Abstract

Introduction: Cardiovascular disease is the most common cause of death among people with non-alcoholic fatty liver disease (NAFLD) and lifestyle changes can improve health outcomes. A NAFLD digital intervention was designed and here we report retention, engagement and satisfaction results in addition to the program's potential clinical impact on markers of liver- and cardiometabolic health. Hypothesis: We assessed the hypothesis that a digital intervention is feasible for individuals with metabolic derangements and NAFLD to improve cardiometabolic health. Methods: A prospective, open label, single arm, 12 week long study was conducted in Iceland.The intervention was delivered through the Sidekick app, with focus on disease education, low carbohydrate diet, increasing activity levels, reducing stress and healthy lifestyle coaching. Individuals with either BMI>30, metabolic syndrome or type 2 diabetes were screened for NAFLD with a FibroScan assessment. Other potential reasons for liver steatosis were excluded. Following recruitment and collection of demographic data, anthropometric and clinical measurements, MRI-PDFF for liver fat content, dual-energy X-ray absorptiometry for body composition and blood tests, were carried out at baseline and after 12 weeks. Primary outcomes were engagement and retention as measured in-app, and user satisfaction (mHealth App Usability Questionnaire); secondary outcomes were changes in weight, liver fat content and other cardiovascular risk factors. Results: In total, 38 individuals were included in the study and 34 (89%) completed the program (defined as being active 9/12 weeks). The median age was 59.5 [IQR 46.0,69.0] years and 23 (60.5%) were females. The median number of active days was 81 [IQR 45.8, 84.0] and the median user satisfaction score was 6.3 out of 7. The mean weight loss was 3.5 kg (SD=3.7) (p<0.001) with 5.0% (SD=7.0) reduction in fat mass (p<0.001), the average relative liver fat reduction was 19.3% (SD=23.9) (p<0.001). Systolic blood pressure reduced by 6.0 mmHg on average (SD=13.5) (p=0.009), diastolic blood pressure by 1.2 mmHg (SD=7.7) (p=0.357), triglyceride levels by 0.3 mmol/L (SD=0.6) (p=0.003) and waist circumference by 4.1 cm (SD=5.2) (p<0.001). In addition, participants who were active in-app at least 5 days per week on average achieved 3.8 kg (SD=3.7) (p<0.001) more weight loss and 19.3% (SD=23.9) (p=0.011) higher reduction in absolute liver fat percentage, compared to those who used the app less. Conclusion: This study suggests that a holistic digital intervention may improve liver-specific and cardiometabolic health in individuals with NAFLD, as indicated by the reduction in liver fat, systolic blood pressure and improvements in body composition. Together with the excellent program engagement, completion and satisfaction, this approach could provide a new tool to improve health outcomes in NAFLD.

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