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

June 25, 2025 updated by: Haitian Chen, First Affiliated Hospital, Sun Yat-Sen University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3430

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The First Affiliated Hospital, Sun Yatsen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Composite neonatal outcome of large-gestational age and preterm birth
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Pregnancy-related hypertensive disorders
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Gestational diabetes mellitus
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Gestational hypertension
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Preeclampsia
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Eclampsia
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
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
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
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
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
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
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Mode of birth
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Primary caesarean
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
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
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
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
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Neonatal birthweight
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
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
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
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
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Neonatal hypoglycaemia
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
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
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
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
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
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
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Termination of pregnancy
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Neonatal death
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
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
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
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
Time Frame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital, Sun Yat-Sen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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