Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) is a clinical and pathological syndrome characterized primarily by excessive intracellular fat accumulation in the liver, excluding alcohol-related and other specific causes. Recent research has identified an association between MASLD and an increased risk of pregnancy-related complications and adverse pregnancy outcomes, including gestational diabetes, preeclampsia, preterm birth, and large-for-gestational-age infants. MASLD in pregnant women poses multiple risks to maternal and infant health. Regular physical exercise during pregnancy has been shown to effectively reduce the incidence of pregnancy complications and adverse outcomes, while also alleviating hepatic steatosis and fibrosis. This study is a randomized controlled trial aimed at exploring the feasibility and effectiveness of online exercise interventions for pregnant women with MASLD, as well as conducting a cost-effectiveness analysis and investigating the underlying physiological mechanisms based on the liver-gut axis. The findings are intended to provide scientific evidence and practical recommendations for managing pregnancy health and intervening in MASLD during pregnancy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
220
Participants try to achieve 150 minutes of moderate-vigorous training per week. The exercise program includes live streaming exercise by trained health professionals, including pregnancy-specific exercises, with professional pregnancy trainers to provide guidance and support when needed.
Liver steatosis
LiSA, by Hepatus, Mindray, China；
Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
Liver stiffness measurement
E, by Hepatus, Mindray, China
Time frame: Changes from the 14th week to 36 weeks +6 days of pregnancy
Gestational weight change
weight changes in kilograms
Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
Incidence of pregnancy-related complications including gestational diabetes mellitus, gestational hypertension and related diseases
All diagnoses according to the guidelines.
Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
Changes in fasting serum lipids(TG, TC, LDL, HDL)
All data with the routine health check-up.
Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
Changes in fasting blood glucose
with the routine check-up
Time frame: Changes from the 14th week to 36 weeks +6 days of pregnancy
Changes in blood pressure
Both systolic and diastolic blood pressure are measured
Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
Changes in alanine aminotransferase (ALT)
Time frame: Changes from the 14th week to 36 weeks +6 days of pregnancy
Changes in aspartate aminotransferase (AST)
Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
Maternal physical activity
physical activity, which collected by International Physical Activity Questionnaire Short Form，IPAQ-SF
Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
Maternal sleep quality
sleep quality, which collected by Pittsburgh Sleep Quality Questionnaire
Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
Maternal mental health
mental health, which collected by Generalized Anxiety Disorder-7 questionnaire， Edinburgh Pregnancy Depression Scale and Patient Health Questionnaire-9 items
Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
Fetal height and weight
fetal height and weight, measured by ultrasonic, height in cm and weight in kg
Time frame: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.
Height and weight at birth
height, weight at birth,height measured with a rangefinder and weight measured with a scale,height in cm and weight in kg
Time frame: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.
Baby's Apgar Score
Apgar score，measured by clinical diagnosis
Time frame: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.
Preterm birth
preterm birth,clinical diagnosis
Time frame: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.
Small gestational week
small gestational week,clinical diagnosis
Time frame: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.
Large gestational week
large gestational week,clinical diagnosis
Time frame: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.
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