Metabolic Dysfunction-Associated Steatotic Liver DiseaseNCT07450144
A Large Language Model-based Chatbot for Alcohol Reduction in Patients With Metabolic Alcohol-Related Liver Disease
A study testing LLM-based chatbot, Telephone counseling and Alcohol Brief Intervention in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Alcohol-Related Liver Disease, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this pilot randomized controlled trial is to evaluate the trial feasibility and acceptability of LLM-based chatbot for reducing alcohol use among patients with metabolic alcohol-related liver disease. Specific objectives include: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Alcohol-Related Liver Disease
- What is being tested?
- LLM-based chatbot, Telephone counseling and Alcohol Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Mar 2026to 22 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Hong Kong residents aged 18 years or above 2. Diagnosed of MASLD:
- Evidence of hepatic steatosis (fat accumulation in the liver) confirmed by imaging techniques such as ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), or liver biopsy
- Presence of metabolic dysfunction, indicated by at least one of the following:
- Overweight or obesity (body mass index [BMI] ≥25 kg/m²),
- Type 2 diabetes mellitus, ③Dyslipidemia (elevated triglycerides [≥150 mg/dL] or low high-density lipoprotein [HDL] cholesterol [<40 mg/dL for men, <50 mg/dL for women]), ④Hypertension (blood pressure ≥130/85 mmHg or use of antihypertensive medication).
- Metabolic syndrome as defined by established criteria (e.g., International Diabetes Federation [IDF], Adult Treatment Panel III [ATP III]) 3. Alcohol consumption: males who drink 210-420 g/week (≈263-525 ml), female who drink 140-350 g/week (≈175-438 ml) 4. Intention to reduce/quit alcohol 5. Able to read and communicate in Chinese 6. Own a smartphone with internet access
Who cannot join
- Diagnosed with mental disease or cognitive impairments, or
- Participating in other ongoing clinic trials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Queen Mary Hospital
Hong Kong
Man Ping Wang, Prof, +85239176636, mpwang@hku.hk
About this study
Official title: A Large Language Model-based Chatbot for Alcohol Reduction Counseling in MetALD Patients: A Pilot Randomized Controlled Trial
The goal of this pilot randomized controlled trial is to evaluate the trial feasibility and acceptability of LLM-based chatbot for reducing alcohol use among patients with metabolic alcohol-related liver disease. Specific objectives include:
- To assess how many MetALD patients accept the invitation to participate in the trial
- To assess the retention rate of the participants through 3 and 6 months after treatment initiation
- To assess the acceptability of the LLM-based chatbot in terms of participants' compliance and usability rating
- To estimate the intervention effect on alcohol reduction
- To explore the participants' perception and experiences in the chatbot
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Alcohol-Related Liver Disease
- Being tested
- LLM-based chatbot, Telephone counseling, Alcohol Brief Intervention
- Keywords
- drinking, Chinese, mHealth, WhatsApp, BCTs, COM-B model, cirrhosis, Large language model, AI-based chatbot
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLM-based chatbotBehavioural
Over the three months following randomisation, an LLM-based chatbot will interact with each participant individually to deliver four personalized sessions of alcohol reduction information and advice, and participants will also be allowed to contact the chatbot at any time.
Telephone counselingBehavioural
Over the three months following randomisation, a trained counsellor will conduct four individual daytime telephone sessions with each participant to provide personalised information and advice on reducing alcohol consumption.
Alcohol Brief InterventionBehavioural
Brief counselling (5 to 10 mins) to reduce drinking and a self-help booklet
| Study group | Role | What they receive |
|---|---|---|
| LLM-based chatbot | Experimental | LLM-based chatbot + Alcohol Brief Intervention Receives: Behavioral: LLM-based chatbot; Behavioral: Alcohol Brief Intervention |
| Telephone counseling | Active comparator | Telephone counseling + Alcohol Brief Intervention Receives: Behavioral: Telephone counseling; Behavioral: Alcohol Brief Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of participants divided by the number of eligible subjects
Measured: Through recruitment completion, about 12 months
Retention rate
Number of participants completed the follow-up divided by the number of participants
Measured: 6 months after randomisation
Weekly alcohol consumption
Assessed by questions 1 and 2 of AUDIT-C
Measured: 3 months after randomisation
Secondary outcomes (10)
Eligibility rate
Number of eligible patients divided by the number of patients screened
Measured: Through recruitment completion, about 12 months
Weekly alcohol consumption
Assessed by questions 1 and 2 of AUDIT-C
Measured: 6 months after randomisation
Frequency of binge drinking in the past 30 days
Self-reported
Measured: 3 months after randomisation
Frequency of binge drinking in the past 30 days
Self-reported
Measured: 6 months after randomisation
Frequency of heavy drinking in the past 30 days
Self-reported
Measured: 3 months after randomisation
Frequency of heavy drinking in the past 30 days
Self-reported
Measured: 6 months after randomisation
AUDIT score and level
Assessed by the Alcohol Use Disorders Identification Test
Measured: 3 months after randomisation
AUDIT score and level
Assessed by the Alcohol Use Disorders Identification Test
Measured: 6 months after randomisation
Planned drinking in the coming 30 days
Self-reported
Measured: 3 months after randomisation
Planned drinking in the coming 30 days
Self-reported
Measured: 6 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start18 Mar 2026 (estimated)
- Primary completion22 May 2027 (estimated)
- Study completion22 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Wang Man-Ping, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450144
- Sponsor's protocol ID
- MetALD
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Large Language Model-based Chatbot for Alcohol Reduction Counseling in MetALD Patients: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07450144
- Acronym / sponsor ID
- MetALD
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Alcohol-Related Liver Disease
- Keywords
- drinking, Chinese, mHealth, WhatsApp, BCTs, COM-B model, cirrhosis, Large language model
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 18 Mar 2026 (estimated)
- Primary completion
- 22 May 2027 (estimated)
- Study completion
- 22 Jul 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot randomized controlled trial is to evaluate the trial feasibility and acceptability of LLM-based chatbot for reducing alcohol use among patients with metabolic alcohol-related liver disease. Specific objectives include:
- To assess how many MetALD patients accept the invitation to participate in the trial
- To assess the retention rate of the participants through 3 and 6 months after treatment initiation
- To assess the acceptability of the LLM-based chatbot in terms of participants' compliance and usability rating
- To estimate the intervention effect on alcohol reduction
- To explore the participants' perception and experiences in the chatbot
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLM-based chatbot | Experimental | Behavioral: LLM-based chatbot, Behavioral: Alcohol Brief InterventionLLM-based chatbot + Alcohol Brief Intervention |
| Telephone counseling | Active comparator | Behavioral: Telephone counseling, Behavioral: Alcohol Brief InterventionTelephone counseling + Alcohol Brief Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Evidence of hepatic steatosis (fat accumulation in the liver) confirmed by imaging techniques such as ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), or liver biopsy
- Presence of metabolic dysfunction, indicated by at least one of the following:
Key exclusion criteria (2 listed)
- Diagnosed with mental disease or cognitive impairments, or
- Participating in other ongoing clinic trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LLM-based chatbotOver the three months following randomisation, an LLM-based chatbot will interact with each participant individually to deliver four personalized sessions of alcohol reduction information and advice, and participants will also be allowed to contact the chatbot at any time. | Behavioural | LLM-based chatbot |
| Telephone counselingOver the three months following randomisation, a trained counsellor will conduct four individual daytime telephone sessions with each participant to provide personalised information and advice on reducing alcohol consumption. | Behavioural | Telephone counseling |
| Alcohol Brief InterventionBrief counselling (5 to 10 mins) to reduce drinking and a self-help booklet | Behavioural | LLM-based chatbot, Telephone counseling |
Primary outcome
Recruitment rate
Time frame: Through recruitment completion, about 12 months
Number of participants divided by the number of eligible subjects
Retention rate
Time frame: 6 months after randomisation
Number of participants completed the follow-up divided by the number of participants
Weekly alcohol consumption
Time frame: 3 months after randomisation
Assessed by questions 1 and 2 of AUDIT-C
10 secondary outcomes
Eligibility rate
Time frame: Through recruitment completion, about 12 months
Weekly alcohol consumption
Time frame: 6 months after randomisation
Frequency of binge drinking in the past 30 days
Time frame: 3 months after randomisation
Frequency of binge drinking in the past 30 days
Time frame: 6 months after randomisation
Frequency of heavy drinking in the past 30 days
Time frame: 3 months after randomisation
Frequency of heavy drinking in the past 30 days
Time frame: 6 months after randomisation
AUDIT score and level
Time frame: 3 months after randomisation
AUDIT score and level
Time frame: 6 months after randomisation
Planned drinking in the coming 30 days
Time frame: 3 months after randomisation
Planned drinking in the coming 30 days
Time frame: 6 months after randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LLM-based chatbot, Telephone counseling and Alcohol Brief Intervention in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Alcohol-Related Liver Disease, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Through recruitment completion, about 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.