primary health centres that agreed to a social franchisee model and an estimated 3200 eligible women. Women aged 19-45 years who had not completed their families, gave consent and had lived in the area for at least 2 years were eligible to participate. The PCC package, delivered through village clinics by trained community nurses, focuses on improving nutrition, reproductive health, vaccination coverage and mental health. This will be compared with routine government services provided before the intervention. Information collected includes participants' background, lifestyle habits such as diet and physical activity, stress levels, physical measurements, haemoglobin levels and how well the intervention was followed. The data will be analysed using regression models, including subgroup analysis based on participation and outcomes. The PCC package is expected to help reduce undernutrition, anaemia and maternal depression. The implementation will be evaluated using the RE-AIM framework, and final results are expected by the end of 2026, demonstrating the effectiveness and practicality of providing PCC through community health systems in rural areas. Ethics and dissemination: Ethical approval was obtained from the Institutional Ethics Committee of Mahatma Gandhi Institute of Medical Sciences, India (IEC/406/2023, dated 30 December 2023) prior to trial initiation. Study findings will be disseminated through peer-reviewed publications and presentations at national and international conferences. In addition, results will be shared with participating communities, Village Health, Nutrition and Sanitation Committees, district and state health authorities through stakeholder meetings. Trial registration number: CTRI/2024/03/064582.