A theory-based mobile health application for gestational weight management: Protocol for a randomized controlled trial

Background Gestational weight gain (GWG) is a critical factor affecting maternal and fetal health. Excessive GWG increases the risk of complications and contributes to the prevalence of overweight and obesity among women of reproductive age. Despite existing guidelines, many pregnant individuals struggle to manage GWG effectively. Therefore, theory-based and evidence-informed interventions that provide continuous support are urgently needed. Mobile health (mHealth) applications have emerged as promising, cost-effective, and accessible tools for promoting healthy behaviors during pregnancy. This study describes the development of a theory-based mHealth application guided by Social Cognitive Theory (SCT) and the Information-Motivation-Behavioral Skills (IMB) model. Objective This study aims to present the design and development process of “Gebelikte Kilo Yönetimi” (Gestational Weight Management), a user-centered, evidence-based mHealth application intended to promote healthy nutrition, physical activity, and GWG in line with the Institute of Medicine (IOM) recommendations. Methods A two-phase, parallel-group, single-blind randomized controlled trial was designed. In Phase 1, the mobile application was developed to support healthy GWG. In Phase 2, its effectiveness in improving adherence to IOM guidelines, promoting healthy eating, and increasing physical activity among pregnant women will be evaluated. The study is registered on ClinicalTrials.gov (NCT06542679). Conclusions This mHealth application may offer a scalable, accessible alternative to traditional face-to-face counseling, particularly in settings with limited healthcare access or during public health crises. It holds potential to improve GWG outcomes and support maternal health through digital innovation.