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NCT05792488 Clinical Trial

Lifestyle Guidance Methods in NAFLD

Non-Alcoholic Fatty Liver Disease Clinical Trial

— INDIANA  

Official title:
The Investigation of Different Guidance Methods to Facilitate Lifestyle Changes in Patients With NAFLD

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05792488
Other study ID # Z-2022064
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 24, 2022
Est. completion date November 1, 2025

Study information
Verified date February 2024
Source Ziekenhuis Oost-Limburg
Contact Geert Robaeys, MD. PhD
Phone +32 89 21 20 55
Email nafldstudie@zol.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the efficiency of lifestyle modification (due to a dietitian or digital application) compared to standard of care.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date November 1, 2025
Est. primary completion date November 1, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - NAFLD based in FibroScan measurements Exclusion Criteria: - excessive alcohol use - other causes of liver disease - secondary causes of liver steatosis

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Coach
Coaching to a healthy lifestyle
• App
The app will coach people to a healthy lifestyle
Other:
• Standard of care
Patients will receive standardized lifestyle advice by their specialist

Locations
Country Name City State
Belgium Ziekenhuis Oost-Limburg Genk Limburg

Sponsors (1)
Lead Sponsor Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary A change in liver fat As measured by the controlled attenuation parameter in the intervention arms as compared to standard of care 1 year
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