Community-based lifestyle modification programme for non-alcoholic fatty liver disease: a randomized controlled trial

Abstract

Background & aims: Healthy lifestyle is the most important management of non-alcoholic fatty liver disease (NAFLD). This study aimed at assessing the efficacy of a community-based lifestyle modification programme in the remission of NAFLD.

Methods: This was a parallel group, superiority, randomized controlled trial. 154 adults with NAFLD identified during population screening were randomized to participate in a dietitian-led lifestyle modification programme at 2 community centres or receive usual care for 12 months. The primary outcome was remission of NAFLD at month 12 as evidenced by intrahepatic triglyceride content (IHTG) of less than 5% by proton-magnetic resonance spectroscopy.

Results: 74 patients in the intervention group and 71 patients in the control group completed all study assessments. In an intention-to-treat analysis of all 154 patients, 64% of the patients in the intervention group and 20% in the control group achieved remission of NAFLD (difference between groups 44%; 95% CI 30-58%; p<0.001). The mean (SD) changes in IHTG from baseline to month 12 were -6.7% (6.1%) in the intervention group and -2.1% (6.4%) in the control group (p<0.001). Body weight decreased by 5.6 (4.4) kg and 0.6 (2.5) kg in the two groups, respectively (p<0.001). While 97% of patients with weight loss of more than 10% had remission of NAFLD, 41% of those with weight loss of 3.0-4.9% could also achieve the primary outcome.

Conclusions: The community-based lifestyle modification programme is effective in reducing and normalizing liver fat in NAFLD patients.

Trial registration: ClinicalTrials.gov NCT00868933.

Keywords: (1)H-MRS; ALT; AST; BMI; GI; HDL; IHTG; LDL; Magnetic resonance spectroscopy; NAFLD; Non-alcoholic steatohepatitis; Obesity; Transient elastography; Weight loss; alanine aminotransferase; aspartate aminotransferase; body mass index; glycaemic index; high density lipoprotein; intrahepatic triglyceride content; low density lipoprotein; non-alcoholic fatty liver disease; proton-magnetic resonance spectroscopy.