Smartphone App for Non-alcoholic Fatty Liver Disease (AppLiver)

Effectiveness of a Smartphone App in Promoting Weight Loss in Patients With Non-alcoholic Fatty Liver Disease: a Pilot Multi-centre Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Behavioral: Smartphone app use; Behavioral: Standard of care

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.

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lung-Yi Mak, MD; Phone Number: 852 22554704; Email: lungyi@hku.hk

Study Locations

• China
  • Select A State Or Province
    • Hong Kong, Select A State Or Province, China, 0000
      • Recruiting
      • The University of Hong Kong
      • Contact: Lung-Yi Mak, MD; Phone Number: 852 22554704; Email: lungyi@hku.hk
      • Contact: Wai-Kay Seto, MD; Phone Number: 852 22556979; Email: wkseto@hku.hk
      • Principal Investigator: Lung-Yi Mak, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Smartphone app arm; Use the dedicated smartphone app for NAFLD patients	Behavioral: Smartphone app use; Smartphone app use in the active arm
Other: Standard of care	Behavioral: Standard of care; Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Body weight of the participants will be measured at baseline and 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in hepatic steatosis	Hepatic steatosis will be quantified by transient elastography as expressed by controlled attenuation parameter (CAP)	12 months
ALT normalization	ALT as part of liver biochemistry will be measured at baseline and 12 months	12 months
Reversal of sarcopenia	Skeletal muscle mass will be quantified by bioelectrical analysis. Sarcopenia is common among subjects with NAFLD and is defined according to international guidelines.	12 months
Changes in lipid profile	Fasting lipid profile will be measured at baseline and 12 months	12 months
Changes in glucose levels	Fasting glucose levels will be measured at baseline and 12 months	12 months
Visceral fat reduction	Visceral fat will be assessed using bioelectrical analysis machine at baseline and 12 months	12 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Lung-Yi Mak, MD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: mobile health; self-management; telemedicine; non-alcoholic fatty liver disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: HKU01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No