Steatotic Liver Disease of Mixed Origin (MetALD)
Conditions
Keywords
Metabolism and alcohol-associated liver disease, Motivational interviewing, Personalized feedback
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.
Interventions
The manualized intervention is delivered individually in two phases by an interventionist trained in motivational interviewing. The intervention includes liver health information and explains connections with weight-related behaviors. The enhanced (experimental) group receives personalized feedback, i.e., a summary of self-reported drinking patterns and results of liver imaging with Fibroscan®, i.e., steatosis (liver fat) and fibrosis (liver scaring) scores. The feedback is used to develop discrepancies between a goal of halting or reversing health risks associated with consuming alcohol versus continuing to drink. The sessions are matched in duration and interventionist skill level with the standard (control) group.
BEHAVIORALBrief motivational interviewing with standard health information
The manualized intervention is delivered individually in two phases by an interventionist trained in motivational interviewing. The intervention includes liver health information and explains connections with weight-related behaviors. The standard (control) group does not receive personalized feedback. The sessions are matched in duration and interventionist skill level with the enhanced (experimental) group.
Sponsors
Brown University
National Institute of General Medical Sciences (NIGMS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion Screened With Alcohol Intake and Weight-related Risks for Metabolism and Alcohol-associated Liver Disease | Screening | The primary feasibility outcome is the proportion screened who have alcohol intake and weight-related risks for metabolism and alcohol-associated liver disease. Alcohol intake risk is identified by the 3-item Alcohol Use Disorder Identification Test-Consumption subscale (AUDIT-C). Weight-related risk is identified by body mass index, calculated from weight and height. |
| Proportion Eligible and Invited to Participate Who Agree to Noninvasive Liver Imaging With Fibroscan® and Arrive for Scheduled Baseline Appointment | Baseline | — |
| Satisfaction With Fibroscan® Liver Imaging | Baseline | Satisfaction with liver screening is assessed with a single-item visual analog scale with 0 indicating low satisfaction and 100 indicating high satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Intake Assessed by Timeline Followback Interview Before and After Intervention | 30 days prior to intervention and 30 days after intervention | Timeline followback interviews will be individually administered in a semi-structured format by outcomes assessors who are masked to intervention condition. Interviews follow standardized procedures using a 30-day calendar to identify anchoring events, abstinent days, and types of alcohol consumed including ounces and alcohol by volume. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 41 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| High Alcohol Consumption Level Stratification Group | 6 Participants |
| High Body Mass Index Stratification Group | 2 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 8 |
| other Total, other adverse events | 0 / 6 | 0 / 8 |
| serious Total, serious adverse events | 0 / 6 | 0 / 8 |
Outcome results
None listed