Status:
RECRUITING
Team Science (The Liver Health Study)
Lead Sponsor:
Brown University
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Steatotic Liver Disease of Mixed Origin (MetALD)
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Liver damage from alcohol intake and weight-related behaviors is preventable and treatable only through lifestyle changes. This mixed-methods randomized controlled trial compares standard and enhanced...
Eligibility Criteria
Inclusion
- Be at least 21 years of age.
- Exceed alcohol intake screening guidelines for MetALD.
- Have a Body Mass Index (BMI) \>=25 kg/m2.
- Be able to speak and read English or Spanish to provide written informed consent and understand written and oral instructions in English or Spanish.
Exclusion
- Pre-existing liver disease or hepatocellular carcinoma or prior liver transplant.
- Pre-existing medical conditions that, in the opinion of the investigative team, would interfere with research participation (e.g., loss of kidney function, uncontrolled infections, multiorgan failure, uncontrolled upper gastrointestinal bleeding, other active malignancies except skin cancer).
- Pre-existing mental health conditions that, in the opinion of the investigative team, would interfere with the ability to provide informed consent and understand written and oral instructions (e.g., hepatic encephalopathy, psychotic disorder diagnosis or symptoms).
- Current pregnancy.
- Be anyone who, based on self-reported withdrawal symptoms and the opinion of the investigative team, could not currently safely be withdrawn from alcohol without medical detoxification.
- Currently receiving formalized psychosocial treatment for an alcohol use or drug problem and/or newly taking medications for an alcohol use or drug problem.
- Currently receiving formalized behavioral weight management treatment and/or newly taking weight loss medications.
Key Trial Info
Start Date :
April 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06924281
Start Date
April 25 2025
End Date
July 31 2025
Last Update
May 1 2025
Active Locations (1)
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1
Clinica Esperanza Hope Clinic
Providence, Rhode Island, United States, 02909