NCT05792488

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 24, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

2.4 years

First QC Date

November 7, 2022

Last Update Submit

July 2, 2025

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

  • A change in liver fat

    As measured by the controlled attenuation parameter in the intervention arms as compared to standard of care

    1 year

Study Arms (3)

Standard of care

OTHER
Other: Standard of care

Lifestyle coach

EXPERIMENTAL
Behavioral: Coach

App

EXPERIMENTAL
Behavioral: App

Interventions

CoachBEHAVIORAL

Coaching to a healthy lifestyle

Lifestyle coach
AppBEHAVIORAL

The app will coach people to a healthy lifestyle

App
Standard of careOTHER

Patients will receive standardized lifestyle advice by their specialist

Standard of care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • NAFLD based in FibroScan measurements

You may not qualify if:

  • excessive alcohol use
  • other causes of liver disease
  • secondary causes of liver steatosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

DoulasAmyloidStandard of Care

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and ServicesMultiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and ProteinsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Geert Robaeys, MD. PhD

    Hasselt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 7, 2022

First Posted

March 31, 2023

Study Start

October 24, 2022

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

July 9, 2025

Record last verified: 2025-07

Locations

BE(1)