Abstract
OBJECTIVE: Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common liver disease worldwide. Weight loss, achieved by changes to lifestyle behaviours, is the recommended management approach. However, patients find this challenging. A MASLD-specific digital behavioural intervention (interVention to promote lIfesTyle change in metabolic dysfunction-Associated steatotic LIver diseaSE, VITALISE) to target changes in dietary and physical activity behaviours was developed to support weight loss. This study assessed the feasibility and acceptability of delivering VITALISE in routine secondary care. METHODS: A single-centre, one-arm feasibility study recruited participants from November 2022 to May 2023. VITALISE included MASLD-specific education, provision of self-regulation tools (ie, goal setting, food monitoring, step tracking, weight monitoring) and monthly health coaching appointments by telephone. Patients had access to VITALISE for 6 months. Primary outcomes were feasibility (recruitment, uptake, engagement, adherence, and follow-up rates) and acceptability (patient views). Secondary outcomes were body weight, liver enzymes, liver stiffness, blood pressure, lipid profile, glycated hemoglobin (HbA1c), physical activity and patient activation. RESULTS: 35 patients (mean age 54 years; 69% male) with MASLD were recruited to VITALISE (recruitment rate 59%). Of the 35 enrolled, 83% activated their VITALISE account. Patient interviews supported acceptability. At 6 months, mean weight loss was 4.0 kg (3.5%) and alanine transaminase reduced by 27%. A decrease in daily sedentary time and an increase in light physical activity were observed. Self-reported leisure-time physical activity and patient activation increased from baseline to 6-month follow-up. CONCLUSIONS: VITALISE was feasible and acceptable to deliver in routine secondary care. Weight loss and improvements in lifestyle behaviours and liver enzymes were observed. Findings will inform intervention optimisation and future large-scale evaluation. TRIAL REGISTRATION NUMBER: ISRCTN12893503.