Protocol for pre-pregnancy care mobile health app: Development, validation and usability testing with a human-centered design approach

Despite decades of healthcare initiatives, Malaysia’s maternal mortality ratio has plateaued at concerning levels, partly due to underutilized pre-pregnancy care (PPC) services. This study aims to develop, validate, and evaluate a PPC checklist mobile health (mHealth) app for Malaysian women. Using a three-phase, human-centered design (HCD), phase 1 employs a qualitative study to develop a culturally adapted PPC checklist through nominal group techniques with women (n = 8) and experts (n = 9), followed by content validation (n = 7). Phase 2 creates a prototype based on self-determination theory (SDT) and the Wheel of Sukr, integrating gamification features, and conducting face validation with users (n = 10). Phase 3 employs a cross-sectional survey to evaluate usability through the validated Malay version of the mHealth app usability questionnaire with 117 female outpatients across government clinics in Selangor. The HCD approach guides iterative development through continuous user feedback, ensuring contextual relevance, while SDT informs the design of gamification features by supporting autonomy, competence, and relatedness. Expected outcomes include a culturally validated PPC checklist prototype with good usability. This study offers a novel, theory-driven digital tool to enhance PPC service engagement and utilization in Malaysia and other similar healthcare settings.