Metabolic Dysfunction-associated Steatotic Liver Disease
Conditions
Keywords
Randomized Controlled Trial, Live streaming exercise
Brief summary
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.
Interventions
BEHAVIORALLive Streaming Exercise
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.
Sponsors
Beijing Friendship Hospital
W.F. Maternal and Child Health Hospital
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
The study will randomize eligible MASLD pregnant women into two groups: a control group and an intervention group. The control group will receive standard prenatal care, while the intervention group will receive supervised exercise guidance starting from the 14th week of pregnancy and continuing through the 36+6th week. Quality control, data collection, and biological sample collection will be conducted throughout the intervention period.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Singleton pregnancy; 2. Gestational age ≤10-13+6 weeks at enrollment; 3. Age between 20 and 45 years; 4. Patients diagnosed with MASLD; 5. Signed informed consent.
Exclusion criteria
1. Cervical length ≤ 25 mm; 2. History of threatened abortion; 3. Exercise contraindications or doctor advice not to exercise during pregnancy; 4. Current or previous use of drugs that affect body weight (such as hormones); 5. Patients with chronic hepatitis virus or other chronic liver diseases, excluding MASLD; 6. Non-natural conception or infertility treatment; 7. Any previous medication for hypertension, diabetes, heart disease, kidney disease, systemic lupus erythematosus, thyroid disease or mental illness; 8. Participating in other pregnancy intervention research projects.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver steatosis | Changes from the 14th week to 36 weeks + 6 days of pregnancy | LiSA, by Hepatus, Mindray, China； |
| Liver stiffness measurement | Changes from the 14th week to 36 weeks +6 days of pregnancy | E, by Hepatus, Mindray, China |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in fasting serum lipids(TG, TC, LDL, HDL) | Changes from the 14th week to 36 weeks + 6 days of pregnancy | All data with the routine health check-up. |
| Changes in fasting blood glucose | Changes from the 14th week to 36 weeks +6 days of pregnancy | with the routine check-up |
| Changes in blood pressure | Changes from the 14th week to 36 weeks + 6 days of pregnancy | Both systolic and diastolic blood pressure are measured |
| Changes in alanine aminotransferase (ALT) | Changes from the 14th week to 36 weeks +6 days of pregnancy | — |
| Changes in aspartate aminotransferase (AST) | Changes from the 14th week to 36 weeks + 6 days of pregnancy | — |
| Maternal physical activity | Changes from the 14th week to 36 weeks + 6 days of pregnancy | physical activity, which collected by International Physical Activity Questionnaire Short Form，IPAQ-SF |
| Maternal sleep quality | Changes from the 14th week to 36 weeks + 6 days of pregnancy | sleep quality, which collected by Pittsburgh Sleep Quality Questionnaire |
| Gestational weight change | Changes from the 14th week to 36 weeks + 6 days of pregnancy | weight changes in kilograms |
| Fetal height and weight | fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery. | fetal height and weight, measured by ultrasonic, height in cm and weight in kg |
| Height and weight at birth | fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery. | height, weight at birth,height measured with a rangefinder and weight measured with a scale,height in cm and weight in kg |
| Baby's Apgar Score | fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery. | Apgar score，measured by clinical diagnosis |
| Preterm birth | fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery. | preterm birth,clinical diagnosis |
| Small gestational week | fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery. | small gestational week,clinical diagnosis |
| Large gestational week | fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery. | large gestational week,clinical diagnosis |
| Maternal mental health | Changes from the 14th week to 36 weeks + 6 days of pregnancy | mental health, which collected by Generalized Anxiety Disorder-7 questionnaire， Edinburgh Pregnancy Depression Scale and Patient Health Questionnaire-9 items |
| Incidence of pregnancy-related complications including gestational diabetes mellitus, gestational hypertension and related diseases | Changes from the 14th week to 36 weeks + 6 days of pregnancy | All diagnoses according to the guidelines. |
Contacts
Primary ContactHui Wang, Ph.D
Backup ContactMingyue Wang, MD
Outcome results
None listed