Abstract / Summary
Abstract Background and aims Lifestyle modification is the cornerstone of treatment for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). To date, no published randomised controlled trials (RCTs) have provided a direct, head-to-head comparison between mobile (m)-health and structured, human-led dietitian coaching in the management of MASLD. Methods In a single-centre, 12-month RCT, participants ( n =297) were randomised into three arms: (1) minimal intervention therapy (MIT) ( n =102), (2) lifestyle coaching ( n =97), and 3) m-health (n=98). Steatosis was measured using the controlled-attenuation parameter (CAP™), steatohepatitis by aspartate aminotransferase (AST), and fibrosis by vibration-controlled transient elastography (VCTE™). Results Across all three study arms, an equally ( p =0.998) significant reduction in CAP™ was observed. The mean CAP™ change was −23.94 dB/m (95% CI [− 36.70; −11.17], p <0.001) for the MIT group, −23.66 dB/m (95% CI [− 36.08;−11.23], p <0.001) for the lifestyle coaching group, and −21.96 dB/m (95% CI: [− 35.77;−8.15], p =0.002) for the m-health group. Over the 12-month period, guidance via m-health resulted in a significant decrease in mean serum AST levels (− 2.81 U/L (95% CI [− 5.06;−0.57], p =0.014). None of the intervention methods had a significant effect on fibrosis. Conclusions This study shows that all three lifestyle-guidance modalities produced comparable, significant reductions in liver steatosis over 12 months, with no significant differences between groups and no observed changes in liver stiffness. These findings support m-health as a feasible, scalable alternative in MASLD management, though multi-centre validation is warranted to confirm these outcomes. Trail registrations (clinicaltrials.gov NCT05792488).