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| ID | Type | Description | Link |
|---|---|---|---|
| P20GM130414-06S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Intervention | Active Comparator | Participants randomly assigned to this arm will receive psychotherapy utilizing manualized principles of motivational interviewing with standard health information. |
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| Enhanced Intervention | Experimental | Participants randomly assigned to this arm will receive psychotherapy utilizing manualized principles of motivational interviewing that incorporates personalized feedback on self-reported alcohol intake and two scores from Fibroscan® liver imaging that indicate steatosis (liver fat) and fibrosis (liver scaring). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief motivational interviewing with personalized feedback | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion Screened With Alcohol Intake and Weight-related Risks for Metabolism and Alcohol-associated Liver Disease | 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. | Screening |
| 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 | Satisfaction with liver screening is assessed with a single-item visual analog scale with 0 indicating low satisfaction and 100 indicating high satisfaction. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Intake Assessed by Timeline Followback Interview Before and 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Esperanza Hope Clinic | Providence | Rhode Island | 02909 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Intervention | Participants randomly assigned to this arm will receive psychotherapy utilizing manualized principles of motivational interviewing with standard health information. Brief 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. |
| FG001 | Enhanced Intervention | Participants randomly assigned to this arm will receive psychotherapy utilizing manualized principles of motivational interviewing that incorporates personalized feedback on self-reported alcohol intake and two scores from Fibroscan® liver imaging that indicate steatosis (liver fat) and fibrosis (liver scaring). Brief motivational interviewing with personalized feedback: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Intervention | Participants randomly assigned to this arm will receive psychotherapy utilizing manualized principles of motivational interviewing with standard health information. Brief 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion Screened With Alcohol Intake and Weight-related Risks for Metabolism and Alcohol-associated Liver Disease | 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. | This is the number of participants who were identified by electronic health record reviews who responded to pre-screening questions. | Posted | Count of Participants | Participants | Screening |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Intervention | Participants randomly assigned to this arm will receive psychotherapy utilizing manualized principles of motivational interviewing with standard health information. Brief 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director of Team Science | Center for Addiction and Disease Risk Exacerbation | 4018636623 | liverhealth@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 30, 2024 | Jan 15, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 27, 2024 | Jan 15, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 4, 2024 | Feb 3, 2026 | ICF_002.pdf |
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|
| Brief motivational interviewing with standard health information | Behavioral | 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. |
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| 30 days prior to intervention and 30 days after intervention |
| BG001 | Enhanced Intervention | Participants randomly assigned to this arm will receive psychotherapy utilizing manualized principles of motivational interviewing that incorporates personalized feedback on self-reported alcohol intake and two scores from Fibroscan® liver imaging that indicate steatosis (liver fat) and fibrosis (liver scaring). Brief motivational interviewing with personalized feedback: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| High Body Mass Index Stratification Group | Count of Participants | Participants |
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| High Alcohol Consumption Level Stratification Group | Count of Participants | Participants |
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| Primary | Proportion Eligible and Invited to Participate Who Agree to Noninvasive Liver Imaging With Fibroscan® and Arrive for Scheduled Baseline Appointment | Posted | Count of Participants | Participants | Baseline |
|
|
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| Primary | Satisfaction With Fibroscan® Liver Imaging | Satisfaction with liver screening is assessed with a single-item visual analog scale with 0 indicating low satisfaction and 100 indicating high satisfaction. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Secondary | Alcohol Intake Assessed by Timeline Followback Interview Before and 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. | Not Posted | 30 days prior to intervention and 30 days after intervention | Participants |
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Enhanced Intervention | Participants randomly assigned to this arm will receive psychotherapy utilizing manualized principles of motivational interviewing that incorporates personalized feedback on self-reported alcohol intake and two scores from Fibroscan® liver imaging that indicate steatosis (liver fat) and fibrosis (liver scaring). Brief motivational interviewing with personalized feedback: 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. | 0 | 8 | 0 | 8 | 0 | 8 |
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