DeFIB-MASLD Trial
Research type
Research Study
Full title
Digital Diet and Exercise Intervention to Reduce Liver Fibrosis in Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD): A Pilot Randomised Controlled Trial
IRAS ID
352682
Contact name
Daniel Forton
Contact email
Sponsor organisation
St George's University Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is a chronic liver condition caused by excessive fat accumulation in the liver, which can lead to liver scarring, failure or cancer. Affecting over 30% of the population, its prevalence is rising. Treatment focuses on a balanced diet, physical activity, and weight loss, but patients often lack the support to sustain these changes, leading to disease progression.
This trial at St George’s Hospital will compare standard care with a mobile app-based lifestyle intervention for patients with MASLD with fibrosis (liver scarring). Participants will be randomly assigned to either the current care group or the app intervention for 12 months. Liver stiffness will be measured at the start, 6 months, and end using FibroScan, a painless, ultrasound-like device. The app offers nutritional support, including a meal planner, recipes, food log, and calorie targets. It tracks daily steps from participants' smartwatches, provides exercise education and follow-along videos, and asks participants to monitor their weight. The research team will provide motivation through messages or phone calls.
We aim to see improved liver stiffness in the app group compared to the usual care group, indicating better liver health. We also hope for greater reductions in weight, body fat, blood pressure, cholesterol, and liver blood markers, along with improvements in quality of life. This trial is non-MHRA regulated, as the Gro Health app is CE-marked for MASLD, as well as several other conditions in adults.
REC name
London - Riverside Research Ethics Committee
REC reference
25/PR/0490
Date of REC Opinion
6 May 2025
REC opinion
Further Information Favourable Opinion