RecruitingNot ApplicableNCT04198857

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


Sponsor

Rutgers, The State University of New Jersey

Enrollment

220 participants

Start Date

Oct 18, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • receive antenatal care at Dhulikhel Hospital
  • receive a GDM diagnosis based on Carpenter-Coustan criteria or fail the Glucose Challenge Test only
  • less than 30 gestational weeks into pregnancy
  • own a smartphone
  • have internet connectivity at home
  • can understand and read Nepali

Exclusion Criteria1

  • • Patients with learning difficulties or vision/hearing impairments

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Interventions

BEHAVIORALDevelop 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.


Locations(1)

Dhulikhel Hospital, Kathmandu University Hospital

Dhulikhel, Kavrepalanchok, Nepal

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NCT04198857


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