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

Summary

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.

Conditions

• Early Pregnancy
• Fasting Plasma Glucose
• Hemoglobin A1c Protein, Human
• Lifestyle Intervention
• Adverse Pregnancy Outcomes

Interventions

BEHAVIORAL

Lifestyle intervention and self-monitoring of blood glucose

The intervention will consist of a lifestyle intervention that comprises advice on diet, exercise, weight management, and self-monitoring of blood glucose (SMBG) with feedback from healthcare professionals on results and insulin treatment if indicated.

Sponsors & Collaborators

• First People's Hospital of Foshan

  collaborator OTHER

• Jiangmen Maternity and Child Health Care Hospital

  collaborator UNKNOWN

• Panyu Maternal And Child Care Service Centre Of Guangzhou

  collaborator UNKNOWN

• The Affiliated Shunde Hospital of Jinan University

  collaborator UNKNOWN

• Shenzhen Second People's Hospital

  collaborator OTHER

• Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-sen University

  collaborator UNKNOWN

• BoAi Hospital of Zhongshan

  collaborator OTHER

• Yuebei People's Hospital

  collaborator OTHER

• Qingyuan People's Hospital

  collaborator OTHER

• The Sixth Affliated Hospital of Jinan University

  collaborator UNKNOWN

• Baoan Maternal And Child Health Care Hospital, Shenzhen, China

  collaborator UNKNOWN

• Jiangxi Maternal and Child Health Hospital

  collaborator OTHER

• Guangxi provincial maternal and chidren's hospital

  collaborator UNKNOWN

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Obstetrics and Gynecology Hospital of Zhejiang University

  collaborator UNKNOWN

• Xiangya Hospital of Central South University

  collaborator OTHER

• Guangzhou Women's and Children's Hospital

  collaborator UNKNOWN

• First Affiliated Hospital, Sun Yat-Sen University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-16

Primary Completion

2027-06-30

Completion

2027-06-30

Countries

• China

Study Locations