Digital Diet and Exercise Intervention to Reduce Liver Fibrosis in Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)

Official title

Digital Diet and Exercise Intervention to Reduce Liver Fibrosis in Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD): A Pilot Randomised Controlled Trial

Overview

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.

Interventions

• Device Gro Health digital application
  The 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 bo

Primary outcome measures

• The primary outcome measure is change in liver stiffness measurement at 6 months compared to baseline [Time frame: 6 months]

Secondary outcome measures (12)

• Weight in kilograms - To compare the effect of a digital application based lifestyle intervention to standard of care on weight [Time frame: 6 and 12 months]
• Percentage weight loss - To compare the effect of a digital application based lifestyle intervention to standard of care on percentage weight loss [Time frame: 6 and 12 months]
• Height in metres [Time frame: baseline]
• Body mass index - To compare the effect of a digital application based lifestyle intervention to standard of care on BMI [Time frame: 6 and 12 months]
• Body fat percentage - To compare the effect of a digital application based lifestyle intervention to standard of care on body fat percentage [Time frame: 6 and 12 months]
• Controlled Attenuation Parameter - To compare the effect of a digital application based lifestyle intervention to standard of care on CAP. [Time frame: 6 and 12 months]
• Spleen stiffness measurement - To compare the effect of a digital application based lifestyle intervention to standard of care on SSM [Time frame: 6 and 12 months]
• To compare the effect of a digital application based lifestyle intervention to standard of care on the following blood parameters: alanine transaminase ALT, aspartate aminotransferase AST, HbA1c [Time frame: 6 and 12 months]
• To compare the effect of a digital application based lifestyle intervention to standard of care on the following blood parameters: total cholesterol, low-density lipoprotein cholesterol LDL, high-density lipoprotein cholesterol HDL, triglycerides [Time frame: 6 and 12 months]
• Waist and hip circumference - To compare the effect of a digital application based lifestyle intervention to standard of care on these measurements [Time frame: 6 and 12 months]
• Systolic blood pressure - To compare the effect of a digital application based lifestyle intervention to standard of care on blood pressure [Time frame: 6 and 12 months]
• 16. Echosens Agile 3+ score - composite score comprising LSM, ALT, AST, platelets, age, gender, diabetic status [Time frame: 6 and 12 months]

Eligibility criteria

Inclusion criteria

• 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
• Own a smartphone with data plan

Exclusion criteria

• 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
• Myocardial infarction within last 6 months or uncontrolled cardiovascular disease
• Pregnant or planning
• Currently or due to be taking any of the following drugs: GLP-1/GIP agonists, Systemic high dose corticosteroids for >6 weeks, Tamoxifen, Amiodarone, Methotrexate, Lomitapide, Valproate, Irinotecan, 5-Fluoruracil
• Currently using or enrolled in any other lifestyle intervention application or weight loss programme
• Undergone or due to undergo bariatric surgery including bariatric endoscopic procedures
• Any other intercurrent illness that is either life-threatening or of clinical significance such that it might limit compliance with study procedures, in the Investigator's opinion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

• St George's University Hospitals NHS Foundation Trust — London

Identifiers

NCT: NCT06920316 · StGeorgesLondon

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