Digital Diet and Exercise Intervention to Reduce Liver Fibrosis in Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD): A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary outcome measure is change in liver stiffness measurement at 6 months compared to baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Alcohol consumption >14 units/week
- •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
研究组 & 干预措施
Gro Health Application
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.
干预措施: Gro Health digital application (Device)
Standard of Care
If randomised to this arm, participants will not receiving any additional intervention beyond their usual clinical care for their condition.
结局指标
主要结局
The primary outcome measure is change in liver stiffness measurement at 6 months compared to baseline
时间窗: 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.
次要结局
- 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)
- Controlled Attenuation Parameter - To compare the effect of a digital application based lifestyle intervention to standard of care on CAP.(6 and 12 months)
- Height in metres(baseline)
- 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)
- Spleen stiffness measurement - To compare the effect of a digital application based lifestyle intervention to standard of care on SSM(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(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(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(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(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(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(6 and 12 months)
- Number of personalised messages sent to participant over 12 month period(12 months)
- 16. Echosens Agile 3+ score - composite score comprising LSM, ALT, AST, platelets, age, gender, diabetic status(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(6 and 12 months)
- Total minutes of telephone calls to participant over 12 month period(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(6 and 12 months)
- Liver stiffness measurement - same at primary outcome measure, but at 12 rather than 6 months(12 months)
- Assess the frequency of digital lifestyle application interaction(12 months)
- Assess the change in daily step count(12 months)
- Assess the change in amount and type of physical activity(12 months)
- Assess the change in self-recorded weights(12 months)
- Assess the frequency of food diary usage(12 months)
- Assess the interaction with educational content(12 months)
研究者
Caroline Gosson
Principal Investigator, Hepatology Clinical Research Fellow
St. George's Hospital, London