Metabolic Dysfunction-Associated Steatotic Liver DiseasePhase 4DEFIB-MASLDNCT06920316
Digital Diet and Exercise Intervention to Reduce Liver Fibrosis in Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
A Phase 4 study testing Gro Health digital application in people with Metabolic Dysfunction-Associated Steatotic Liver Disease, run by St. George's Hospital, London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- Gro Health digital application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2025to Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
St George's University Hospitals NHS Foundation Trust
London, London, SW170QT
Caroline Gosson, MBBS, +447590257755, caroline.gosson@stgeorges.nhs.uk
caroline.gosson@stgeorges.nhs.uk
About this study
Official title: Digital Diet and Exercise Intervention to Reduce Liver Fibrosis in Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD): A Pilot Randomised Controlled Trial
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:
Read more
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.
- Being tested
- Gro Health digital application
- Keywords
- Non-alcoholic Fatty Liver Disease, Fatty liver, Digital health
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gro Health digital applicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 6 and 12 months
Height in metres
Height in metres will be taken at baseline for the use in BMI calculation as stated for BMI outcome
Measured: baseline
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.
Measured: 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
Measured at baseline, 26 weeks and at the end of the intervention period using Withings smart scale
Measured: 6 and 12 months
Controlled Attenuation Parameter - To compare the effect of a digital application based lifestyle intervention to standard of care on CAP.
CAP is a measure of liver fat taken by Vibration Controlled Transient Elastography (also known as Fibroscan). Baseline CAP will be taken on day 0 using FibroScan machine by a trained operator who is not involved in the trial from all study participants. A reading will be taken at 26 weeks and at the end of the intervention period.
Measured: 6 and 12 months
Spleen stiffness measurement - To compare the effect of a digital application based lifestyle intervention to standard of care on SSM
Spleen stiffness measurement is measured by vibration controlled transient elastography (also known as Fibroscan) and indicates spleen scarring. Baseline SSM will be taken on day 0 using FibroScan machine by a trained operator who is not involved in the trial from all study participants. A reading will be taken at 26 weeks and at the end of the intervention period.
Measured: 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
Concentration of ALT, AST, HbA1c in blood samples will be taken on day 0, 26 weeks and at the end of the intervention period from all participants if not taken within the last 3 months
Measured: 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
Concentration of total cholesterol, LDL, HDL and triglycerides in blood samples will be taken on day 0, 26 weeks and at the end of the intervention period from all participants if not taken within the last 3 months.
Measured: 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
Baseline waist and hip circumference will be measured on day 0 using a tape measure in centimetres at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest as recommended by the WHO from all study participants. A measurement will be taken at 26 weeks and at the end of the intervention period.
Measured: 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
Baseline systolic blood pressure will be taken on day 0 from all study participants. A reading will be taken at 26 weeks and the end of the intervention period using a calibrated electronic sphygmomanometer.
Measured: 6 and 12 months
16. Echosens Agile 3+ score - composite score comprising LSM, ALT, AST, platelets, age, gender, diabetic status
Agile 3+ score will be calculated from baseline LSM, ALT, AST, platelets, age, gender and diabetic status and again calculated using the same parameters taken at 26 weeks and at the end of the intervention period.
Measured: 6 and 12 months
Health-related Quality of Life assessment - EuroQol EQ-5D-5L to compare the effect of a digital application based lifestyle intervention to standard of care on these
Health-related Quality of Life will be measured using the EuroQol EQ-5D-5L on day 0, 26 weeks and at the end of the intervention by all participants.
Measured: 6 and 12 months
Health-related Quality of Life assessment - Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis (CLDQ-NASH)) - To compare the effect of a digital application based lifestyle intervention to standard of care on these
Health-related Quality of Life will be measured using the Chronic Liver Disease Questionnaire for Non-alcoholic Steatohepatitis (CLDQ-NASH) on day 0, 26 weeks and at the end of the intervention by all participants.
Measured: 6 and 12 months
Hospital Anxiety and Depression Scale (HADS) - To compare the effect of a digital application based lifestyle intervention to standard of care on HADS
Hospital Anxiety and Depression Scale will be measured on day 0, 26 weeks and at the end of the intervention period by all participants
Measured: 6 and 12 months
Number of patients with improvement in liver stiffness measurement LSM - To compare the effect of a digital application based lifestyle intervention to standard of care on number of patients with improvement in LSM
The total number of patients with improvement in LSM in each group
Measured: 6 and 12 months
Liver stiffness measurement - same at primary outcome measure, but at 12 rather than 6 months
The primary outcome measure is change in liver stiffness measurement (LSM) at 6 months compared to baseline. This secondary outcome is that same measure but at 12 months to see if results are sustained. LSM is measured in kPa. 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.
