Non-Alcoholic Fatty Liver DiseaseINDIANANCT05792488
Lifestyle Guidance Methods in NAFLD
A study testing Coach and App in people with Non-Alcoholic Fatty Liver Disease, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
To determine the efficiency of lifestyle modification (due to a dietitian or digital application) compared to standard of care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Coach and App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Oct 2022to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- NAFLD based in FibroScan measurements
Who cannot join
- excessive alcohol use
- other causes of liver disease
- secondary causes of liver steatosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Investigation of Different Guidance Methods to Facilitate Lifestyle Changes in Patients With NAFLD
To determine the efficiency of lifestyle modification (due to a dietitian or digital application) compared to standard of care.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Coach, App, Standard of care
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoachBehavioural
Coaching to a healthy lifestyle
AppBehavioural
The app will coach people to a healthy lifestyle
Standard of careOther
Patients will receive standardized lifestyle advice by their specialist
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Other | Not described Receives: Other: Standard of care |
| Lifestyle coach | Experimental | Not described Receives: Behavioral: Coach |
| App | Experimental | Not described Receives: Behavioral: App |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change in liver fat
As measured by the controlled attenuation parameter in the intervention arms as compared to standard of care
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start24 Oct 2022
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathieu Struyve, Ziekenhuis Oost-Limburg
- Investigators
- Geert Robaeys, MD. PhD, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792488
- Sponsor's protocol ID
- Z-2022064
- Acronym
- INDIANA
- Status last verified
- Jul 2025
- First submitted
- 7 Nov 2022
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Robaeys W, Heyens LJ, Bruckers L, Penders J, Struyve M, Koek GH, Francque SM, Robaeys GK. Randomised trial of lifestyle interventions for improving metabolic dysfunction-associated steatotic liver disease. Hepatol Int. 2026 Oct 5. doi: 10.1007/s12072-026-11153-w. Online ahead of print.
PubMed 42834257
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of Different Guidance Methods to Facilitate Lifestyle Changes in Patients With NAFLD
- ClinicalTrials.gov ID
- NCT05792488
- Acronym / sponsor ID
- INDIANA / Z-2022064
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the efficiency of lifestyle modification (due to a dietitian or digital application) compared to standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Other | Other: Standard of care |
| Lifestyle coach | Experimental | Behavioral: Coach |
| App | Experimental | Behavioral: App |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- NAFLD based in FibroScan measurements
Key exclusion criteria (3 listed)
- excessive alcohol use
- other causes of liver disease
- secondary causes of liver steatosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoachCoaching to a healthy lifestyle | Behavioural | Lifestyle coach |
| AppThe app will coach people to a healthy lifestyle | Behavioural | App |
| Standard of carePatients will receive standardized lifestyle advice by their specialist | Other | Standard of care |
Primary outcome
A change in liver fat
Time frame: 1 year
As measured by the controlled attenuation parameter in the intervention arms as compared to standard of care
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Derived from this study: PubMed 42834257Robaeys W, Heyens LJ, Bruckers L, Penders J, Struyve M, Koek GH, Francque SM, Robaeys GK. Randomised trial of lifestyle interventions for improving metabolic dysfunction-associated steatotic liver disease. Hepatol Int. 2026 Oct 5. doi: 10.1007/s12072-026-11153-w. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geert Robaeys, MD. PhD principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coach and App in people with Non-Alcoholic Fatty Liver Disease, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A change in liver fat (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05792488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.