Trial Outcomes & Findings for Team Science (The Liver Health Study) (NCT NCT06924281)
NCT ID: NCT06924281
Last Updated: 2026-02-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
Screening
Results posted on
2026-02-04
Participant Flow
Participant milestones
| Measure |
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.
|
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.
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|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
|
Overall Study
COMPLETED
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Team Science (The Liver Health Study)
Baseline characteristics by cohort
| Measure |
Standard Intervention
n=6 Participants
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.
|
Enhanced Intervention
n=8 Participants
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.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 13 • n=41 Participants
|
44 years
STANDARD_DEVIATION 17 • n=1581 Participants
|
43 years
STANDARD_DEVIATION 15 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=41 Participants
|
8 Participants
n=1581 Participants
|
14 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=41 Participants
|
8 participants
n=1581 Participants
|
14 participants
n=4626 Participants
|
|
High Body Mass Index Stratification Group
|
3 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
|
High Alcohol Consumption Level Stratification Group
|
2 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: ScreeningPopulation: This is the number of participants who were identified by electronic health record reviews who responded to pre-screening questions.
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.
Outcome measures
| Measure |
Pre-randomization Screening Phase
n=58 Participants
Arm/group is not applicable for this primary outcome measure, as screening occurred prior to randomization to standard/enhanced intervention groups.
|
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.
|
|---|---|---|
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Proportion Screened With Alcohol Intake and Weight-related Risks for Metabolism and Alcohol-associated Liver Disease
|
26 Participants
|
—
|
PRIMARY outcome
Timeframe: BaselineOutcome measures
| Measure |
Pre-randomization Screening Phase
n=17 Participants
Arm/group is not applicable for this primary outcome measure, as screening occurred prior to randomization to standard/enhanced intervention groups.
|
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.
|
|---|---|---|
|
Proportion Eligible and Invited to Participate Who Agree to Noninvasive Liver Imaging With Fibroscan® and Arrive for Scheduled Baseline Appointment
|
14 Participants
|
—
|
PRIMARY outcome
Timeframe: BaselineSatisfaction with liver screening is assessed with a single-item visual analog scale with 0 indicating low satisfaction and 100 indicating high satisfaction.
Outcome measures
| Measure |
Pre-randomization Screening Phase
n=6 Participants
Arm/group is not applicable for this primary outcome measure, as screening occurred prior to randomization to standard/enhanced intervention groups.
|
Enhanced Intervention
n=8 Participants
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.
|
|---|---|---|
|
Satisfaction With Fibroscan® Liver Imaging
|
88.5 units on a scale
Standard Deviation 11.2
|
93.9 units on a scale
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: 30 days prior to intervention and 30 days after interventionTimeline 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.
Outcome measures
Outcome data not reported
Adverse Events
Standard Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Associate Director of Team Science
Center for Addiction and Disease Risk Exacerbation
Phone: 4018636623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place