Randomised trial of lifestyle interventions for improving metabolic dysfunction-associated steatotic liver disease.
TL;DR
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.
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).