Study Title: Digital Diet and Exercise Intervention to Reduce Liver Fibrosis in Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD): A Randomized Controlled Trial (D-FIB-MASLD)
Objective:
This study aims to assess whether a digital application called Gro Health can help patients with MASLD and significant liver fibrosis reduce their liver stiffness. Liver stiffness is a measure of liver health and fibrosis. The study will also investigate the impact of this intervention on weight, body measurements, liver health markers, and overall quality of life.
Background:
MASLD is a liver condition linked to metabolic issues such as obesity and diabetes. It is a common cause of liver-related complications and can lead to severe liver damage. Lifestyle changes, like improved diet and exercise, are key to managing MASLD, but achieving these changes can be challenging for many patients. Digital tools like the Gro Health app may provide personalized and accessible support to improve outcomes.
Study Design:
This is a randomized controlled trial involving 100 participants with MASLD and significant fibrosis. Participants will be assigned to either the intervention group (using the Gro Health app) or a control group (receiving standard care). The study will take place at a single site over 12 months.
Intervention:
Participants in the intervention group will use the Gro Health app, which offers personalized calorie and activity goals, a food diary, over 1,000 Mediterranean diet recipes, and educational resources. They will also receive a smartwatch to track steps and physical activity. The app includes a feature allowing researchers to monitor participants' engagement and provide encouragement.
Eligibility:
Adults aged 18 or older with a diagnosis of MASLD and a liver stiffness measurement of 8 kPa or higher are eligible. Key exclusions include alcohol consumption over 14 units/week, a BMI over 40, or certain other liver diseases or medications.
Outcomes:
The primary outcome is a reduction in liver stiffness after six months. Secondary outcomes include changes in weight, BMI, body fat percentage, liver enzymes, cholesterol, and quality of life. Additional data on app usage, physical activity, and dietary habits will also be collected for the intervention group.
Potential Impact:
If successful, this study will provide evidence that digital tools can help improve liver health and overall well-being in patients with MASLD, offering a scalable solution for healthcare systems.
Adults 18 years and over
Diagnosis of MASLD made by a hepatologist
Vibration-Controlled Transient Elastography (VCTE) (FibroScan) liver stiffness measurement (LSM) 8 kPa and above
Able to provide written consent
Alcohol consumption >14 units/week
BMI >40
Liver disease due to: Alcohol including MASLD with increased alcohol intake (MetALD), Any viral hepatitis, Autoimmune and cholestatic aetiologies including, but not limited to, primary biliary cholangitis and primary sclerosing cholangitis, Hereditary aetiologies including, but not limited to, haemachromatosis, Wilson's disease, alpha-1-antitrypsin deficiency
Currently under investigation for cancer or receiving treatment for active cancer
Parallel
Gro Health digital application
DeviceThe Gro Health digital application is a personalised treatment platform proven to support sustainable weight loss. It is non-MHRA regulated as MASLD is within the device's UKCA/CE UKNI/CE marked indication. Gro Health reports 7% weight loss at 52 weeks in patients with Type 2 Diabetes Mellitus. We can set up the application so patients follow a Mediterranean diet. Over 1000 recipes of different cuisines will be available, along with weekly diet plans and shopping lists. Based on the patient's body mass index, daily calories and macronutrient targets will be calculated in line with the Mediterranean diet. Aerobic exercise can be tracked by daily step count linked by compatible smartwatches and smartphones. Physical activity can also be logged manually. Gro Health provides educational videos on aerobic and resistance exercise, along with 'follow along' videos of exercises for patients. These videos range from ones for beginners to those who have more experience with exercise.
The primary outcome measure is change in liver stiffness measurement at 6 months compared to baseline
The primary outcome measure is change in liver stiffness measurement (LSM) at 6 months compared to baseline. LSM is measured in kPa. Vibration controlled transient elastography (VCTE) has been validated as a measure of fibrosis across a wide spectrum of chronic liver diseases including MASLD. Whilst liver histology remains the gold standard for fibrosis staging, and magnetic resonance imaging and elastography for non-invasive hepatic lipid quantification and fibrosis respectively, both techniques are largely limited by being time consuming and expensive. VCTE provides multiple advantages of low cost, short procedure time, immediate result availability, good reproducibility and the ability to be performed in an outpatient setting. Studies have shown that LSM has good accuracy for liver-related events and mortality. Change in LSM has been shown to correlate with the risk of liver-related events and death.
Weight in kilograms - To compare the effect of a digital application based lifestyle intervention to standard of care on weight
Baseline weight in kilograms will be taken at day 0 on calibrated hospital scales in clinic from all study participants. A formal weight will be taken at all hospital clinic appointments and at 26 weeks and at the end of the intervention period. Only weights taken on the calibrated hospital scales will be used for analysis.
Percentage weight loss - To compare the effect of a digital application based lifestyle intervention to standard of care on percentage weight loss
Baseline weight in kilograms will be taken at day 0 on calibrated hospital scales in clinic from all study participants. A formal weight will be taken at all hospital clinic appointments and at 26 weeks and at the end of the intervention period. Only weights taken on the calibrated hospital scales will be used for analysis.
Height in metres
Height in metres will be taken at baseline for the use in BMI calculation as stated for BMI outcome
Body mass index - To compare the effect of a digital application based lifestyle intervention to standard of care on BMI
Baseline weight in kilograms will be taken at day 0 on calibrated hospital scales in clinic from all study participants. Baseline height will be taken at day 0 only. A formal weight will be taken at all hospital clinic appointments and at 26 weeks and at the end of the intervention period. Only weights taken on the calibrated hospital scales will be used for analysis.
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