Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSION: The intensive weight-loss intervention was not effective in improving the treatment outcomes among patients with obesity and NAFLD. However, given the potential of our intervention, we recommend larger trials with more intensive weight-loss interventions.