VITALISE - intervention to promote lifestyle change in non-alcoholic fatty liver disease
| ISRCTN | ISRCTN12893503 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12893503 |
| IRAS number | 313662 |
| Secondary identifying numbers | IRAS 313662, CPMS 52889 |
- Submission date
- 02/08/2022
- Registration date
- 30/08/2022
- Last edited
- 02/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Non-alcoholic fatty liver disease (NAFLD) affects up to 1-in-3 adults in the UK and is closely linked with overweight or obesity. Currently, there are no licenced drug treatments for NAFLD. The main treatment is a lifestyle change with weight loss being central to improving liver health. Despite the positive effect of lifestyle change on liver health, structured lifestyle programmes for are not routinely used/available in clinical care.
Who can participate?
Adults with NAFLD
What does the study involve?
We have developed an evidence-based intervention targeting lifestyle change for patients with NAFLD (VITALISE- interVention to promote lIfesTyle change in non-Alcoholic fatty LIver diseaSE). The developmental process involved significant patient input and received positive feedback via usability testing. However, VITALISE has not yet been used/tested as part of routine clinical care.
Our study aims to assess the feasibility of using VITALISE in the clinical setting. Patients recruited to the study will have access to VITALISE for 6-months and will be supported by tele-coaches to set personalised goals linked to weight loss/dietary change/physical activity. We will collect data on whether patients find VITALISE acceptable: can/do they use it?; how we can improve usability; and how we can improve inclusivity. We will also collect preliminary data on clinical outcome measures collected as part of routine care.
This will be the first study to provide evidence for the feasibility of using VITALISE in routine clinical care for patients with NAFLD. We will use this data to inform a future funding application to allow a larger-scale evaluation of VITALISE in the NHS.
What are the possible benefits and risks of participating?
There are many potential benefits to accessing the VITALISE programme. This includes access to credible, up-to-date information on what NAFLD is and how to manage it through lifestyle change. The information included in the programme is based on clinical guidelines and the tele-coaches have been trained specifically to support people with NAFLD to make informed, personalised changes to their daily lives to improve their liver health. We hope that the programme will help people with NAFLD to lose weight and become more physically active.
The possible risks will include assessments on the same day as your routine visit to the hospital as this will extend the length of your appointment by up to 30 minutes. Accessing the VITALISE programme will take up some of your time but it will be up to you when you choose to access it and you can arrange the coaching appointments at a time that suits you.
Where is the study run from?
Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust (United Kingdom)
When is the study starting and how long is it expected to run for?
January 2022 to March 2024
Who is funding the study?
Newcastle upon Tyne Hospitals NHS Charity (United Kingdom)
Who is the main contact?
Dr kate Hallsworth (United Kingdom)
kate.hallsworth@ncl.ac.uk
Contact information
Principal Investigator
4th Floor William Leech Building
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
 ORCID ID |
0000-0002-1860-6970 |
|---|---|
| Phone | +44 (0)7967110263 |
| kate.hallsworth@ncl.ac.uk |
Study information
| Study design | Single-centre one-arm prospective-design feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | 42168 VITALISE PIS V4.0 clean.pdf |
| Scientific 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) |
| Study acronym | VITALISE |
| Study objectives | 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. In line with NIHR and CONSORT guidance for feasibility studies, the primary objectives are to determine recruitment, retention and attrition rates, intervention uptake, engagement, adherence, and follow-up rates and to test the robustness of our data collection procedures. We will collect data on usability and individual patient views on VITALISE via semi-structured interviews. Importantly, we will look at the demographics of patients who participate versus those who decline. We will seek information from those who decline to explore ways in which these barriers can be overcome. The secondary objective is to determine whether acceptability and feasibility lead to changes in outcomes including body weight, HbA1c, liver enzymes, liver stiffness, blood pressure and lipid profile (all measured as part of standard care using the NuTH NAFLD Care Bundle). These preliminary data will provide some indication of whether the intervention could be effective as part of routine clinical care. |
