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

NCT06767722 | Recruiting DMC

• 1 other identifier: [2024]645
• Study Type: interventional
• Target: 3,430
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Composite neonatal outcome of large-gestational age and preterm birth

  outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.

Secondary Outcomes (23)

• Pregnancy-related hypertensive disorders

  outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.

• Gestational diabetes mellitus

  outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.

• Gestational hypertension

  outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.

• Preeclampsia

  outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.

• Eclampsia

  outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.

Study Arms (2)

intervention group

EXPERIMENTAL

The Intervention group will receive both intervention and routine prenatal care.

Behavioral: Lifestyle intervention and self-monitoring of blood glucose

control group

NO INTERVENTION

The control group will only receive routine prenatal care.

Interventions

Lifestyle intervention and self-monitoring of blood glucose BEHAVIORAL

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.

intervention group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Over 18 years of age.
• Able to provide informed consent.
• Confirmed viable pregnancy on a nuchal translucency scan done between 11+0 and 13+6 weeks.
• Singleton pregnancies.
• An abnormal glucose metabolism determined by a blood test performed before 14 weeks, defined as FPG 5.1-6.9mmol/L and/or HbA1c 5.7-6.4%.

You may not qualify if:

• Pregestational diabetes (diagnosed as diabetes mellitus before pregnancy, or FPG≥7.0mmol/L, or HbA1c≥6.5% at the first prenatal visit), impaired fasting glucose or impaired glucose tolerance diagnosed before pregnancy.
• Plan for termination of pregnancy due to fetal anomaly identified at the first trimester scan.
• Use of medications known to interfere with glucose metabolism (e.g. corticosteroids, antipsychotic drugs) at the time of randomisation.
• Any other physical (serious medical conditions such as cancer, organ failure, epilepsy, paraplegia, disability) or psychological condition (e.g. learning difficulties, serious mental illness) that is likely to interfere with the conduct of the trial according to evaluation by the trial monitoring group.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead
• First People's Hospital of Foshan: collaborator
• Jiangmen Maternity and Child Health Care Hospital: collaborator
• Panyu Maternal And Child Care Service Centre Of Guangzhou: collaborator
• The Affiliated Shunde Hospital of Jinan University: collaborator
• Shenzhen Second People's Hospital: collaborator
• Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-sen University: collaborator
• BoAi Hospital of Zhongshan: collaborator
• Yuebei People's Hospital: collaborator
• Qingyuan People's Hospital: collaborator
• The Sixth Affliated Hospital of Jinan University: collaborator
• Baoan Maternal And Child Health Care Hospital, Shenzhen, China: collaborator
• Jiangxi Maternal and Child Health Hospital: collaborator
• Guangxi provincial maternal and chidren's hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Obstetrics and Gynecology Hospital of Zhejiang University: collaborator
• Xiangya Hospital of Central South University: collaborator
• Guangzhou Women's and Children's Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital, Sun Yatsen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Interventions

Blood Glucose Self-Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Central Study Contacts

Haitian Chen, Professor

CONTACT

+8613763332296; chhait@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: January 10, 2025
• Study Start: April 16, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)