The prevalence of gestational diabetes mellitus (GDM) is rapidly increasing worldwide, particularly in low- and middle-income countries (LMICs). Tight glycemic control via diet and lifestyle modification is critical to treating GDM and preventing its adverse health consequences, including increased risk of type 2 diabetes (T2D), in women and their children. However, in many resource-limited countries including Nepal, time for diet/lifestyle counseling often competes with other components of antenatal care. Mobile health (mHealth) technology can be leveraged to promote healthy behaviors, and support self-management and treatment of GDM, but this approach has not been tried previously in any LMICs. Taking a user-centered design approach, here we propose to develop a culturally- appropriate smartphone application (app) to support self-management of GDM (mGDM), and test its usability and preliminary efficacy, among patients in a tertiary level, university hospital of Kathmandu University, Nepal. Based on the Social Cognitive Theory framework for behavior change, this app will assist in self-management of GDM by increasing the patient's knowledge and self-efficacy to adhere to the recommended diet and physical activity regimens. The app will also help clinicians by generating easily digestible visual displays of patient data and behaviors, which can aid in their clinical decision-making and counseling. In the requirements gathering phase, 6 GDM patients will be recruited into a focus group to view paper prototypes and provide feedback on its features and functions. Additional questions will be asked about their perceived barriers, facilitators, and strategies for lifestyle modification. Key informant interviews will also be conducted with 5 clinicians (gynecologists, dietician, physical therapist) and 3 family members, asking them to provide feedback on the mGDM prototype, especially pertaining to the usefulness and format of the graphic summaries of patient data. After revising paper prototypes and developing the first digital prototype, six additional patients with GDM will be recruited for two rounds of usability testing including think-aloud protocol and focus group discussions. Final prototype will be developed following an iterative process of product design and user testing. After developing the app, we will recruit 60 women who are newly diagnosed with GDM, and randomly assign them to one of two treatment conditions: either (A) mGDM app + standard care, or (B) standard care alone, from 28 weeks of gestation to 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 glycemic control measures at 6 weeks postpartum, neonatal birthweight, and rates of labor induction and caesarean delivery. Findings from the proposed study will empirically inform a future randomized control trial that will be fully powered to test the efficacy and cost-effectiveness of the mGDM app in improving treatment outcomes, using an R01 mechanism. We expect that the research activities and capacity building initiatives proposed in this application will build the institutional skills and create the organizational structure needed to enable future mHealth research initiatives at Kathmandu University, even beyond the scope of this proposed project.
(Public Health Relevance Statement): Adequate control and management of gestational diabetes mellitus (GDM) during pregnancy is critical to mitigate its short- and long-term health consequences in women and their children, and may serve as a key strategy to curb the escalating type 2 diabetes epidemic in low and middle income countries (LMICs). Taking a user-centered design approach, here we propose to develop a culturally-appropriate smartphone application (app) to support self-management of GDM, and additionally, test its usability and preliminary efficacy, among patients in a sub-urban hospital setting in Nepal. App-based lifestyle interventions for GDM management are not common, especially in LMICs where its prevalence is rapidly increasing, and as such, our study findings will have important public health relevance for a broader population.