Designing, validation and evaluation of an mHealth app for prenatal health promotion based on the unified theory of acceptance and use of technology: A mixed methods study protocol.

Educating pregnant women about health-promoting behaviors is essential for achieving optimal pregnancy outcomes. Mobile health (mHealth) technologies are increasingly used to enhance healthcare delivery and support positive lifestyle changes. However, for these interventions to be effective, they must align with users' socio-cultural contexts and expectations. This study aims to design, validate, and evaluate a culturally sensitive mHealth application for prenatal health promotion, guided by the Unified Theory of Acceptance and Use of Technology (UTAUT). An exploratory sequential mixed-methods design will be employed in three phases. In Phase 1, qualitative data will be collected through in-depth interviews with 15-20 pregnant women and healthcare experts to explore factors influencing the adoption of mHealth technologies. Data will be analyzed using directed content analysis based on the UTAUT model, following the approach proposed by Elo and Kyngäs. In Phase 2, the app will be developed using the ADDIE instructional design model. Findings from Phase 1 and a comprehensive literature review will inform the design of a prototype. The app will undergo expert review and user testing for content validation and usability assessment. In Phase 3, a randomized controlled trial will be conducted with 60 pregnant women recruited from public health clinics. Participants will be randomly assigned to either the intervention group (receiving the mHealth app) or the control group (receiving standard prenatal care) for one month. Outcomes will be assessed using the Modified Health-Promoting Lifestyle Profile for Pregnancy (both groups) and the UTAUT-based Technology Acceptance Questionnaire (intervention group only). Data will be analyzed using SPSS version 23. A mixed-methods integration strategy will be used to interpret results, illustrating how qualitative findings inform and elaborate the quantitative outcomes. This protocol outlines the development of a theory-driven, user-centered mHealth intervention designed for pregnant women. The use of a mixed-methods approach ensures that the app reflects user needs and evaluates its effectiveness in promoting maternal health behaviors, with potential implications for improving maternal and fetal health outcomes.Trial registration: The trial is registered at https//irct.behdasht.gov.ir (identifier IRCT ID IRCT20180412039276N2, registered on 23.05.2022).