Clinical trial NCT06920316: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease
Keywords: Non-alcoholic Fatty Liver Disease
Fatty liver
Digital health
Lead sponsor: St. George's Hospital, London
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The primary outcome measure is change in liver stiffness measurement at 6 months compared to baseline
timeFrame: 6 months
Secondary outcomes:
measure: Weight in kilograms - To compare the effect of a digital application based lifestyle intervention to standard of care on weight
timeFrame: 6 and 12 months
measure: Percentage weight loss - To compare the effect of a digital application based lifestyle intervention to standard of care on percentage weight loss
timeFrame: 6 and 12 months
measure: Height in metres
timeFrame: baseline
measure: Body mass index - To compare the effect of a digital application based lifestyle intervention to standard of care on BMI
timeFrame: 6 and 12 months
measure: Body fat percentage - To compare the effect of a digital application based lifestyle intervention to standard of care on body fat percentage
timeFrame: 6 and 12 months
measure: Controlled Attenuation Parameter - To compare the effect of a digital application based lifestyle intervention to standard of care on CAP.
timeFrame: 6 and 12 months
measure: Spleen stiffness measurement - To compare the effect of a digital application based lifestyle intervention to standard of care on SSM
timeFrame: 6 and 12 months
measure: 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
timeFrame: 6 and 12 months
measure: 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
timeFrame: 6 and 12 months
measure: Waist and hip circumference - To compare the effect of a digital application based lifestyle intervention to standard of care on these measurements
timeFrame: 6 and 12 months
measure: Systolic blood pressure - To compare the effect of a digital application based lifestyle intervention to standard of care on blood pressure
timeFrame: 6 and 12 months
measure: 16. Echosens Agile 3+ score - composite score comprising LSM, ALT, AST, platelets, age, gender, diabetic status
timeFrame: 6 and 12 months
measure: 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
timeFrame: 6 and 12 months
measure: 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
timeFrame: 6 and 12 months
measure: Hospital Anxiety and Depression Scale (HADS) - To compare the effect of a digital application based lifestyle intervention to standard of care on HADS
timeFrame: 6 and 12 months
measure: 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
timeFrame: 6 and 12 months
measure: Liver stiffness measurement - same at primary outcome measure, but at 12 rather than 6 months
timeFrame: 12 months
measure: Assess the frequency of digital lifestyle application interaction
timeFrame: 12 months
measure: Assess the change in daily step count
timeFrame: 12 months
measure: Assess the change in amount and type of physical activity
timeFrame: 12 months
measure: Assess the change in self-recorded weights
timeFrame: 12 months
measure: Assess the frequency of food diary usage
timeFrame: 12 months
measure: Assess the interaction with educational content
timeFrame: 12 months
measure: Number of personalised messages sent to participant over 12 month period
timeFrame: 12 months
measure: Total minutes of telephone calls to participant over 12 month period
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
Study officials:
References: