Early PregnancyEAGMNCT06767722
Effectiveness of a Lifestyle Intervention for Pregnant Women With Abnormal Glucose Metabolism in Early Pregnancy: EAGM Trial
A study testing Lifestyle intervention and self-monitoring of blood glucose in people with Early Pregnancy and Fasting Plasma Glucose, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Early Pregnancy, Fasting Plasma Glucose, Hemoglobin A1c Protein, Human
- What is being tested?
- Lifestyle intervention and self-monitoring of blood glucose
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,430 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Sun Yatsen University
Guangzhou, Guangdong, 510000
Lingyi Kong, Postdoc, 86-15521232009, Kongly9@mail.sysu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Early Pregnancy, Fasting Plasma Glucose, Hemoglobin A1c Protein, Human, Lifestyle Intervention, Adverse Pregnancy Outcomes
- Being tested
- Lifestyle intervention and self-monitoring of blood glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle intervention and self-monitoring of blood glucoseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The Intervention group will receive both intervention and routine prenatal care. Receives: Behavioral: Lifestyle intervention and self-monitoring of blood glucose |
| control group | No intervention | The control group will only receive routine prenatal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite neonatal outcome of large-gestational age and preterm birth
Measured: 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
Measured: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Gestational diabetes mellitus
Measured: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Gestational hypertension
Measured: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Preeclampsia
Measured: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Eclampsia
Measured: 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
Measured: 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
Measured: 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
Measured: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Mode of birth
Measured: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Primary caesarean
Measured: 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
Measured: 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
Measured: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Neonatal birthweight
Measured: 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
Measured: 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
Measured: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Neonatal hypoglycaemia
Measured: 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
Measured: 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
Measured: 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
Measured: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Termination of pregnancy
Measured: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Neonatal death
Measured: 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
Measured: 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
Measured: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start16 Apr 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early PregnancyStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,430 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Haitian Chen, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767722
- Sponsor's protocol ID
- [2024]645
- Acronym
- EAGM
- Status last verified
- Apr 2025
- First submitted
- 5 Jan 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kong L, Shen L, Xie L, Li Z, Zhu C, Zhang S, Huang Y, Wang Z, Chen H. Effectiveness of a lifestyle intervention for pregnant women with abnormal glucose metabolism in early pregnancy (EAGM): protocol for a multicentre, open-labelled, two-arm, pragmatic randomised controlled trial. BMC Pregnancy Childbirth. 2026 Mar 9;26(1):410. doi: 10.1186/s12884-026-08908-6.
PubMed 41796294
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Lifestyle Intervention for Pregnant Women With Abnormal Glucose Metabolism in Early Pregnancy: EAGM Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06767722
- Acronym / sponsor ID
- EAGM / [2024]645
- Conditions
- Early Pregnancy, Fasting Plasma Glucose, Hemoglobin A1c Protein, Human, Lifestyle Intervention, Adverse Pregnancy Outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,430 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- 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
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Lifestyle intervention and self-monitoring of blood glucoseThe Intervention group will receive both intervention and routine prenatal care. |
| control group | No intervention | –The control group will only receive routine prenatal care. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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%.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle intervention and self-monitoring of blood glucoseThe 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. | Behavioural | intervention group |
Primary outcome
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.
23 secondary outcomes
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.
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.
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.
Preeclampsia
Time frame: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Derived from this study: PubMed 41796294Kong L, Shen L, Xie L, Li Z, Zhu C, Zhang S, Huang Y, Wang Z, Chen H. Effectiveness of a lifestyle intervention for pregnant women with abnormal glucose metabolism in early pregnancy (EAGM): protocol for a multicentre, open-labelled, two-arm, pragmatic randomised controlled trial. BMC Pregnancy Childbirth. 2026 Mar 9;26(1):410. doi: 10.1186/s12884-026-08908-6.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention and self-monitoring of blood glucose in people with Early Pregnancy and Fasting Plasma Glucose, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haitian Chen, Professor (+8613763332296, chhait@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06767722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.