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

NCT06920316 | Not Yet Recruiting Phase 4

• 1 other identifier: StGeorgesLondon
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

Non-alcoholic Fatty Liver Disease; Fatty liver; Digital health

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (25)

• Weight in kilograms - To compare the effect of a digital application based lifestyle intervention to standard of care on weight

  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

  6 and 12 months

• Height in metres

  baseline

• Body mass index - To compare the effect of a digital application based lifestyle intervention to standard of care on BMI

  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

  6 and 12 months

Study Arms (2)

Gro Health Application

ACTIVE COMPARATOR

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 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.

Device: Gro Health digital application

Standard of Care

NO INTERVENTION

If randomised to this arm, participants will not receiving any additional intervention beyond their usual clinical care for their condition.

Interventions

Gro Health digital application DEVICE

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 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.

Gro Health Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. George's Hospital, London: lead

Study Sites (1)

St George's University Hospitals NHS Foundation Trust

London, London, SW170QT, United Kingdom

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Central Study Contacts

Caroline Gosson, MBBS

CONTACT

+4475902577755; caroline.gosson@stgeorges.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Hepatology Clinical Research Fellow

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: April 9, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)