Early lifestyle program for pregnant women with mildly high early-pregnancy blood sugar
Effectiveness of a Lifestyle Intervention for Pregnant Women With Abnormal Glucose Metabolism in Early Pregnancy: EAGM Randomized Controlled Trial
This program tests whether starting diet, exercise, weight management and home blood‑glucose monitoring early in pregnancy helps women with mildly high early-pregnancy blood sugar have fewer large babies and preterm births.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3430 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06767722 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, open‑label, randomized, parallel‑group trial enrolling women before 14 weeks with fasting plasma glucose 5.1–6.9 mmol/L and/or HbA1c 5.7–6.4%. Participants are randomized 1:1 to an early lifestyle intervention (diet, exercise, weight management, structured education, self‑monitoring of blood glucose with professional feedback and insulin if indicated) or to routine prenatal care. The intervention includes an initial education session plus five follow‑up contacts delivered face‑to‑face during prenatal visits or by phone, and both groups receive a 24–28 week OGTT with treatment decisions based on results. The primary outcome is a composite of neonatal outcomes including large‑for‑gestational‑age infants and preterm birth.
Who should consider this trial
Good fit: Pregnant women aged 18 or older with a singleton viable pregnancy before 14 weeks and early abnormal glucose metabolism (FPG 5.1–6.9 mmol/L and/or HbA1c 5.7–6.4%) are the intended participants.
Not a fit: Women with pregestational diabetes (FPG ≥7.0 mmol/L or HbA1c ≥6.5%), multiple pregnancies, planned termination, use of glucose‑altering medications, or serious medical or psychological conditions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the approach could lower rates of large‑for‑gestational‑age infants and preterm births among women with early abnormal glucose metabolism.
How similar studies have performed: Lifestyle counseling and self‑monitoring have shown benefit in managing gestational diabetes, but evidence is limited for starting such interventions very early in pregnancy for mild abnormal glucose metabolism.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- The First Affiliated Hospital, Sun Yatsen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Haitian Chen, Professor
- Email: chhait@mail.sysu.edu.cn
- Phone: +8613763332296
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.