JMIR Publications

ABSTRACT

Background:

The prevalence of gestational diabetes mellitus (GDM) is increasing, particularly in low- and middle-income countries (LMICs), such as Nepal. GDM self-management, including intensive diet/lifestyle modifications and blood glucose monitoring, is critical to maintain glycemic control and prevent adverse maternal and child outcomes. However, GDM self-management in resource-limited settings is challenging, as there are multiple barriers to engaging in optimal self-management behaviors. Mobile health (mHealth) technology is a potential 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-DH app, Phase 1) and test its usability and preliminary efficacy (Phase 2) among patients with GDM in a peri-urban hospital setting in Nepal.

Methods:

The study will be conducted at Dhulikhel Hospital, a flagship university hospital in Dhulikhel, Nepal. In the development phase (Phase 1), a prototype of the GDM-DH app, illustrating the app’s proposed interface, navigation sequences, and features and function, will be developed based on expert review 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), healthcare providers (n=5), and family members of patients with GDM (n=3), with plan to recruit further if saturation is not achieved. Incorporating their input, we will build a minimum viable product (MVP), which will be user-tested using a think-aloud protocol with 18 patients with GDM. 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 clinical trial (RCT) 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 to 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 measures at 6 weeks postpartum, neonatal birthweight, and rates of labor induction and cesarean delivery.

Results:

As of March 2024, we have completed the Phase 1 of the study, and enrollment for the RCT is currently underway. We expect the study to be completed 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 gather important information about leveraging the mHealth app-based platform for GDM self-management in LMICs. Clinical Trial: ClinicalTrials.gov NCT04198857