RecruitingNot ApplicableNCT05180760

Smartphone App for Non-alcoholic Fatty Liver Disease

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


Sponsor

The University of Hong Kong

Enrollment

260 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

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

Exclusion Criteria6

  • 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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Interventions

BEHAVIORALSmartphone app use

Smartphone app use in the active arm

BEHAVIORALStandard of care

Standard of care


Locations(1)

The University of Hong Kong

Hong Kong, Select A State Or Province, China

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NCT05180760


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