- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05180760
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
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lung-Yi Mak, MD
- Phone Number: 852 22554704
- Email: lungyi@hku.hk
Study Locations
-
-
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
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Principal Investigator:
- Lung-Yi Mak, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Smartphone app arm
Use the dedicated smartphone app for NAFLD patients
|
Smartphone app use in the active arm
|
Other: Standard of care
|
Standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body weight
Time Frame: 12 months
|
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
Time Frame: 12 months
|
Hepatic steatosis will be quantified by transient elastography as expressed by controlled attenuation parameter (CAP)
|
12 months
|
ALT normalization
Time Frame: 12 months
|
ALT as part of liver biochemistry will be measured at baseline and 12 months
|
12 months
|
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.
|
12 months
|
Changes in lipid profile
Time Frame: 12 months
|
Fasting lipid profile will be measured at baseline and 12 months
|
12 months
|
Changes in glucose levels
Time Frame: 12 months
|
Fasting glucose levels will be measured at baseline and 12 months
|
12 months
|
Visceral fat reduction
Time Frame: 12 months
|
Visceral fat will be assessed using bioelectrical analysis machine at baseline and 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lung-Yi Mak, MD, The University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HKU01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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