A study on improving liver health through lifestyle changes
Team Science to Identify & Intervene on Metabolism- & Alcohol-Associated Liver Disease
This study is testing if making lifestyle changes can help adults at risk for liver damage from alcohol and weight issues feel better and improve their liver health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Brown University Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT06924281 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on preventing and treating liver damage caused by alcohol intake and weight-related behaviors through lifestyle changes. It compares standard and enhanced approaches to screening, brief intervention, and referral to treatment for metabolism- and alcohol-associated liver disease (MetALD). The study utilizes noninvasive liver screening with Fibroscan®, a painless ultrasound technique, to optimize brief interventions. Participants are adults aged 21 and older from underresourced communities who speak either Spanish or English and are at risk for MetALD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who exceed alcohol intake guidelines and have a BMI of 25 or higher.
Not a fit: Patients with pre-existing liver disease, severe medical conditions, or mental health issues that impair consent or understanding will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective lifestyle intervention strategies to prevent and treat liver disease in at-risk populations.
How similar studies have performed: Other studies have shown success with similar lifestyle intervention approaches for liver health, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Providence, Rhode Island
- Clinica Esperanza Hope Clinic — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Study coordinator: Primary Researcher
- Email: liverhealth@brown.edu
- Phone: 401-863-6623
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.