Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Alcohol-Related Liver Disease
Conditions
Keywords
drinking, Chinese, mHealth, WhatsApp, BCTs, COM-B model, cirrhosis, Large language model, AI-based chatbot
Brief 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
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
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Single (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
1. Diagnosed with mental disease or cognitive impairments, or 2. Participating in other ongoing clinic trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | Through recruitment completion, about 12 months | Number of participants divided by the number of eligible subjects |
| Retention rate | 6 months after randomisation | Number of participants completed the follow-up divided by the number of participants |
| Weekly alcohol consumption | 3 months after randomisation | Assessed by questions 1 and 2 of AUDIT-C |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eligibility rate | Through recruitment completion, about 12 months | Number of eligible patients divided by the number of patients screened |
| Weekly alcohol consumption | 6 months after randomisation | Assessed by questions 1 and 2 of AUDIT-C |
| Frequency of binge drinking in the past 30 days | 3 months after randomisation | Self-reported |
| Frequency of heavy drinking in the past 30 days | 3 months after randomisation | Self-reported |
| AUDIT score and level | 3 months after randomisation | Assessed by the Alcohol Use Disorders Identification Test |
| Planned drinking in the coming 30 days | 3 months after randomisation | Self-reported |
Countries
Hong Kong
Outcome results
None listed