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| Name | Class |
|---|---|
| Beijing Friendship Hospital | OTHER |
| W.F. Maternal and Child Health Hospital | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Live Streaming Exercise | Experimental | Live Streaming Exercise:Conduct supervised exercise guidance interventions from the 14th week of pregnancy and continuing through the 36+6th week. |
|
| Regular care | No Intervention | Regular care:health education. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live Streaming Exercise | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Liver steatosis | LiSA, by Hepatus, Mindray, Chinaï¼› | Changes from the 14th week to 36 weeks + 6 days of pregnancy |
| Liver stiffness measurement | E, by Hepatus, Mindray, China | Changes from the 14th week to 36 weeks +6 days of pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational weight change | weight changes in kilograms | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Wang, Ph.D | Contact | 19800363805 | huiwang@bjmu.edu.cn | |
| Mingyue Wang, MD | Contact | 19862183196 | 2311110212@stu.pku.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hui Wang, Ph.D | Peking University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36626630 | Background | Younossi ZM, Golabi P, Paik JM, Henry A, Van Dongen C, Henry L. The global epidemiology of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH): a systematic review. Hepatology. 2023 Apr 1;77(4):1335-1347. doi: 10.1097/HEP.0000000000000004. Epub 2023 Jan 3. | |
| 31070259 | Background |
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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.
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All diagnoses according to the guidelines.
| 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. | Changes from the 14th week to 36 weeks + 6 days of pregnancy |
| Changes in fasting blood glucose | with the routine check-up | Changes from the 14th week to 36 weeks +6 days of pregnancy |
| Changes in blood pressure | Both systolic and diastolic blood pressure are measured | Changes from the 14th week to 36 weeks + 6 days of pregnancy |
| 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 | physical activity, which collected by International Physical Activity Questionnaire Short Form,IPAQ-SF | Changes from the 14th week to 36 weeks + 6 days of pregnancy |
| Maternal sleep quality | sleep quality, which collected by Pittsburgh Sleep Quality Questionnaire | 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 | 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 | 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 | 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 | 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 | 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 | 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 | fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery. |
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