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Clinical Trials/ISRCTN12893503
ISRCTN12893503
Active, Not Recruiting
N/A

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)

ewcastle upon Tyne Hospitals NHS Foundation Trust0 sites35 target enrollmentAugust 30, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
ewcastle upon Tyne Hospitals NHS Foundation Trust
Enrollment
35
Status
Active, Not Recruiting
Last Updated
2 years ago

Overview

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37076916/ (added 20/04/2023)

Registry
who.int
Start Date
August 30, 2022
End Date
March 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
ewcastle upon Tyne Hospitals NHS Foundation Trust

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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