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

NCT06682663 | Not Yet Recruiting

• 1 other identifier: IRB00001052-24122
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Dysfunction-associated Steatotic Liver Disease

Keywords

Randomized Controlled Trial; Live streaming exercise

Outcome Measures

Primary Outcomes (2)

• Liver steatosis

  LiSA, by Hepatus, Mindray, China；

  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

Secondary Outcomes (16)

• Gestational weight change

  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

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

• Changes in fasting serum lipids(TG, TC, LDL, HDL)

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

• Changes in fasting blood glucose

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

• Changes in blood pressure

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

Study Arms (2)

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.

Behavioral: Live Streaming Exercise

Regular care

NO INTERVENTION

Regular care:health education.

Interventions

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.

Live Streaming Exercise

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead
• Beijing Friendship Hospital: collaborator
• W.F. Maternal and Child Health Hospital: collaborator

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Study Officials

• Hui Wang, Ph.D

  Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Wang, Ph.D

CONTACT

19800363805; huiwang@bjmu.edu.cn

Mingyue Wang, MD

CONTACT

19862183196; 2311110212@stu.pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 12, 2024
• Study Start: November 18, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share