Effectiveness of a Lifestyle Intervention for Pregnant Women With Abnormal Glucose Metabolism in Early Pregnancy: EAGM Trial

This is a multicentre, parallel-group, open-label, pragmatic, randomised-control trial of early lifestyle intervention versus routine prenatal care by random allocation (1:1) in women with early abnormal glucose metabolism (EAGM) to compare the incidence of large-gestational age and preterm birth between two groups. The investigators aim to assess the effectiveness of early lifestyle interventions and to provide evidence for the optimal standard management for Chinese women with EAGM.

NCT Number	NCT06767722
Lead Sponsor	First Affiliated Hospital, Sun Yat-Sen University Collaborators: First People's Hospital of Foshan, Jiangmen Maternity and Child Health Care Hospital, Panyu Maternal And Child Care Service Centre Of Guangzhou, The Affiliated Shunde Hospital of Jinan University, Shenzhen Second People's Hospital, BoAi Hospital of Zhongshan, Yuebei People's Hospital, Qingyuan People's Hospital, The Sixth Affliated Hospital of Jinan University, Baoan Maternal And Child Health Care Hospital, Shenzhen, China, Jiangxi Maternal and Child Health Hospital, Guangxi provincial maternal and chidren's hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Women's Hospital School Of Medicine Zhejiang University, Xiangya Hospital of Central South University, Guangzhou Women's and Children's Hospital
Conditions	Early Pregnancy, Fasting Plasma Glucose, Hemoglobin A1c Protein, Human, Lifestyle Intervention, Adverse Pregnancy Outcomes
Enrollment	3,430 participants
Start Date	2025-04-16
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-07-01