Development and Testing of a Mobile App for Management of Gestational Diabetes in Nepal: Protocol for a User-Centered Design Study and Exploratory Randomized Controlled Trial.

Background: The prevalence of gestational diabetes mellitus (GDM) is increasing, particularly in low- and middle-income countries (LMICs) like Nepal. GDM self-management, including intensive dietary and lifestyle modifications and blood glucose monitoring, is critical to maintain glycemic control and prevent adverse outcomes. However, in resource-limited settings, several barriers hinder optimal self-management. Mobile health (mHealth) technology holds promise as a strategy to augment GDM treatment by promoting healthy behaviors and supporting self-management, but this approach has not yet been tested in any LMIC.

Objective: This report describes the protocol to develop a culturally tailored mHealth app that supports self-management and treatment of GDM (GDM-Dhulikhel Hospital [GDM-DH] app, phase 1) and test its usability and preliminary efficacy (phase 2) among patients with GDM in a periurban hospital setting in Nepal.

Methods: The study will be conducted at Dhulikhel Hospital in Dhulikhel, Nepal. In the development phase (phase 1), a prototype of the GDM-DH app will be developed based on expert reviews and a user-centered design approach. To understand facilitators and barriers to GDM self-management and to gather feedback on the prototype, focus groups and in-depth interviews will be conducted with patients with GDM (n=12), health care providers (n=5), and family members (n=3), with plans to recruit further if saturation is not achieved. Feedback will be used to build a minimum viable product, which will undergo user testing with 18 patients with GDM using a think-aloud protocol. The final GDM-DH app will be developed based on user feedback and following an iterative product design and user testing process. In the randomized controlled trial phase (phase 2), newly diagnosed patients with GDM (n=120) will be recruited and randomized to either standard care alone or standard care plus the GDM-DH app from 24-30 weeks gestation until delivery. In this proof-of-concept trial, feasibility outcomes will be app usage, self-monitoring adherence, and app usability and acceptability. Exploratory treatment outcomes will be maternal glycemic control at 6 weeks post partum, birth weight, and rates of labor induction and cesarean delivery. Qualitative data obtained from phase 1 will be analyzed using thematic analysis. In phase 2, independent 2-tailed t tests or chi-square analyses will examine differences in outcomes between the 2 treatment conditions.

Results: As of July 2024, we have completed phase 1. Phase 2 is underway. The first participant was enrolled in October 2021, with 99 participants enrolled as of July 2024. We anticipate completing recruitment by December 2024 and disseminating findings by December 2025.

Conclusions: App-based lifestyle interventions for GDM management are not common in LMICs, where GDM prevalence is rapidly increasing. This proof-of-concept trial will provide valuable insights into the potential of leveraging mHealth app-based platforms for GDM self-management in LMICs.

Trial registration: ClinicalTrials.gov NCT04198857; https://clinicaltrials.gov/study/NCT04198857.

International registered report identifier (irrid): DERR1-10.2196/59423.