Smartphone App for Non-alcoholic Fatty Liver Disease

NCT05180760 | Active Not Recruiting

• 1 other identifier: HKU01
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

Non-alcoholic fatty liver disease (NAFLD) is a disease spectrum that encompasses excessive liver deposition of fat (NAFL), non-alcoholic steatohepatitis (NASH), and NASH cirrhosis. NAFLD is regarded as the hepatic manifestation of metabolic syndrome and is currently the most common etiology for chronic liver disease worldwide, affecting 25% of the adult population globally. It is estimated that cirrhosis and liver-related death occur in 20% and 12%, respectively, over a 10-year period in patients with NAFLD. The incidence of decompensated cirrhosis and hepatocellular carcinoma (HCC) due to NAFLD are increasing with time. In United States, the number of patient listing for liver transplantation (LT) due to NAFLD has surpassed that of from chronic viral hepatitis and is currently the second leading cause for LT waitlist overall. Locally, the prevalence of NAFLD is estimated to be 42% according to a health census in healthy blood donors in Hong Kong, and up to 13.5% healthy subjects will develop new onset NAFLD in 3-5 years of follow-up. Clearly, NAFLD is a chronic liver disease with alarmingly high prevalence that warrants attention. Despite the high prevalence and potential to develop serious liver-related morbidity, there are currently no approved drugs for patients with NAFLD. To achieve resolution of steatohepatitis and improvement of liver fibrosis, weight loss appears to be the only effective means. This study is aimed to evaluate the effectiveness of a self-developed smartphone app for achieving weight loss in Chinese adults with non-alcoholic fatty-liver disease (NAFLD) at 12 months. Endorsed by the WHO, mobile technology is being increasingly used to promote health. There is a lack of research on the use of mobile technology for promoting weight loss in Chinese NAFLD patients.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

non-alcoholic fatty liver disease; telemedicine; mobile health; self-management

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Body weight of the participants will be measured at baseline and 12 months

  12 months

Secondary Outcomes (6)

• Reduction in hepatic steatosis

  12 months

• ALT normalization

  12 months

• Reversal of sarcopenia

  12 months

• Changes in lipid profile

  12 months

• Changes in glucose levels

  12 months

Study Arms (2)

Smartphone app arm

ACTIVE COMPARATOR

Use the dedicated smartphone app for NAFLD patients

Behavioral: Smartphone app use

Standard of care

OTHER

Standard of care

Behavioral: Standard of care

Interventions

Smartphone app use BEHAVIORAL

Smartphone app use in the active arm

Smartphone app arm

Standard of care BEHAVIORAL

Standard of care

Standard of care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• known NAFLD
• able to read and understand Chinese
• owns a compatible smartphone
• without major cognitive impairment.

You may not qualify if:

• newly initiated on sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists or thiazolidinediones or had recent dose adjustments (within 3 months)
• patients with cirrhosis
• patients who are pregnant
• patients on special diet or with special dietary requirement (e.g. vegan, gluten free)
• patients with heavy alcohol use (≥20 grams/ day for women or ≥30 grams/ day for men)
• history of HCC or LT

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, 0000, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lung-Yi Mak, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 6, 2022
• Study Start: July 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)