Metabolic Dysfunction-Associated Steatotic Liver DiseaseNCT06682663

Impact of Live Streaming Exercise on Liver Health in MASLD Pregnant Women

A study testing Live Streaming Exercise in people with Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Peking University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 45 years, women only
Conditions the study is for: Metabolic Dysfunction-Associated Steatotic Liver Disease
What is being tested?: Live Streaming Exercise
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 220 participants
Where: 1 siteChina
Study dates: 18 Nov 2024to 8 Aug 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

Singleton pregnancy;
Gestational age ≤10-13+6 weeks at enrollment;
Age between 20 and 45 years;
Patients diagnosed with MASLD;
Signed informed consent.

Who cannot join

Cervical length ≤ 25 mm;
History of threatened abortion;
Exercise contraindications or doctor advice not to exercise during pregnancy;
Current or previous use of drugs that affect body weight (such as hormones);
Patients with chronic hepatitis virus or other chronic liver diseases, excluding MASLD;
Non-natural conception or infertility treatment;
Any previous medication for hypertension, diabetes, heart disease, kidney disease, systemic lupus erythematosus, thyroid disease or mental illness;
Participating in other pregnancy intervention research projects.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050

Other trials in China

About this study

Official title: Evaluation of the Effect of Live Streaming Exercise on the Improvement of Hepatic Steatosis and Fibrosis in Pregnant Women With MASLD and Its Study Based on the Liver-gut Axis Mechanism.

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.

Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease
Being tested: Live Streaming Exercise
Keywords: Randomized Controlled Trial, Live streaming exercise

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Live Streaming ExerciseBehavioural
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.

Study groups in NCT06682663
Study group	Role	What they receive
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. Receives: Behavioral: Live Streaming Exercise
Regular care	No intervention	Regular care:health education.

What is being measured

The primary outcome is the main question the study is designed to answer.

Liver steatosis
LiSA, by Hepatus, Mindray, China；
Measured: Changes from the 14th week to 36 weeks + 6 days of pregnancy

Secondary outcomes (17)

Live stiffness measurement
E, by Hepatus, Mindray, China
Measured: Changes from the 14th week to 36 weeks +6 days of pregnancy
Gestational weight change
weight changes in kilograms
Measured: 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.
Measured: 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.
Measured: Changes from the 14th week to 36 weeks + 6 days of pregnancy
Changes in fasting blood glucose
with the routine check-up
Measured: Changes from the 14th week to 36 weeks +6 days of pregnancy
Changes in blood pressure
Both systolic and diastolic blood pressure are measured
Measured: Changes from the 14th week to 36 weeks + 6 days of pregnancy
Changes in alanine aminotransferase (ALT)
Measured: Changes from the 14th week to 36 weeks +6 days of pregnancy
Changes in aspartate aminotransferase (AST)
Measured: 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
Measured: Changes from the 14th week to 36 weeks + 6 days of pregnancy
Maternal sleep quality
sleep quality, which collected by Pittsburgh Sleep Quality Questionnaire
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 20248 Aug 2026

