NCT07499622

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Dec 2028

First Submitted

Initial submission to the registry

March 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 24, 2026

Last Update Submit

March 24, 2026

Conditions

Gestational Diabetes Mellitus (GDM)

Outcome Measures

Primary Outcomes (1)

  • 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.

    At 24 to 28 weeks of gestation

Secondary Outcomes (3)

  • Gestational Weight Gain

    From enrollment to delivery

  • Cesarean Delivery

    At delivery

  • Macrosomia

    At delivery

Study Arms (2)

Digital Health Intervention

EXPERIMENTAL

Participants in this arm will receive a digital health intervention in addition to routine antenatal care. The intervention includes online health education, individualized lifestyle guidance, self-management tools, health information delivery, and interactive consultation through a digital platform. The intervention focuses on gestational weight management, diet, physical activity, sleep, and prevention of gestational diabetes mellitus.

Behavioral: Digital Health Lifestyle Intervention

Usual Care

NO INTERVENTION

Participants in this arm will receive routine antenatal care and standard pregnancy health education provided by the hospital, without additional digital health intervention.

Interventions

Digital Health Lifestyle InterventionBEHAVIORAL

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.

Digital Health Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Identified as high risk for gestational diabetes mellitus by the study risk assessment model
  • Willing and able to provide informed consent

You may not qualify if:

  • 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
  • Inability or unwillingness to comply with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Tongzhou Maternal and Child Health Hospital

Beijing, Beijing Municipality, 10010, China

Location

Weifang Maternal and Child Health Hospital

Weifang, Shandong, 261042, China

Location

Related Publications (2)

  • Artzi NS, Shilo S, Hadar E, Rossman H, Barbash-Hazan S, Ben-Haroush A, Balicer RD, Feldman B, Wiznitzer A, Segal E. Prediction of gestational diabetes based on nationwide electronic health records. Nat Med. 2020 Jan;26(1):71-76. doi: 10.1038/s41591-019-0724-8. Epub 2020 Jan 13.

    PMID: 31932807RESULT

  • Allotey J, Coomar D, Ensor J, Ruiz-Calvo G, Boath A, Ogwulu CO, Monahan M, Kabeya V, Zheng M, McNeill R, Meacham H, Mahmoud G, Simpson SA, Hitman GA, Nirantharakumar K, Heslehurst N, Pelaez M, Tonstad S, Yeo S, Cecatti JG, Facchinetti F, Motahari-Tabari NS, Renault KM, Guelfi KJ, Jensen DM, Harrison C, Khomami MB, Calle-Pascual AL, McAuliffe FM, Hauner H, Barakat R, Geiker NRW, Vinter CA, Phelan S, Kinnunen TI, Kothari A, Teede H, Poston L, Betran AP, Moss N, Iliodromiti S, Austin F, Roberts T, Zamora J, Riley RD, Thangaratinam S; i-WIP Collaborative Group. Effects of lifestyle interventions in pregnancy on gestational diabetes: individual participant data and network meta-analysis. BMJ. 2026 Jan 6;392:e084159. doi: 10.1136/bmj-2025-084159.

    PMID: 41494781RESULT

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Jue Liu, PhD

CONTACT

+86 13426455743jueliu@bjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the digital health and lifestyle intervention, participants and study personnel are not masked to group assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants identified as high risk for gestational diabetes mellitus in early pregnancy will be randomly assigned in a 1:1 ratio to either a digital health intervention group or a usual care group and followed through pregnancy and delivery.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2026

First Posted

March 30, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made publicly available because the study involves sensitive personal and health information from pregnant women, and data sharing is restricted by ethical approval, informed consent, and institutional data protection policies.

Locations

CN(2)