Nonalcoholic Fatty Liver, Steatohepatitis, Nonalcoholic
Conditions
Brief summary
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.
Interventions
OTHERSoftware Group
Download the "Fatty Liver Data Analysis and Management Software", register and update your profile, connect to a scale, and associate with a researcher and dietitian. Upload meal charts and weight and body fat data every day, adjust recipes according to the patient's exercise and diet every week, and customise one-on-one Q\&A according to the patient's uploaded photos every day. After enrolment, w12 and w24 were required to follow-up to complete relevant examinations and scales and collect data.
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* NAFLD patient (CAP value \>248 (dB/m)) * Age 18-65 years old, 24kg/m2 ≤ BMI ≤ 35kg/m2 * Must be able to use smartphone
Exclusion criteria
* Inherited metabolic or autoimmune liver disease * Drug/toxic/alcoholic/biliary liver injury, cirrhosis or any end-stage liver disease * Hepatic or extrahepatic malignant tumours * Pregnant and lactating women * Patients considered ineligible by the investigator's clinical judgment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduced body weight rate | Week 12 & Week 24 | The Fatty Liver Data Analysis and Intervention Software (FLADIS) was used to assist clinicians with remote data monitoring and follow-up of NAFLD patients, as well as lifestyle intervention guidance and follow-up management, and to evaluate the effectiveness of the FLADIS intervention on the degree of weight loss in patients with NAFLD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decreased CAP Value (Indicating Reduced Liver Fat) | Week 12 & Week 24 | The Fatty Liver Data Analysis and Intervention Software (FLADlS) was used to assist clinicians with remote data monitoring and follow-up of NAFLD patients,as well as lifestye intervention guidance and follow-up management, and to evaluate the effectiveness of the FLADIS intervention in restoring NAFLD patients' Controlled Attenuation Parameter (CAP) values to normal ranges (CAP \< 248 dB/m) |
Countries
China
Outcome results
None listed