MedTrace Logo

Digital Health Intervention for Early Identification and Prevention of Gestational Diabetes Mellitus

NCT07499622 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2026-03-30

No results posted yet for this study

Summary

This study aims to develop and evaluate an early risk identification and digital health intervention strategy for gestational diabetes mellitus (GDM) among pregnant women in China. Gestational diabetes mellitus is a common pregnancy complication associated with adverse maternal and neonatal outcomes, including excessive gestational weight gain, macrosomia, cesarean delivery, and increased long-term risk of metabolic disorders in both mothers and offspring.

The study includes two components. First, retrospective multi-source clinical data from maternal health records will be used to develop and validate a risk prediction model for early identification of pregnant women at high risk of GDM. Second, pregnant women identified as high risk in early pregnancy will be enrolled in a multicenter randomized controlled trial and assigned to either a digital health intervention group or a usual care group. The intervention includes online health education, individualized lifestyle guidance, behavioral self-management tools, and interactive consultation through a digital platform. The primary outcome is the incidence of GDM diagnosed during pregnancy. Secondary outcomes include gestational weight gain, cesarean delivery, macrosomia, and other maternal and neonatal outcomes.

This study is expected to provide evidence for improving early risk assessment, intelligent warning, and prevention strategies for GDM in the context of maternal health management in China.

Conditions

  • Gestational Diabetes Mellitus (GDM)

Interventions

BEHAVIORAL

Digital Health Lifestyle Intervention

Participants receive a digital health lifestyle intervention in addition to routine antenatal care. The intervention is delivered through a digital platform and includes online health education, individualized lifestyle guidance, self-management tools, health information delivery, and interactive consultation. The intervention focuses on gestational weight management, diet, physical activity, sleep, and early prevention of gestational diabetes mellitus among pregnant women identified as high risk.

Sponsors & Collaborators

  • National Natural Science Foundation of China

    collaborator OTHER_GOV

  • Peking University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-06-30
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

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 NCT07499622 on ClinicalTrials.gov