Effect of intensive weight-loss intervention on metabolic, ultrasound and anthropometric parameters among patients with obesity and non-alcoholic fatty liver disease: an RCT.

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/m2) 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 (T0) and 6 months (T6). 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 T6, 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.

Development and validation of a questionnaire to evaluate the impact of COVID-19 on lifestyle-related behaviours: eating habits, activity and sleep behaviour.

OBJECTIVE: This study was conducted to develop and validate a questionnaire to assess the impact of COVID-19 pandemic on lifestyle-related behaviour related to eating, activity and sleep pattern. DESIGN: Indexed study used a mixed method design. Phase I employed qualitative methods for development of questionnaire including literature review, focus group discussion, expert evaluation and pre-testing. Phase II used quantitative methods for establishing construct validity of the questionnaire via parallel factor analysis. PARTICIPANTS: Phase 1 involved participation of experts from different fields (Departments of Medicine, Nutrition and Clinical Psychology) and general adult population. For phase II, data were collected from 124 adult respondents (female = 57·26 %); mean age (36 ± 14·8 years) residing in an urban setting. RESULTS: The questionnaire consisted of three sections: (A) socio-demographic and anthropometric parameters, (B) twenty-four items each for investigating the changes in eating, activity and sleep behaviour before v. during COVID-19, (C) six items assessing COVID-19 specific reasons for lifestyle change. The Cronbach's α value of the questionnaire is 0·83 suggesting its good internal consistency. CONCLUSIONS: This appears to be a valid tool to assess the impact of COVID-19 on lifestyle-related behaviours with potential utility for public health researchers to identify these changes at community level and develop strategies to reinforce corrective behaviours.