| Ethics approval(s) | Approved 30/05/2022, North East - Tyne & Wear South Research Ethics Committee (Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 (0)2071048306; tyneandwearsouth.rec@hra.nhs.uk), ref: 22/NE/0090 |
| Health condition(s) or problem(s) studied | Non-alcoholic fatty liver disease (NAFLD) |
| Intervention | Patients will be given a personal login for the VITALISE programme and will have continuous access for a 6-month time period prior to their follow-up appointment with a hepatologist. Patients will be supported by monthly personalised coaching sessions delivered by specifically trained tele-coaches. Patients will be provided with a pedometer to allow them to record their daily step count. |
| Intervention type | Behavioural |
| Primary outcome measure | Criteria used to judge the feasibility of progressing to a larger scale evaluation: 1. Total number of patients recruited per month measured using data from a screening log over 6 months 2. Percentage of recruited patients who log in measured using data from the VITALISE digital platform during their 6-month intervention 3. Percentage of patients who logged in to VITALISE and provide follow-up data logged during the follow-up visit at 6 months These criteria aim to retain a sufficient sample size to determine acceptability and feasibility. |
| Secondary outcome measures | To determine whether acceptability and feasibility lead to changes in clinical outcomes, including: 1. Body weight 2. HbA1C 3. Liver enzymes 4. Liver stiffness 5. Blood pressure 6. Lipid profile All measured as part of standard care using standard methods at baseline and 6 months |
| Overall study start date | 11/01/2022 |
| Completion date | 31/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 35 |
| Total final enrolment | 35 |
| Key inclusion criteria | 1. Aged 18 years and over 2. Clinical diagnosis of NAFLD following review by a hepatologist within the last 6 months 3. Willing and able to give written informed consent |
| Key exclusion criteria | 1. Decompensated NASH cirrhosis (Child Pugh score ≥ 7) 2. Diagnosed/previous eating disorder or purging 3. Excessive alcohol consumption (>14 units/week for females; >21 units/week for males) 4. Known cancer (except skin cancer) 5. Myocardial infarction within 6 months or uncontrolled cardiovascular disease 6. Pregnant/considering pregnancy 7. Inability to understand written and verbal English |
| Date of first enrolment | 01/11/2022 |
| Date of final enrolment | 31/05/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor information
Hospital/treatment centre
Level 1 Regent Point
Regent Farm Road
Gosforth
Newcastle upon Tyne
NE3 3HD
England
United Kingdom
| Phone | +44 (0)191 2825789 |
|---|---|
| nuth.nuthsponsorship@nhs.net | |
| Website | http://www.newcastle-hospitals.org.uk/ |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | 1. Planned publication in high-impact peer-reviewed journals 2. Presented at local, national and international meetings and conferences 3. Results of the study will also be made available via the LiverNorth patient support group and the Newcastle upon Tyne Hospitals NHS Charity through both oral presentations and in their newsletters |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 4.0 | 08/06/2022 | 08/08/2022 | No | Yes |
| Protocol article | 19/04/2023 | 20/04/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 30/06/2025 | 02/07/2025 | Yes | No |
Additional files
Editorial Notes
02/07/2025: Publication reference added.
08/05/2025: The individual participant data (IPD) sharing plan and summary were updated.
15/03/2024: Total final enrolment added.
20/04/2023: Publication reference added.
The following changes were made to the trial record:
1. The recruitment end date was changed from 28/02/2023 to 31/05/2023.
2. The overall end date was changed from 31/12/2023 to 31/03/2024.
3. The intention to publish date was changed from 01/03/2024 to 30/06/2024.
4. The plain English summary was updated to reflect these changes.
03/10/2022: The recruitment start date was changed from 01/09/2022 to 01/11/2022.
05/09/2022: Internal review.
31/08/2022: Internal review.
08/08/2022: Trial's existence confirmed by NHS HRA.
