- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04647409
Screening for NAFLD in Flanders
November 24, 2025 updated by: Geert Robaeys, Hasselt University
Screening for Non-Alcoholic Fatty Liver Disease (NAFLD) in a General Practitioner Population, in Flanders, Belgium.
In the Belgian adult population more than half, and numbers are still increasing, of the population is overweight or obese.
These people are at risk to develop NAFLD.
However, we lack epidemiological data in Belgium.
Therefore, it is important to do epidemiological studies to investigate NAFLD prevalence and disease severity based on a non-invasive approach and evaluate how patients are to be referred.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
10000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hasselt, Belgium, 3500
- Hasselt University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18 years or older,
- able to understand Dutch,
- able to understand the informed consent
Exclusion Criteria:
- secondary causes of steatosis
- excessive alcohol abuse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: participants
|
The determination of the prevalence of NAFLD in a general population in Flanders, Belgium
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CLDQ-NAFLD
Time Frame: baseline
|
The determination of the prevalence of NAFLD in a general population in Flanders, Belgium by using A disease-specific quality of life instrument for non-alcoholic fatty liver disease and non-alcoholic steatohepatitis
|
baseline
|
|
36-Item Short Form Survey (SF-36)
Time Frame: baseline
|
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.
These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients.
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Leen Heyens, drs., Hasselt University
- Principal Investigator: Geert Robaeys, prof. dr., Hasselt University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 26, 2020
Primary Completion (Actual)
April 30, 2025
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
November 26, 2020
First Submitted That Met QC Criteria
November 26, 2020
First Posted (Actual)
November 30, 2020
Study Record Updates
Last Update Posted (Actual)
December 1, 2025
Last Update Submitted That Met QC Criteria
November 24, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Liver Diseases
- Fatty Liver
- Non-alcoholic Fatty Liver Disease
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Diagnostic Techniques and Procedures
- Diagnosis
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Health Services
- Health Care Facilities Workforce and Services
- Preventive Health Services
- Diagnostic Services
- Health Surveys
- Surveys and Questionnaires
- Public Health Practice
- Mass Screening
Other Study ID Numbers
- SCREEFLAN-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.