Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-04 @ 9:49 PM
Study NCT ID:
NCT05180760
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2021-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smartphone App for Non-alcoholic Fatty Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2021-12-01', 'studyFirstSubmitQcDate': '2022-01-04', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body weight', 'timeFrame': '12 months', 'description': 'Body weight of the participants will be measured at baseline and 12 months'}], 'secondaryOutcomes': [{'measure': 'Reduction in hepatic steatosis', 'timeFrame': '12 months', 'description': 'Hepatic steatosis will be quantified by transient elastography as expressed by controlled attenuation parameter (CAP)'}, {'measure': 'ALT normalization', 'timeFrame': '12 months', 'description': 'ALT as part of liver biochemistry will be measured at baseline and 12 months'}, {'measure': 'Reversal of sarcopenia', 'timeFrame': '12 months', 'description': 'Skeletal muscle mass will be quantified by bioelectrical analysis. Sarcopenia is common among subjects with NAFLD and is defined according to international guidelines.'}, {'measure': 'Changes in lipid profile', 'timeFrame': '12 months', 'description': 'Fasting lipid profile will be measured at baseline and 12 months'}, {'measure': 'Changes in glucose levels', 'timeFrame': '12 months', 'description': 'Fasting glucose levels will be measured at baseline and 12 months'}, {'measure': 'Visceral fat reduction', 'timeFrame': '12 months', 'description': 'Visceral fat will be assessed using bioelectrical analysis machine at baseline and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['non-alcoholic fatty liver disease', 'telemedicine', 'mobile health', 'self-management'], 'conditions': ['Non-Alcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': '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.\n\nClearly, 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.\n\nThis 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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* known NAFLD\n* able to read and understand Chinese\n* owns a compatible smartphone\n* without major cognitive impairment.\n\nExclusion Criteria:\n\n* on SGLT-2 inhibitors, GLP-1 agonists, or thiazolidinediones\n* patients with cirrhosis\n* patients who are pregnant\n* patients on special diet or with special dietary requirement (e.g. vegan, gluten free)\n* patients with heavy alcohol use (≥20 grams/ day for women or ≥30 grams/ day for men)\n* history of HCC or LT'}, 'identificationModule': {'nctId': 'NCT05180760', 'acronym': 'AppLiver', 'briefTitle': 'Smartphone App for Non-alcoholic Fatty Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Effectiveness of a Smartphone App in Promoting Weight Loss in Patients With Non-alcoholic Fatty Liver Disease: a Pilot Multi-centre Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HKU01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Smartphone app arm', 'description': 'Use the dedicated smartphone app for NAFLD patients', 'interventionNames': ['Behavioral: Smartphone app use']}, {'type': 'OTHER', 'label': 'Standard of care', 'description': 'Standard of care', 'interventionNames': ['Behavioral: Standard of care']}], 'interventions': [{'name': 'Smartphone app use', 'type': 'BEHAVIORAL', 'description': 'Smartphone app use in the active arm', 'armGroupLabels': ['Smartphone app arm']}, {'name': 'Standard of care', 'type': 'BEHAVIORAL', 'description': 'Standard of care', 'armGroupLabels': ['Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Hong Kong', 'state': 'Select A State Or Province', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lung-Yi Mak, MD', 'role': 'CONTACT', 'email': 'lungyi@hku.hk', 'phone': '852 22554704'}, {'name': 'Wai-Kay Seto, MD', 'role': 'CONTACT', 'email': 'wkseto@hku.hk', 'phone': '852 22556979'}, {'name': 'Lung-Yi Mak, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Lung-Yi Mak, MD', 'role': 'CONTACT', 'email': 'lungyi@hku.hk', 'phone': '852 22554704'}], 'overallOfficials': [{'name': 'Lung-Yi Mak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}