Impact of Live Streaming Exercise on Liver Health in MASLD Pregnant Women
NCT ID: NCT06682663
Last Updated: 2024-11-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
220 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-11-18
Study Completion Date
2026-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Metabolic Dysfunction-associated Steatotic Liver Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Investigators
Outcome Assessors
Study Groups
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Live Streaming Exercise
Live Streaming Exercise:Conduct supervised exercise guidance interventions from the 14th week of pregnancy and continuing through the 36+6th week.
Group Type
EXPERIMENTAL
Live Streaming Exercise
Intervention Type
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.
Regular care
Regular care:health education.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Live 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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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.
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.
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.
Minimum Eligible Age
20 Years
Maximum Eligible Age
45 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Beijing Friendship Hospital
OTHER
Sponsor Role
collaborator
W.F. Maternal and Child Health Hospital
UNKNOWN
Sponsor Role
collaborator
Peking University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Hui Wang, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Peking University
Central Contacts
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References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB00001052-24122
Identifier Type: -
Identifier Source: org_study_id
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