Actively Recruiting
Effectiveness of a Lifestyle Intervention for Pregnant Women With Abnormal Glucose Metabolism in Early Pregnancy: EAGM Randomized Controlled Trial
Led by First Affiliated Hospital, Sun Yat-Sen University · Updated on 2025-07-01
3430
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
F
First Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor
F
First People's Hospital of Foshan
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of an early lifestyle intervention compared to routine prenatal care in pregnant women with early abnormal glucose metabolism (EAGM). This study aims to reduce the incidence of large-for-gestational-age babies and preterm birth. The trial focuses on Chinese women diagnosed with abnormal glucose levels before 14 weeks of pregnancy, assessing the best standard management approach in this population. Participants will be randomly assigned to one of two groups. The intervention group will receive lifestyle advice on diet, exercise, weight control, and self-monitoring of blood glucose, with feedback from healthcare providers and insulin treatment if needed. This is delivered through an initial educational session followed by five follow-ups approximately every four months, either in-person during prenatal visits or by phone. Both groups receive routine prenatal care, but the control group does not get the lifestyle intervention. An oral glucose tolerance test (OGTT) is performed at 24-28 weeks, with intervention continuing for those diagnosed with gestational diabetes or diabetes until delivery. Throughout the study, researchers will monitor outcomes related to the baby's size and birth timing up to hospital discharge or 28 days after the expected delivery date. Secondary outcomes include conditions like pregnancy-related hypertension, gestational diabetes, birth mode, and neonatal health indicators. Participants will undergo regular assessments during prenatal visits, and blood glucose is closely tracked. The total study duration covers pregnancy until shortly after birth, providing comprehensive monitoring of maternal and neonatal health.
CONDITIONS
Brief Title
Effectiveness of a Lifestyle Intervention for Pregnant Women With Abnormal Glucose Metabolism in Early Pregnancy: EAGM Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years of age and under 56 years
- Able to provide informed consent
- Confirmed viable singleton pregnancy by nuchal translucency scan between 11+0 and 13+6 weeks
- Abnormal glucose metabolism before 14 weeks, defined as fasting plasma glucose 5.1-6.9 mmol/L and/or hemoglobin A1c 5.7%-6.4%
You will not qualify if you...
- Diagnosed pregestational diabetes or impaired glucose tolerance before pregnancy
- Plan to terminate pregnancy due to fetal anomaly found in the first trimester scan
- Use of medications that affect glucose metabolism (e.g., corticosteroids, antipsychotic drugs) at randomization
- Serious physical conditions such as cancer, organ failure, epilepsy, paraplegia, or disability
- Serious psychological conditions including learning difficulties or serious mental illness
- Current hyperemesis gravidarum causing dehydration or requiring hospitalization unless resolved before 14+6 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 14 weeks of gestation
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - From enrollment until delivery
Participants in the intervention group receive lifestyle advice on diet, exercise, weight management, and self-monitoring of blood glucose with feedback from healthcare professionals. The initial educational session is followed by five follow-up sessions approximately every four weeks, conducted either face-to-face during routine prenatal visits or via telephone consultation. Participants in the control group receive routine prenatal care only.
Initial session plus 5 follow-up sessions approximately every four weeks
Duration - 24 to 28 weeks of gestation
All participants receive an oral glucose tolerance test (OGTT) at 24-28 weeks of gestation unless insulin treatment is initiated earlier due to suboptimal blood glucose control. Depending on OGTT results, participants diagnosed with gestational diabetes or overt diabetes continue the intervention plus routine prenatal care until delivery, while those with normal results pause the intervention and follow routine prenatal care only.
1 visit for OGTT test
Duration - Until delivery
Participants are observed with routine prenatal care until delivery. Those continuing intervention plus routine prenatal care receive ongoing assessments as part of prenatal visits.
Routine prenatal visits until delivery
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Sun Yatsen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
H
Haitian Chen, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here