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

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

Study Overview

• Status: Recruiting
• Conditions: Lifestyle Intervention; Early Pregnancy; Adverse Pregnancy Outcomes; Fasting Plasma Glucose; Hemoglobin A1c Protein, Human
• Intervention / Treatment: Behavioral: Lifestyle intervention and self-monitoring of blood glucose

Detailed Description

Women with early abnormal glucose metabolism (EAGM) , which is defined as fasting plasma glucose (FPG) 5.1-6.9 mmol/L and/or hemoglobin A1c (HbA1c) 5.7%-6.4% at before 14 weeks of gestation, will be recruited and randomized in a 1:1 ratio into the intervention or control group. 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. The educational session is delivered as an initial session following randomization followed by five follow-up sessions which will occur approximately every four months, either face-to-face during routine prenatal visits or via telephone consultation. Routine prenatal care will also be applied to the intervention group. Women in the control group will only receive routine prenatal care. Both groups will receive an OGTT test at 24-28 weeks of gestation unless insulin is needed before the OGTT test for suboptimally controlled blood glucose levels. Whether to continue the intervention depends on the OGTT results as women diagnosed with GDM or overt diabetes will continue intervention plus routine prenatal care until delivery while those will normal OGTT result will pause interventions and follow the routine prenatal care only until delivery. The primary outcome of our trial will be a composite of neonatal outcome including large-for-gestational age and preterm birth.

• Study Type: Interventional
• Enrollment (Estimated): 3430
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haitian Chen, Professor; Phone Number: +8613763332296; Email: chhait@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • The First Affiliated Hospital, Sun Yatsen University
      • Contact: Lingyi Kong, Postdoc; Phone Number: 86-15521232009; Email: Kongly9@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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%.

Exclusion Criteria:

• 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.
• Women currently with hyperemesis gravidarum leading to dehydration or requiring hospitalization. If persisting vomiting resolves, the patient may be reassessed for inclusion in the trial up to and including 14+6 weeks of gestation, providing all other inclusion and exclusion criteria are met.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; The Intervention group will receive both intervention and routine prenatal care.	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.
No Intervention: control group; The control group will only receive routine prenatal care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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.
Prescription of hypoglycaemic drug	outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Preeclampsia requiring delivery before 37 weeks	outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Total gestational weight gain	outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Mode of birth	outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Primary caesarean	outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Large-for-gestational age	outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Preterm birth at <37 weeks of gestation	outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Neonatal birthweight	outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Small-for-gestational-age	outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Gestational age at birth, weeks and days	outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Neonatal hypoglycaemia	outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Admission to neonatal wards or intensive care unit	outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Fetal loss <24 weeks of gestation	outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Fetal loss ≥24 weeks of gestation	outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Termination of pregnancy	outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Neonatal death	outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Apgar score at 1min after birth	outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Apgar score at 5min after birth	outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: January 5, 2025
• First Submitted That Met QC Criteria: January 5, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: [2024]645

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No