NCT04647409

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Oct 2020Dec 2026

Study Start

First participant enrolled

October 26, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

4.5 years

First QC Date

November 26, 2020

Last Update Submit

November 24, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • CLDQ-NAFLD

    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)

    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

Study Arms (1)

participants

OTHER
Other: screening

Interventions

The determination of the prevalence of NAFLD in a general population in Flanders, Belgium

participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older,
  • able to understand Dutch,
  • able to understand the informed consent

You may not qualify if:

  • secondary causes of steatosis
  • excessive alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Geert Robaeys, prof. dr.

    Hasselt University

    PRINCIPAL INVESTIGATOR
  • Leen Heyens, drs.

    Hasselt University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 26, 2020

First Posted

November 30, 2020

Study Start

October 26, 2020

Primary Completion

April 30, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

December 1, 2025

Record last verified: 2025-11

Locations