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

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.

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.

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.

Height in metres will be taken at baseline for the use in BMI calculation as stated for BMI outcome

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 at baseline, 26 weeks and at the end of the intervention period using Withings smart scale

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.

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.

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

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.

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.

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.

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.

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.

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.

Hospital Anxiety and Depression Scale will be measured on day 0, 26 weeks and at the end of the intervention period by all participants

The total number of patients with improvement in LSM in each group

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.

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.

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.

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.

In the intervention group, we would assess the trend in weight loss over the 12 month period

In the intervention group, we would assess how frequently participants log food and how this changes over time

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.

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.

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.