Smartphone App for Non-alcoholic Fatty Liver Disease

Not Applicable

Recruiting

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Behavioral: Smartphone app use; Behavioral: Standard of care

• Registration Number: NCT05180760
• Lead Sponsor: The University of Hong Kong

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-06
• Study Start: 2023-07-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smartphone app arm	Smartphone app use	Use the dedicated smartphone app for NAFLD patients
Standard of care	Standard of care	Standard of care

Primary Outcome Measures

Name	Time	Method
Change in body weight	12 months	Body weight of the participants will be measured at baseline and 12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The University of Hong Kong; 🇨🇳 Hong Kong, Select A State Or Province, China