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.
Pregnant women in early pregnancy (within 13 weeks and 6 days of gestation)
Planned delivery at a participating study hospital
Age 18 years or older
Singleton pregnancy
• Pre-pregnancy diabetes mellitus or overt diabetes diagnosed at the first antenatal visit (fasting blood glucose greater than or equal to 7.0 mmol/L)
Pre-existing hypertension, autoimmune disease, major infection, or severe liver or kidney disease
Use of medications that affect glucose metabolism, such as corticosteroids or metformin
Severe psychiatric disorders
Parallel
Digital Health Lifestyle Intervention
BehavioralParticipants 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.
Incidence of Gestational Diabetes Mellitus
Gestational diabetes mellitus diagnosed during pregnancy according to routine oral glucose tolerance testing and the IADPSG/WHO diagnostic criteria used at participating hospitals.
Gestational Weight Gain
Total gestational weight gain during pregnancy based on routine antenatal records.
Cesarean Delivery
Mode of delivery recorded from hospital medical records.
Macrosomia
Occurrence of macrosomia recorded in delivery records.
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Peking University
Lead sponsor
National Natural Science Foundation of China
Collaborator
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