Feasibility and acceptability of an evidence-informed digital intervention to support self-management in people with non-alcoholic fatty liver disease: protocol for a non-randomised feasibility study (VITALISE)

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) represents a spectrum of disease ranging from simple fatty liver to non-alcoholic steatohepatitis, cirrhosis, liver cancer and liver failure. NAFLD affects up to 30–40% of adults in Western countries and is directly linked to overweight and obesity. There are no approved drugs to specifically target NAFLD, therefore weight loss achieved through changes in dietary and physical activity behaviours is the recommended management approach. However, achieving and sustaining weight loss is challenging for patients with NAFLD. We developed a NAFLD-specific digital lifestyle intervention (VITALISE) to target changes in dietary and physical activity behaviours of patients with NAFLD to initiate weight loss and weight loss maintenance. This study aims to evaluate the feasibility and acceptability of VITALISE in a secondary care clinical setting. METHODS: A single-centre, one-arm, prospective design will be used to assess the feasibility and acceptability of recruitment, uptake, engagement and completion of VITALISE. Health-related outcomes will be assessed at baseline and 6-months. An interim measure of self-reported weight, physical activity and self-efficacy will be recorded at 12-weeks. Qualitative semi-structured interviews conducted at 6 months follow up will further explore acceptability and feasibility and fidelity of receipt and enactment. The study aims to recruit 35 patients with newly diagnosed NAFLD over a 6-month time period. Eligible patients will have continuous access to VITALISE and monthly tele-coaching support for 6 months prior to follow-up with a hepatologist. DISCUSSION: VITALISE offers access to evidence and theory-informed tailored dietary and physical activity support for patients with NAFLD. The intervention is designed for use by patients in their own time, outside of the hospital setting to overcome well documented challenges including attending additional appointments, and lack of time during routine appointments to adequately address lifestyle behaviour change. This feasibility study will determine the feasibility of VITALISE to support clinical care delivery. TRIAL REGISTRATION: ISRCTN12893503.