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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

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. Read more about this study

Who is it for?
Ages 20 to 45 years, women only
What is being tested?
Live Streaming Exercise
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
Are there results?
None posted in the registry

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.

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 groupRoleWhat they receive
Live Streaming ExerciseExperimentalLive 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 careNo interventionRegular care:health education.

What is being measured

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

  1. Liver steatosis

    LiSA, by Hepatus, Mindray, China；

    Measured: Changes from the 14th week to 36 weeks + 6 days of pregnancy

Secondary outcomes (17)

  1. Live stiffness measurement

    E, by Hepatus, Mindray, China

    Measured: Changes from the 14th week to 36 weeks +6 days of pregnancy

  2. Gestational weight change

    weight changes in kilograms

    Measured: Changes from the 14th week to 36 weeks + 6 days of pregnancy

  3. 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

  4. 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

  5. Changes in fasting blood glucose

    with the routine check-up

    Measured: Changes from the 14th week to 36 weeks +6 days of pregnancy

  6. 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

  7. Changes in alanine aminotransferase (ALT)

    Measured: Changes from the 14th week to 36 weeks +6 days of pregnancy

  8. Changes in aspartate aminotransferase (AST)

    Measured: Changes from the 14th week to 36 weeks + 6 days of pregnancy

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  1. First posted12 Nov 2024
  2. Study start18 Nov 2024
  3. Primary completion31 May 2026
  4. Study completion8 Aug 2026

Resources

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

Questions about this trial

What is this clinical trial studying?

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

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Liver steatosis (time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06682663, which also lists 83 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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