Lifestyle Guidance Methods in NAFLD | NCT05792488

Studies
Lifestyle Guidance Methods in NAFLD

NCT05792488

Sponsor

Ziekenhuis Oost-Limburg

Status

Completed

Last Update Posted

Jul 9, 2025Actual

Enrollment

300Actual

Phase

Not Applicable

Conditions

Non-Alcoholic Fatty Liver Disease

Interventions

Coach
App
Standard of care

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 24, 2022Actual

Primary Completion Date

Mar 31, 2025Actual

Completion Date

Mar 31, 2025Actual

First Submitted Date

Nov 7, 2022

First Submission Date that Met QC Criteria

Mar 28, 2023

First Posted Date

Mar 31, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2025

Last Update Posted Date

Jul 9, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Standard of care	Other	Other: Standard of care
Lifestyle coach	Experimental	Behavioral: Coach
App	Experimental	Behavioral: App

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coach	Behavioral	Coaching to a healthy lifestyle	Lifestyle coach

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
A change in liver fat	As measured by the controlled attenuation parameter in the intervention arms as compared to standard of care	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

NAFLD based in FibroScan measurements

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Geert Robaeys, MD. PhD	Hasselt University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ziekenhuis Oost-Limburg		Genk	Limburg	3600	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059037	Doulas
D000682	Amyloid
D059039	Standard of Care

Ancestor Terms

ID	Term
D006282	Health Personnel
D005159	Health Care Facilities Workforce and Services
D046912	Multiprotein Complexes
D046911	Macromolecular Substances

Browse Leaves

Not provided

Browse Branches

Not provided