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

Development and Testing of a Mobile App for Managing Gestational Diabetes in Nepal

Background

Gestational diabetes mellitus (GDM) is becoming more common, especially in countries like Nepal. Managing GDM is essential to keep blood sugar levels in check and avoid complications. However, many people face challenges in managing their condition due to limited resources. Mobile health (mHealth) technology can help improve GDM treatment by encouraging healthy habits and self-management, but it hasn’t been tested in low- and middle-income countries yet.

Objective

This study aims to create a culturally appropriate mHealth app (GDM-Dhulikhel Hospital app) to assist patients in managing their GDM. The app will be developed and tested for usability and effectiveness in a hospital in Nepal.

Methods

The study will take place at Dhulikhel Hospital in Nepal. In the first phase, we will create a prototype of the GDM-DH app based on expert opinions and user feedback. We will conduct focus groups and interviews with GDM patients, healthcare providers, and family members to identify challenges and gather suggestions. This feedback will help us refine the app, which will then be tested by 18 patients using a think-aloud method.

In the second phase, we will recruit 120 newly diagnosed GDM patients and randomly assign them to receive either standard care or standard care plus the GDM-DH app from 24-30 weeks of pregnancy until delivery. We will evaluate how well the app is used, how patients monitor their health, and how they feel about the app. We will also look at health outcomes like blood sugar control, birth weight, and delivery methods.

Results

As of July 2024, we have completed the first phase and are currently in the second phase. We enrolled our first participant in October 2021 and have 99 participants as of July 2024. We expect to finish recruitment by December 2024 and share our findings by December 2025.

Conclusions

Using app-based interventions for managing GDM is rare in low- and middle-income countries, despite the rising prevalence of GDM. This trial will provide important insights into how mHealth apps can support GDM self-management in these regions.

Trial Registration

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

Additional Information

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