NCT07007741Active, not recruiting
Digital Therapy for Fatty Liver Disease
A Randomised Controlled Trial Study of the Effect of Fatty Liver Data Analysis and Management Software on the Effectiveness of Intervention in Patients With Non-alcoholic Fatty Liver Disease
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
This study is a randomised controlled trial of the clinical application of the Fatty Liver Data Analysis and Intervention System (FLDAS) to compare the effectiveness of traditional lifestyle interventions in patients with fatty liver with digital therapies combining software and hardware devices; to validate the effectiveness of digital therapies in patients with fatty liver; and to evaluate the effectiveness of remote lifestyle (diet and exercise) interventions. Researchers conducted a randomised controlled trial to compare the effectiveness of a traditional lifestyle intervention for patients with fatty liver with a remote lifestyle (diet and exercise) intervention combining digital therapy software and hardware devices. When the effectiveness of this programme is validated, it could help clinicians improve the efficiency of lifestyle interventions for patients with fatty liver and address the growing need for primary care for patients with fatty liver as an innovative approach to disease intervention.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 141 (actual)
- First submitted
- 6 Mar 2025
- Start date
- 19 Nov 2022
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07007741
What you commit to
- Study type: Interventional
- Participants enrolled: 141
- From 19 Nov 2022 to the primary completion date, 1 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Inherited metabolic or autoimmune liver disease
- Drug/toxic/alcoholic/biliary liver injury, cirrhosis or any end-stage liver disease
- Hepatic or extrahepatic malignant tumours
Other
- Pregnant and lactating women
- Patients considered ineligible by the investigator's clinical judgment
Who the study is looking for
- NAFLD patient (CAP value \>248 (dB/m))
- Age 18-65 years old, 24kg/m2 ≤ BMI ≤ 35kg/m2
- Must be able to use smartphone
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xinhua Hospital Affiliated To Shanghai Jiao tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.