Hepatology international · 2026
Randomised trial of lifestyle interventions for improving metabolic dysfunction-associated steatotic liver disease.
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Robaeys Wouter, Heyens Leen Jm, Bruckers Liesbeth, Penders Joris, Struyve Mathieu, Koek Ger H, Francque Sven Ma, Robaeys Geert Kmm
Аннотация
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).
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).