Lifestyle Guidance Methods in NAFLD (INDIANA)

February 28, 2024 updated by: Mathieu Struyve, Ziekenhuis Oost-Limburg

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

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 Contact

Study Locations

  • Belgium
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Recruiting
        • Ziekenhuis Oost-Limburg
        • Contact:
          • Geert Robaeys, MD. PhD

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • NAFLD based in FibroScan measurements

Exclusion Criteria:

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard of care
Other: Standard of care
Patients will receive standardized lifestyle advice by their specialist
Experimental: Lifestyle coach
Behavioral: Coach
Coaching to a healthy lifestyle
Experimental: App
Behavioral: App
The app will coach people to a healthy lifestyle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziekenhuis Oost-Limburg

Investigators

  • Principal Investigator: Geert Robaeys, MD. PhD, 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 24, 2022

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z-2022064

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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