Clinical trial NCT06924281: Team Science (The Liver Health Study)
Official title: Team Science to Identify & Intervene on Metabolism- & Alcohol-Associated Liver Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Steatotic Liver Disease of Mixed Origin (MetALD)
Keywords: Metabolism and alcohol-associated liver disease
Motivational interviewing
Personalized feedback
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2025-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 approaches to screening, brief intervention, and referral to treatment/prevention (SBIRT/P) to identify and intervene for metabolism- and alcohol-associated liver disease (MetALD). Our multidisciplinary team aims to show that integrating results of noninvasive liver screening with Fibroscan®, a painless ultrasound that measures stiffness and fat in the liver, can optimize our brief intervention. The study population is adults age 21+ who speak Spanish or English from underresourced communities with alcohol- and weight-related risks for MetALD.


Eligibility 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.

Primary outcomes:
measure: Proportion Screened with Alcohol Intake and Weight-related Risks for Metabolism and Alcohol-associated Liver Disease
timeFrame: Screening
measure: Proportion Eligible and Invited to Participate Who Agree to Noninvasive Liver Imaging with Fibroscan® and Arrive for Scheduled Baseline Appointment
timeFrame: Baseline
measure: Satisfaction with Fibroscan® Liver Imaging
timeFrame: Baseline
Secondary outcomes:
measure: Alcohol Intake Assessed by Timeline Followback Interview Before and After Intervention
timeFrame: 30 days prior to intervention and 30 days after intervention
Other outcomes:
Locations:
city: Providence
country: United States
facility: Clinica Esperanza Hope Clinic
state: Rhode Island
Study officials:
References: