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RecruitingNCT07450144Updated Mar 23, 2026

A Large Language Model-based Chatbot for Alcohol Reduction in Patients With Metabolic Alcohol-Related Liver Disease

An interventional study of LLM-based chatbot and Telephone counseling in Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Alcohol-Related Liver Disease, sponsored by The University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-23.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. To assess how many MetALD patients accept the invitation to participate in the trial
  2. To assess the retention rate of the participants through 3 and 6 months after treatment initiation
  3. To assess the acceptability of the LLM-based chatbot in terms of participants' compliance and usability rating
  4. To estimate the intervention effect on alcohol reduction
  5. To explore the participants' perception and experiences in the chatbot
02

Conditions studied

  • Metabolic Dysfunction-Associated Steatotic Liver Disease
  • Metabolic Alcohol-Related Liver Disease

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Keywords

  • drinking
  • Chinese
  • mHealth
  • WhatsApp
  • BCTs
  • COM-B model
  • cirrhosis
  • Large language model
  • AI-based chatbot
03

In context

Fibrosis

3,255 studies on the registry are indexed under Fibrosis; 465 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 2,130 interventional studies indexed under Fibrosis.

Browse Fibrosis studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

1. Hong Kong residents aged 18 years or above 2. Diagnosed of MASLD:

  1. 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
  2. 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

Exclusion criteria

Exclusion Criteria:

  1. Diagnosed with mental disease or cognitive impairments, or
  2. Participating in other ongoing clinic trials
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    LLM-based chatbot

    LLM-based chatbot + Alcohol Brief Intervention

    Behavioral: LLM-based chatbot · Behavioral: Alcohol Brief Intervention

  • Active comparator
    Telephone counseling

    Telephone counseling + Alcohol Brief Intervention

    Behavioral: Telephone counseling · Behavioral: Alcohol Brief Intervention

Interventions

  • BehavioralLLM-based chatbot

    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.

  • BehavioralTelephone counseling

    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.

  • BehavioralAlcohol Brief Intervention

    Brief counselling (5 to 10 mins) to reduce drinking and a self-help booklet

06

What researchers measure

Primary outcomes

  1. Recruitment rate

    Number of participants divided by the number of eligible subjects

    Time frame: Through recruitment completion, about 12 months

  2. Retention rate

    Number of participants completed the follow-up divided by the number of participants

    Time frame: 6 months after randomisation

  3. Weekly alcohol consumption

    Assessed by questions 1 and 2 of AUDIT-C

    Time frame: 3 months after randomisation

Secondary outcomes

  1. Eligibility rate

    Number of eligible patients divided by the number of patients screened

    Time frame: Through recruitment completion, about 12 months

  2. Weekly alcohol consumption

    Assessed by questions 1 and 2 of AUDIT-C

    Time frame: 6 months after randomisation

  3. Frequency of binge drinking in the past 30 days

    Self-reported

    Time frame: 3 months after randomisation

  4. Frequency of binge drinking in the past 30 days

    Self-reported

    Time frame: 6 months after randomisation

  5. Frequency of heavy drinking in the past 30 days

    Self-reported

    Time frame: 3 months after randomisation

  6. Frequency of heavy drinking in the past 30 days

    Self-reported

    Time frame: 6 months after randomisation

  7. AUDIT score and level

    Assessed by the Alcohol Use Disorders Identification Test

    Time frame: 3 months after randomisation

  8. AUDIT score and level

    Assessed by the Alcohol Use Disorders Identification Test

    Time frame: 6 months after randomisation

  9. Planned drinking in the coming 30 days

    Self-reported

    Time frame: 3 months after randomisation

  10. Planned drinking in the coming 30 days

    Self-reported

    Time frame: 6 months after randomisation

07

Study locations

1 of 1 sites recruiting
  • Hong Kong Queen Mary Hospital
    Hong Kong, Hong Kong
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07450144
Lead sponsor
The University of Hong Kong
Responsible party
Prof. Wang Man-Ping (Professor, The University of Hong Kong) — Principal investigator
First posted
Mar 4, 2026
Start date
Mar 18, 2026 (estimated)
Primary completion
May 22, 2027 (estimated)
Completion
Jul 22, 2027 (estimated)
Last update
Mar 23, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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