![]() The aim of the study is to evaluate the feasibility and acceptability of VITALISE in the clinical setting within secondary care. Together these enable patients to plan and track changes, and develop strategies to overcome any barriers encountered, supported by lifestyle coaches. It provides guideline-recommended structured education and self-regulation tools to facilitate supported self-management. VITALISE was co-designed with patients and healthcare professionals (HCPs) and addresses the pressing need for a behaviour change programme for people with NAFLD, targeting dietary and physical activity behaviours to initiate weight loss and weight loss maintenance. This process enables replication in terms of development and delivery of interventions and facilitates intervention optimisation and robust evaluation. It provides a step-by-step account of the translation of theory- and evidence-based behaviour change techniques into intervention components, which explicitly target theoretical determinants of behaviour and behaviour change. Intervention Mapping provides a systematic approach to developing theory- and evidence-informed interventions that integrates the requirements of the target population. We systematically developed an evidence and theory-informed NAFLD-specific digital lifestyle intervention using Intervention Mapping -VITALISE (inter Vention to promote l Ifes Tyle change in non- Alcoholic fatty LIver disea SE). However, people with NAFLD find achieving sustained weight loss a significant challenge, and clinicians struggle to support patients with NAFLD due to a lack of specific training, interventions, and referral pathways. Evidence-based clinical guidelines for the management of NAFLD state the importance of lifestyle behaviour change in patients with NAFLD, regardless of disease severity. ![]() Weight loss, achieved through change in dietary and physical activity behaviours is the recommended treatment for NAFLD, which can reduce liver fat, inflammation and fibrosis. Currently, there are no approved drugs to specifically target or treat NAFLD. NAFLD is directly linked to being overweight or obese, usually caused by chronic excess calorie consumption and a lack of physical activity and exercise. ![]() Approximately 40% of patients with NAFLD will develop progressive liver fibrosis and ultimately, 5–11% will develop end-stage liver disease. It represents a spectrum of liver disease ranging from simple fatty liver through to non-alcoholic steatohepatitis (NASH – liver inflammation), life threatening cirrhosis, liver cancer and liver failure, and has become a common cause of liver transplant. Non-alcoholic fatty liver disease (NAFLD) affects up to 30–40% of adults in Western countries and is the most common liver condition worldwide. This feasibility study will determine the feasibility of VITALISE to support clinical care delivery. 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. VITALISE offers access to evidence and theory-informed tailored dietary and physical activity support for patients with NAFLD. Eligible patients will have continuous access to VITALISE and monthly tele-coaching support for 6 months prior to follow-up with a hepatologist. The study aims to recruit 35 patients with newly diagnosed NAFLD over a 6-month time period. Qualitative semi-structured interviews conducted at 6 months follow up will further explore acceptability and feasibility and fidelity of receipt and enactment. An interim measure of self-reported weight, physical activity and self-efficacy will be recorded at 12-weeks. Health-related outcomes will be assessed at baseline and 6-months. MethodsĪ single-centre, one-arm, prospective design will be used to assess the feasibility and acceptability of recruitment, uptake, engagement and completion of VITALISE. This study aims to evaluate the feasibility and acceptability of VITALISE in a secondary care clinical setting. 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. However, achieving and sustaining weight loss is challenging for patients with NAFLD. 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. ![]() NAFLD affects up to 30–40% of adults in Western countries and is directly linked to overweight and obesity. 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.
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