Not yet recruitingPHASE4INTERVENTIONAL

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

This study investigates if a digital app called Gro Health can improve liver health for people with a condition called MASLD that causes liver scarring. MASLD is common and can lead to serious liver problems, often linked to weight and metabolic issues. Healthy eating and exercise are important, but hard to stick to. The Gro Health app might provide personalised support. Researchers will compare people using the app to those receiving standard care over 12 months. They'll look at changes in liver scarring, weight, and overall wellbeing. This could show if digital tools offer a good way to help manage MASLD.

At a glance

Status

Not yet recruiting

Phase

PHASE4

Sponsor

St. George's Hospital, London

Enrolment target

100

Start

01 May 2025

Estimated completion

01 Sep 2027

Metabolic Dysfunction-Associated Steatotic Liver Disease

What is this study about?

You might have been told you have a liver condition called MASLD. This stands for Metabolic Dysfunction-Associated Steatotic Liver Disease. Essentially, it means you have too much fat in your liver, which can lead to inflammation and scarring, also known as fibrosis. This condition is often linked to things like being overweight or having diabetes. Over time, MASLD can cause severe liver damage if not managed.

Doctors know that a healthy diet and regular exercise are really important for improving MASLD. However, making these lifestyle changes and sticking to them can be tough for many people. This is where this research study comes in. It wants to find out if a digital app, called Gro Health, can make it easier to make these changes and improve your liver health.

The Gro Health app is designed to give you personalised support with your diet and exercise. It offers healthy recipes, helps you set activity goals, and lets you track what you eat. The study aims to see if using this app can reduce the amount of scarring in your liver and improve your overall health and quality of life.

Key takeaways

The study tests if a digital app can improve liver health for MASLD.
MASLD is a liver condition often linked to metabolic issues like obesity.
Healthy diet and exercise are key for managing MASLD.
The Gro Health app provides personalised support for diet and activity.
Participants will be compared to those receiving standard NHS care.
Researchers will check for reduced liver scarring and improved overall health.

Who may be eligible?

To join this study, you need to be an adult aged 18 or older and have a diagnosis of MASLD from a liver specialist. Your doctor will also need to have measured your liver stiffness, possibly using a special scan called a FibroScan, and it needs to be at a certain level (8 kPa or higher) to show significant scarring. You'll also need to have your own smartphone with internet access.

There are some reasons why you wouldn't be able to join. For example, if you drink more than 14 units of alcohol per week, have a very high body mass index (BMI) over 40, or if your liver disease is caused by other things like viral hepatitis or certain inherited conditions. You also can't take part if you're currently being investigated or treated for cancer, have had a recent heart attack, are pregnant or planning to be, or are taking certain medications that could affect the study results. If you're already using another weight loss programme or have had weight loss surgery, or have other serious illnesses, you might not be suitable.

Quick self-check

Are you 18 years old or over?
Have you been diagnosed with MASLD by a liver doctor?
Has your liver stiffness been measured at 8 kPa or higher?
Do you own a smartphone with internet access?
Do you drink less than 14 units of alcohol per week?
Are you not currently pregnant or planning a pregnancy?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll be randomly put into one of two groups. One group will use the Gro Health app, and the other will receive standard care, which means continuing with the advice your doctor normally gives you. The study will last for 12 months.

If you're in the app group, you'll use the Gro Health app to help you with your diet and exercise. This includes personalised calorie and activity goals, a food diary, and access to over 1,000 healthy Mediterranean recipes. You'll also get a smartwatch to help track your steps and physical activity. The researchers will be able to see how you're getting on with the app to offer encouragement.

Throughout the study, regardless of which group you're in, you'll have appointments to check your liver health, weight, body measurements, and blood tests. They'll also ask you about your quality of life. All these visits will be at a single study clinic.

Potential risks and benefits

Taking part in this study could potentially offer benefits, especially if you are in the group using the Gro Health app, as it might help you make lifestyle changes that improve your liver health and overall well-being. There are not many direct risks associated with using a digital app for diet and exercise advice. As with any study, there's always a chance the intervention might not work as expected, or that the lifestyle changes could be challenging to maintain. All medical procedures and tests involved in monitoring your health carry small, standard risks, which your doctor will explain. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

St George's University Hospitals NHS Foundation Trust
London, United Kingdom

Common questions

What is MASLD?

MASLD is a liver condition where too much fat builds up in your liver, often linked to being overweight or having diabetes. It can lead to liver scarring.

What is liver fibrosis?

Liver fibrosis is scarring in your liver. Too much scarring can make your liver less able to work properly over time.

What does the Gro Health app do?

The app helps you with a healthy diet and exercise, giving you personalised goals, recipes, and a food diary. It also tracks your activity using a smartwatch.

Will I get the Gro Health app if I join?

You might. Participants are randomly put into two groups: one uses the app, and the other receives standard care. You won't know which group you're in until after you join.

How long does the study last?

The study will last for 12 months, with regular check-ups to monitor your health and liver condition.

How to find out more

Caroline Gosson, MBBS

caroline.gosson@stgeorges.nhs.uk +4475902577755 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.