VITALISE
Research type
Research Study
Full title
Assessing the feasibility of an evidence-informed digital intervention to support self-management in people with non-alcoholic fatty liver disease (VITALISE- interVention to promote lIfesTyle change in non-Alcoholic fatty LIver diseaSE)
IRAS ID
313662
Contact name
Kate Hallsworth
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust/Newcastle University
ISRCTN Number
ISRCTN12893503
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Non-alcoholic fatty liver disease (NAFLD) affects up to 1-in-3 adults in the UK. 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. Overall, approximately 40% of patients with NAFLD will develop progressive liver fibrosis and ultimately, 5-11% of these develop end-stage liver disease. NAFLD is directly linked to being overweight or obese, usually caused by chronic excess calorie consumption and a lack of physical activity and exercise. Currently, there are no approved drugs to specifically target or treat NAFLD. As such, the recommended treatment is lifestyle behaviour change to initiate and maintain weight loss to improve liver health. However, people with NAFLD find weight loss and weight loss maintenance a significant challenge, and clinicians struggle to support patients with NAFLD due to a lack of specific training, interventions and referral pathways.
Work which has led to the current project: We systematically developed an evidence and theory-informed NAFLD-specific digital lifestyle intervention (VITALISE)(Hallsworth et al. J Med Internet Res 2021). VITALISE addresses the pressing need for a behaviour change programme for people with NAFLD, targeting diet and physical activity to initiate weight loss and weight loss maintenance. It provides guideline recommended structured education and self-regulation tools. Together these enable patients to plan and track changes, and overcome any barriers encountered, supported by tele-coaches.
The aim of the proposed study is to evaluate the feasibility and acceptability of VITALISE in the clinical setting. This feasibility trial will not include formal hypothesis testing because it is not powered to detect clinically meaningful changes in outcomes. The main aim of the feasibility study is to gain insight into whether patients find VITALISE acceptable: can/do they use it?; how can usability be improved?; how can inclusivity be improved? And whether it is feasible to deliver the intervention within routine clinical care.
Lay summary of study results: 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 (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 was conducted. VITALISE included MASLD-specific education, provision of self-regulation tools (i.e. 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, 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 overall acceptability. At 6-months, mean weight loss was 4.0kg (3.5%) and ALT reduced by 27%. A decrease in daily sedentary time and increase in light physical activity were observed. Self-reported 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.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0090
Date of REC Opinion
31 May 2022
REC opinion
Favourable Opinion