Back to resultsLifestyle Guidance Methods in NAFLD (INDIANA)
Primary Purpose
Non-Alcoholic Fatty Liver Disease
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Coach
App
Standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease
Eligibility Criteria
Inclusion Criteria: NAFLD based in FibroScan measurements Exclusion Criteria: excessive alcohol use other causes of liver disease secondary causes of liver steatosis
Sites / Locations
- Ziekenhuis Oost-LimburgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Experimental
Arm Label
Standard of care
Lifestyle coach
App
Arm Description
Outcomes
Primary Outcome Measures
A change in liver fat
As measured by the controlled attenuation parameter in the intervention arms as compared to standard of care
Secondary Outcome Measures
Full Information
NCT ID
NCT05792488
First Posted
November 7, 2022
Last Updated
March 28, 2023
Sponsor
Ziekenhuis Oost-Limburg
1. Study Identification
Unique Protocol Identification Number
NCT05792488
Brief Title
Lifestyle Guidance Methods in NAFLD
Acronym
INDIANA
Official Title
The Investigation of Different Guidance Methods to Facilitate Lifestyle Changes in Patients With NAFLD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2022 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziekenhuis Oost-Limburg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the efficiency of lifestyle modification (due to a dietitian or digital application) compared to standard of care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
Other
Arm Title
Lifestyle coach
Arm Type
Experimental
Arm Title
App
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Coach
Intervention Description
Coaching to a healthy lifestyle
Intervention Type
Behavioral
Intervention Name(s)
App
Intervention Description
The app will coach people to a healthy lifestyle
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Patients will receive standardized lifestyle advice by their specialist
Primary Outcome Measure Information:
Title
A change in liver fat
Description
As measured by the controlled attenuation parameter in the intervention arms as compared to standard of care
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
NAFLD based in FibroScan measurements
Exclusion Criteria:
excessive alcohol use
other causes of liver disease
secondary causes of liver steatosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geert Robaeys, MD. PhD
Phone
+32 89 21 20 55
Email
nafldstudie@zol.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert Robaeys, MD. PhD
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geert Robaeys, MD. PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Lifestyle Guidance Methods in NAFLD
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