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Active, Not Recruiting

NCT Number: NCT05180760

Smartphone App for Non-alcoholic Fatty Liver Disease

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong

Hong Kong, 0000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • newly initiated on sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists or thiazolidinediones or had recent dose adjustments (within 3 months)
  • 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

Treatment and study plan

Smartphone app use

Behavioral

Smartphone app use in the active arm

Standard of Care

Behavioral

Standard of care

Primary outcomes

  1. Change in body weight

    Time frame: 12 months

    Body weight of the participants will be measured at baseline and 12 months

Secondary outcomes

  1. Reduction in hepatic steatosis

    Time frame: 12 months

    Hepatic steatosis will be quantified by transient elastography as expressed by controlled attenuation parameter (CAP)

  2. ALT normalization

    Time frame: 12 months

    ALT as part of liver biochemistry will be measured at baseline and 12 months

  3. Reversal of sarcopenia

    Time frame: 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.

  4. Changes in lipid profile

    Time frame: 12 months

    Fasting lipid profile will be measured at baseline and 12 months

  5. Changes in glucose levels

    Time frame: 12 months

    Fasting glucose levels will be measured at baseline and 12 months

  6. Visceral fat reduction

    Time frame: 12 months

    Visceral fat will be assessed using bioelectrical analysis machine at baseline and 12 months

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study 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

Acronym: AppLiver

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 6, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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