Measured: 12 months
Assess the frequency of digital lifestyle application interaction
Gro Health can provide data of individual patient's application usage in the form of total number of 'application openings'. In the intervention group, we would assess whether the participants with more app openings have a greater improvement in their VCTE LSM.
Measured: 12 months
Assess the change in daily step count
In the intervention group, daily step count electronically recorded by compatible smartwatch. Measure mean weekly step count and how this changes over the 12 month period.
Measured: 12 months
Assess the change in amount and type of physical activity
In the intervention group, in addition to daily step count, physical activity can be manually logged by patient (time and date of activity, type of activity and activity duration). Measure weekly total minutes of physical activity and how this changes over the 12 month period.
Measured: 12 months
Assess the change in self-recorded weights
In the intervention group, we would assess the trend in weight loss over the 12 month period
Measured: 12 months
Assess the frequency of food diary usage
In the intervention group, we would assess how frequently participants log food and how this changes over time
Measured: 12 months
Assess the interaction with educational content
Percentage of total educational content reviewed by 12 months. Assess if there is a correlation between amount of educational content reviewed and if this leads to a greater reduction in VCTE LSM.
Measured: 12 months
Number of personalised messages sent to participant over 12 month period
In the intervention group, personalised messages will be sent at least monthly and also ad hoc. We would assess whether the number of messages correlates with change in VCTE LSM.
Measured: 12 months
Total minutes of telephone calls to participant over 12 month period
In the intervention group, telephone calls will be made to participants at 1 week and then ad hoc. We would assess whether the number of minutes correlates with change in VCTE LSM.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. George's Hospital, London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Gosson, St. George's Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920316
- Sponsor's protocol ID
- StGeorgesLondon
- Acronym
- DEFIB-MASLD
- Status last verified
- Apr 2025
- First submitted
- 29 Jan 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Diet and Exercise Intervention to Reduce Liver Fibrosis in Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD): A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06920316
- Acronym / sponsor ID
- DEFIB-MASLD / StGeorgesLondon
- Keywords
- Non-alcoholic Fatty Liver Disease, Fatty liver, Digital health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St. George's Hospital, LondonUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gro Health Application | Active comparator | Device: Gro Health digital applicationThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gro Health digital applicationThe 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 Application |
Primary outcome
The primary outcome measure is change in liver stiffness measurement at 6 months compared to baseline
Time frame: 6 months
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.
25 secondary outcomes
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
Health-related Quality of Life assessment - EuroQol EQ-5D-5L to compare the effect of a digital application based lifestyle intervention to standard of care on these
Time frame: 6 and 12 months
Health-related Quality of Life assessment - Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis (CLDQ-NASH)) - To compare the effect of a digital application based lifestyle intervention to standard of care on these
Time frame: 6 and 12 months
Hospital Anxiety and Depression Scale (HADS) - To compare the effect of a digital application based lifestyle intervention to standard of care on HADS
Time frame: 6 and 12 months
Number of patients with improvement in liver stiffness measurement LSM - To compare the effect of a digital application based lifestyle intervention to standard of care on number of patients with improvement in LSM
Time frame: 6 and 12 months
Liver stiffness measurement - same at primary outcome measure, but at 12 rather than 6 months
Time frame: 12 months
Assess the frequency of digital lifestyle application interaction
Time frame: 12 months
Assess the change in daily step count
Time frame: 12 months
Assess the change in amount and type of physical activity
Time frame: 12 months
Assess the change in self-recorded weights
Time frame: 12 months
Assess the frequency of food diary usage
Time frame: 12 months
Assess the interaction with educational content
Time frame: 12 months
Number of personalised messages sent to participant over 12 month period
Time frame: 12 months
Total minutes of telephone calls to participant over 12 month period
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gro Health digital application in people with Metabolic Dysfunction-Associated Steatotic Liver Disease, run by St. George's Hospital, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Gosson, MBBS (+4475902577755, caroline.gosson@stgeorges.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is change in liver stiffness measurement at 6 months compared to baseline (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.