RecruitingNot ApplicableNCT06767722

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

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

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Enrollment

3,430 participants

Start Date

Apr 16, 2025

Study Type

INTERVENTIONAL

Conditions

Lifestyle Intervention Early Pregnancy Adverse Pregnancy Outcomes Fasting Plasma Glucose Hemoglobin A1c Protein, Human

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. 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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Lifestyle intervention and self-monitoring of blood glucose for people with adverse pregnancy outcomes, early pregnancy, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALLifestyle 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.