Live‐Streamed Exercise Intervention in Pregnant Women With MASLD (Live‐MASLD): Protocol for a Randomized Controlled Trial

In women of reproductive age, metabolic dysfunction-associated steatotic liver disease (MASLD) is associated with increased risks of gestational complications and adverse pregnancy outcomes. In addition, gestational MASLD may affect the lifelong health trajectory of the offspring. The live-streamed exercise intervention in pregnant women with metabolic dysfunction-associated steatotic liver disease (Live-MASLD) trial aims to investigate the efficacy of a live-streamed exercise intervention in ameliorating MASLD progression and improving maternal-infant health outcomes. A two-arm randomized controlled trial will be conducted across two centers. Pregnant individuals with MASLD in their first trimester will be recruited and randomly allocated to a control group or an intervention group. The control group will receive routine prenatal healthcare, while the intervention group will undergo a supervised, live-streamed exercise program during the second and third trimesters. Assessments will occur at baseline, second trimester, third trimester, delivery, and 42 days postpartum. Process evaluation will be conducted to allow for a health economic evaluation of the intervention. The primary outcome will describe between-group differences in changes to the hepatic steatosis index (LiSA) as quantitatively measured by visual transient elastography (ViTE). The findings from the Live-MASLD study will provide scientific evidence and implementation guidance for the clinical management of pregnant women with MASLD.