Lifestyle intervention is the mainstay therapy for Non-Alcoholic Fatty Liver Disease (NAFLD). We aimed to assess the efficacy of an intensive (9 contact points in 6 months) weight-loss intervention among patients with obesity (BMI 25–39.9 kg/m 2) and NAFLD in north India.
A total of 140 patients (18–60 years) with obesity and NAFLD were randomized into intervention ( n = 70) and control ( n = 70) groups, at a tertiary-care hospital. Weight, anthropometric parameters, Controlled Attenuation Parameter (CAP), Liver Stiffness Measurement (LSM), liver enzymes, grade of fatty liver and HOMA-IR were measured at baseline (T 0) and 6 months (T 6). There was a high drop-out, exacerbated by the Covid-19 pandemic. Completers comprised of 59 participants ( n = 30 intervention, n = 29 control). Intention to treat analysis was done.
At T 6, ALT normalized in significantly higher ( p = 0.03) number of cases in the intervention arm (66.7%) versus control arm (18.2%). No significant improvement was seen in other metabolic, ultrasound or anthropometric outcomes. Weight ( p < 0.001), AST ( p = 0.01), ALT ( p = 0.02), body fat% ( p < 0.001), WC ( p < 0.001) and CAP ( p < 0.001) significantly improved within the intervention arm along with a trend of improvement in steatosis and HOMA-IR. Control group showed significant decrease in weight ( p < 0.001), WC ( p < 0.001) and CAP ( p = 0.02). Twice the number of patients in intervention arm (46.7%) lost ≥5% weight, compared to control arm (24.1%) ( p = 0.07).