Smartphone App for Non-alcoholic Fatty Liver Disease

NCT ID: NCT05180760

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2026-12-31

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.

Detailed Description

The Investigators formed a multi-disciplinary team consisting of hepatologist, computer scientist, dietitian and endocrinologist. The investigators hypothesize that NAFLD subjects who use the dedicated smartphone app will achieve more weight loss than subjects who are managed with standard of care (SOC) without smartphone app.

The present study is a multi-center, two-arm randomized, placebo-controlled, 1:1 trial to examine the effectiveness of a self-developed simple-to-use smartphone app for NAFLD patients. The smartphone app consists of elements that track health data, provide health education, estimate calorie intake and energy expenditure. Anthropometric measurements, blood tests, transient elastography, and bioelectrical impedance analysis will be performed at baseline and 12 months. The intervention is either Smartphone app vs SOC. The main outcome measures will include changes in body weight, liver fat, liver enzyme, muscle mass, lipid and glucose profile.

Conditions

Non-Alcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Smartphone app arm

Use the dedicated smartphone app for NAFLD patients

Group Type: ACTIVE_COMPARATOR

Smartphone app use

Intervention Type: BEHAVIORAL

Smartphone app use in the active arm

Standard of care

Standard of care

Group Type: OTHER

Standard of care

Intervention Type: BEHAVIORAL

Standard of care

Interventions

Smartphone app use

Smartphone app use in the active arm

Intervention Type: BEHAVIORAL

Standard of care

Standard of care

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• on SGLT-2 inhibitors, GLP-1 agonists, or thiazolidinediones
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lung-Yi Mak, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

The University of Hong Kong

Hong Kong, Select A State Or Province, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lung-Yi Mak, MD

Role: CONTACT

lungyi@hku.hk

852 22554704

Facility Contacts

Lung-Yi Mak, MD

Role: primary

lungyi@hku.hk

852 22554704

Wai-Kay Seto, MD

Role: backup

wkseto@hku.hk

852 22556979

Other Identifiers

HKU01

Identifier Type: -

Identifier Source: org_study_id