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Feasibility of Immersive Virtual Reality Dietician Program in Metabolic-dysfunction Associated Steatotic Liver Disease

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Penn State Health

Status

Completed

Conditions

Weight Loss
Implementation Science
Fatty Liver, Nonalcoholic
Virtual Reality

Treatments

Behavioral: Virtual reality dietary weight loss counseling
Behavioral: In-person dietary weight loss counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT06215131
STUDY00024998

Details and patient eligibility

About

Metabolic-dysfunction associated steatotic liver disease, often referred to as "fatty liver disease", is a leading cause of liver failure. Dietary weight loss is a cornerstone of treating fatty liver disease, but access to traditional in-person nutritional education is often limited by cost, availability, and transportation. Immersive virtual reality (iVR) has the potential to not only overcome these barriers, but also provide an interactive learning experience, such as measuring and preparing foods. Therefore, the investigators have created and validated an iVR dietician program known as the Immersive Virtual Alimentation and Nutrition (IVAN) using evidence-informed practices from the Academy of Nutrition and Dietetics.

The goal of this project is to translate the IVAN program from human and patient research to practice and community research. The investigators plan to accomplish this by performing a randomized clinical trial evaluating the effect of the IVAN program in combination with synchronous audio/video dietary counseling on self-reported dietary intake and weight compared to in-person counseling. Concurrently, the investigators will provide a survey assessing implementation outcomes to both groups as well as the dietician at each study visit, and crossover the intervention at study completion so all participants assess the IVAN program. Additionally, the investigators will have clinic health care providers experience the IVAN program and assess implementation outcomes.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adults age >18 years
  • MASLD identified on imaging
  • Possession of a smartphone

Exclusion criteria

  • Inability to provide informed consent
  • Institutionalized/prisoner
  • Pregnant
  • Other causes of hepatic steatosis or chronic liver disease
  • Severe medical/psychiatric comorbidities at the study PI's discretion

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

In-person dietary weight loss counseling
Active Comparator group
Description:
The counseling content will be 30 minutes of RDN delivered educational session on energy density and portion sizes then the second 30 minutes being the RDN answering participant questions and providing feedback.
Treatment:
Behavioral: In-person dietary weight loss counseling
Virtual reality dietary weight loss counseling
Experimental group
Description:
The counseling content will be 30 minutes of virtual reality delivered educational session on energy density and portion sizes with an RDN remotely monitoring then the second 30 minutes being the RDN answering participant questions and providing feedback through synchronous audio/video.
Treatment:
Behavioral: Virtual reality dietary weight loss counseling

Trial contacts and locations

1

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Central trial contact

Justin Tondt

Data sourced from clinicaltrials.gov

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