Development and Testing of a Mobile Health Application for Management of Gestational Diabetes

NCT04198857 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-09-17

No results posted yet for this study

Summary

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 the study investigators 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 peri-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, study findings will have important public health relevance for a broader population.

Conditions

  • Diabetes, Gestational
  • Telemedicine

Interventions

BEHAVIORAL

Develop a mobile app that supports self- management and treatment for Nepalese GDM patients

We will use a user-centered design approach to develop a mobile app for GDM (GDM-DH) that matches the needs and technological sophistication of the target users. The goal of the app would be to assist patients in self management of GDM by improving their adherence to the recommended diet and physical activity regimens. The app will be used to collect information such as the carbohydrate consumption, the daily activity status and blood glucose and blood pressure measurements taken at home by the patients. The app will be set up in the phone of the participants and their data will be collected. The participants will be able to assess the usability and feasibility of the app. 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.

Sponsors & Collaborators

  • Nepal Health Research Council

    collaborator OTHER_GOV
  • University of Connecticut

    collaborator OTHER
  • Fogarty International Center of the National Institute of Health

    collaborator NIH
  • Dhulikhel Hospital

    collaborator OTHER
  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Shristi Rawal, PhD · Rutgers University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-18
Primary Completion
2026-04-30
Completion
2026-12-18

Countries

  • Nepal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04198857 on ClinicalTrials.gov