Prevention of gestational diabetes mellitus through intensive lifestyle intervention in high-risk pregnant individuals: a study protocol for an open-label multicenter randomized controlled trial

Pregnant women with established risk factors, such as a family history of diabetes, advanced maternal age, and prepregnancy obesity, have an increased likelihood of developing gestational diabetes mellitus (GDM). Whether individualized intensive lifestyle management initiated in early pregnancy can reduce the occurrence of GDM in this high-risk population remains uncertain. This trial is designed to investigate the effectiveness of such an intervention in preventing GDM. This investigator-initiated, multicenter, open-label, randomized controlled trial will recruit 346 pregnant women at high risk for GDM from three participating centers. Following written informed consent, participants will be allocated in a 1:1 ratio to either the intensive lifestyle intervention group or the control group. The primary endpoint is the diagnosis of GDM based on a 75-g oral glucose tolerance test performed between 24 and 28 weeks of gestation. Secondary endpoints include maternal and neonatal outcomes, maternal physical and psychological health, and body composition, all assessed through follow-up extending to six months after delivery. The study aims to compare an individualized intensive lifestyle intervention combined with continuous glucose monitoring (CGM) against standard prenatal care. We hypothesize that this intensive strategy will improve intervention adherence and thereby facilitate effective GDM prevention among high-risk pregnant women. ChiCTR2400091534. Registered on 30 October 2024.