Testing a Multilevel, Culturally Appropriate Lifestyle Intervention For Hispanic Patients With Metabolic-dysfunction Associated Steatotic Liver Disease
NCT ID: NCT07199491
Last Updated: 2025-09-30
Study Results
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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NOT_YET_RECRUITING
NA
64 participants
INTERVENTIONAL
2025-10-01
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Healthy Liver/Hígado Sano program
Healthy Liver/Hígado Sano program
Participants will attend weekly classes over the 6-month period. This consists of 16 core sessions delivered in the first 6 months (weekly, but with flexibility to skip weeks as necessary due to holidays, etc). The sessions are 30-60 minutes long, conducted in a group setting, with a CDC-certified Lifestyle Coach facilitating the sessions.
Usual Care
Usual Care
participants will first complete a 30- to 45-minute questionnaire that will cover topics such as physical activity, diet, alcohol use, and stress.Participants will then be asked to wear an accelerometer for 7 days and complete a log to identify when it was worn and removed each day.Height and weight will also be measured and a Fibroscan® assessment (to measure amount of fat and scar tissue in the liver), as well as blood work to monitor the liver enzymes will be done
Interventions
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Healthy Liver/Hígado Sano program
Participants will attend weekly classes over the 6-month period. This consists of 16 core sessions delivered in the first 6 months (weekly, but with flexibility to skip weeks as necessary due to holidays, etc). The sessions are 30-60 minutes long, conducted in a group setting, with a CDC-certified Lifestyle Coach facilitating the sessions.
Usual Care
participants will first complete a 30- to 45-minute questionnaire that will cover topics such as physical activity, diet, alcohol use, and stress.Participants will then be asked to wear an accelerometer for 7 days and complete a log to identify when it was worn and removed each day.Height and weight will also be measured and a Fibroscan® assessment (to measure amount of fat and scar tissue in the liver), as well as blood work to monitor the liver enzymes will be done
Eligibility Criteria
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Inclusion Criteria
* Have been diagnosed with MASLD
* Able to speak English or Spanish
* Have access to internet, either on their phone, at home or at some other location convenient to the participant
* Have a family member willing to attend all sessions
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Natalia Heredia
Assistant Professor
Principal Investigators
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Natalia Heredia
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Natalia Heredia
Role: primary
Other Identifiers
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HSC-SPH-25-0539
Identifier Type: -
Identifier Source: org_study_id