First posted12 Nov 2024
Study start18 Nov 2024
Primary completion31 May 2026
Study completion8 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (83)Papers the sponsor has linked to this study.
Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06682663
Sponsor's protocol ID: IRB00001052-24122
Status last verified: Dec 2025
First submitted: 6 Nov 2024
Last updated: 20 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 36626630
Zhou F, Zhou J, Wang W, Zhang XJ, Ji YX, Zhang P, She ZG, Zhu L, Cai J, Li H. Unexpected Rapid Increase in the Burden of NAFLD in China From 2008 to 2018: A Systematic Review and Meta-Analysis. Hepatology. 2019 Oct;70(4):1119-1133. doi: 10.1002/hep.30702.
PubMed 31070259
Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.
PubMed 26707365
Qian Y, Zhang Y, Fan X, Yan H, Li X, Fan Y, Song Y, Ma S, Hu Z, Gao X, Yang J. Nonalcoholic Fatty Liver Disease and Adverse Pregnancy Outcomes in Women With Normal Prepregnant Weight. J Clin Endocrinol Metab. 2023 Jan 17;108(2):463-471. doi: 10.1210/clinem/dgac567.
PubMed 36181486
Lee SM, Cho GJ, Wi WY, Norwitz ER, Koo BK, Lee J, Jung YM, Kwak SH, Park CW, Jun JK, Joo SK, Oh MJ, Kim W, Park JS. Metabolic dysfunction-associated fatty liver disease as a risk factor for adverse outcomes in subsequent pregnancy: a nationwide cohort study. Hepatol Int. 2023 Apr;17(2):367-376. doi: 10.1007/s12072-022-10458-w. Epub 2022 Dec 21.
PubMed 36542262
Chai TY, Byth K, George J, Pasupathy D, Cheung NW. Elevated Hepatic Steatosis Index is Associated with the Development of Adverse Maternal, but Not Adverse Neonatal, Outcomes: A Retrospective Cohort Study. Int J Womens Health. 2023 Apr 13;15:589-598. doi: 10.2147/IJWH.S399085. eCollection 2023.
PubMed 37077282
El Jamaly H, Eslick GD, Weltman M. Systematic review with meta-analysis: Non-alcoholic fatty liver disease and the association with pregnancy outcomes. Clin Mol Hepatol. 2022 Jan;28(1):52-66. doi: 10.3350/cmh.2021.0205. Epub 2021 Sep 17.
PubMed 34530527
Sarkar M, Grab J, Dodge JL, Gunderson EP, Rubin J, Irani RA, Cedars M, Terrault N. Non-alcoholic fatty liver disease in pregnancy is associated with adverse maternal and perinatal outcomes. J Hepatol. 2020 Sep;73(3):516-522. doi: 10.1016/j.jhep.2020.03.049. Epub 2020 Jun 9.
PubMed 32531415
Jung YM, Lee SM, Hong S, Koo JN, Oh IH, Kim BJ, Kim SM, Kim SY, Kim GM, Kyung Joo S, Shin S, Norwitz ER, Park CW, Jun JK, Kim W, Park JS. The risk of pregnancy-associated hypertension in women with nonalcoholic fatty liver disease. Liver Int. 2020 Oct;40(10):2417-2426. doi: 10.1111/liv.14563. Epub 2020 Jun 30.
PubMed 32558189
Lee SM, Kwak SH, Koo JN, Oh IH, Kwon JE, Kim BJ, Kim SM, Kim SY, Kim GM, Joo SK, Koo BK, Shin S, Vixay C, Norwitz ER, Park CW, Jun JK, Kim W, Park JS. Non-alcoholic fatty liver disease in the first trimester and subsequent development of gestational diabetes mellitus. Diabetologia. 2019 Feb;62(2):238-248. doi: 10.1007/s00125-018-4779-8. Epub 2018 Nov 23.
PubMed 30470912
Lee SM, Kim BJ, Koo JN, Norwitz ER, Oh IH, Kim SM, Kim SY, Kim GM, Kwak SH, Kim W, Joo SK, Shin S, Vixa C, Park CW, Jun JK, Park JS. Nonalcoholic fatty liver disease is a risk factor for large-for-gestational-age birthweight. PLoS One. 2019 Aug 26;14(8):e0221400. doi: 10.1371/journal.pone.0221400. eCollection 2019.
PubMed 31449538
Herath RP, Siriwardana SR, Ekanayake CD, Abeysekara V, Kodithuwakku SUA, Herath HP. Non-alcoholic fatty liver disease and pregnancy complications among Sri Lankan women: A cross sectional analytical study. PLoS One. 2019 Apr 12;14(4):e0215326. doi: 10.1371/journal.pone.0215326. eCollection 2019.
PubMed 30978266
Mousa N, Abdel-Razik A, Shams M, Sheta T, Zakaria S, Shabana W, Effat N, El-Diasty M, Abed S, Abd Elsalam M, Awad M, Salah M, El-Wakeel N, Deiab AG, Eldars W. Impact of non-alcoholic fatty liver disease on pregnancy. Br J Biomed Sci. 2018 Oct;75(4):197-199. doi: 10.1080/09674845.2018.1492205. Epub 2018 Aug 6. No abstract available.
PubMed 29943682
Hagstrom H, Hoijer J, Ludvigsson JF, Bottai M, Ekbom A, Hultcrantz R, Stephansson O, Stokkeland K. Adverse outcomes of pregnancy in women with non-alcoholic fatty liver disease. Liver Int. 2016 Feb;36(2):268-74. doi: 10.1111/liv.12902. Epub 2015 Sep 9.
PubMed 26114995
Cheng R, Wang L, Le S, Yang Y, Zhao C, Zhang X, Yang X, Xu T, Xu L, Wiklund P, Ge J, Lu D, Zhang C, Chen L, Cheng S. A randomized controlled trial for response of microbiome network to exercise and diet intervention in patients with nonalcoholic fatty liver disease. Nat Commun. 2022 May 10;13(1):2555. doi: 10.1038/s41467-022-29968-0.
PubMed 35538056

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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