Clinical trial NCT05180760: Smartphone App for Non-alcoholic Fatty Liver Disease
Official title: Effectiveness of a Smartphone App in Promoting Weight Loss in Patients With Non-alcoholic Fatty Liver Disease: a Pilot Multi-centre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: non-alcoholic fatty liver disease
telemedicine
mobile health
self-management
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in body weight
timeFrame: 12 months
Secondary outcomes:
measure: Reduction in hepatic steatosis
timeFrame: 12 months
measure: ALT normalization
timeFrame: 12 months
measure: Reversal of sarcopenia
timeFrame: 12 months
measure: Changes in lipid profile
timeFrame: 12 months
measure: Changes in glucose levels
timeFrame: 12 months
measure: Visceral fat reduction
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The University of Hong Kong
state: Select A State Or Province
Study officials:
affiliation: The University of Hong Kong
name: Lung-Yi Mak, MD
role: PRINCIPAL_INVESTIGATOR
References: