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Lifestyle Guidance Methods in NAFLD (INDIANA)

E

East Limburg Hospital

Status

Completed

Conditions

Non-Alcoholic Fatty Liver Disease

Treatments

Behavioral: Coach
Behavioral: App
Other: Standard of care

Study type

Interventional

Funder types

Other

Identifiers

NCT05792488
Z-2022064

Details and patient eligibility

About

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

Enrollment

300 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • NAFLD based in FibroScan measurements

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 3 patient groups

Standard of care
Other group
Treatment:
Other: Standard of care
Lifestyle coach
Experimental group
Treatment:
Behavioral: Coach
App
Experimental group
Treatment:
Behavioral: App

Trial contacts and locations

1

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Central trial contact

Geert Robaeys, MD. PhD

Data sourced from clinicaltrials.gov

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