Development and piloting of a primary school-based salt reduction programme: Formative work and a process evaluation in rural and urban Malawi.

Excess salt intake is a major modifiable risk factor for cardiovascular disease. Promoting salt reduction as part of routine school-health programming may be a pragmatic way to address this risk factor early in the life course but has not been tested in sub-Saharan Africa (SSA). Here we describe the formative work with stakeholders and process evaluation of pilot work to develop a school-based salt reduction programme for children aged 11-14 years, in preparation for a cluster-randomised trial in rural/urban Malawi. Collection of observational data and documentary evidence (meeting minutes/field notes) from the earliest key stakeholder engagement with Malawi Ministries of Health, Education, Local Government and Rural Development and Malawi Institute of Education, and non-governmental stakeholders; and a series of semi-structured interviews and focus groups (with head teachers (n = 2); teachers (n = 4); parents (n = 30); and learners (n = 40)). Data was analysed thematically and conceptualised through a Normalization Process Theory lens. Formative work illustrated a range of administrative, technical, and practical issues faced during development of the programme; including allocation of stakeholder roles and responsibilities, harmonisation with pre-existing strategies and competing priorities, resources required for programme development, and design of effective teaching materials. While participants were positive about the programme, the process evaluation identified features to be refined including perceived challenges to participation, recommended adaptations to the content and delivery of lessons, and concerns related to quantity/quality of learning resources provided. This study demonstrates the importance of comprehensive, sustained, and participatory stakeholder engagement in the development of a novel school health programme in SSA; and highlights the factors that were critical to successfully achieving this. We also demonstrate the value of detailed process evaluation in informing development of the programme to ensure that it was feasible and relevant to the context prior to evaluation through a cluster-randomised trial.