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OpenTrials
Completed

NCT Number: NCT06215131

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In-person dietary weight loss counseling

Behavioral

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.

Virtual reality dietary weight loss counseling

Behavioral

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.

Primary outcomes

  1. Body weight

    Time frame: 12 weeks

    Kg

  2. Change in percent body weight

    Time frame: 12 weeks

    Percent change

Secondary outcomes

  1. Change in energy intake

    Time frame: 12 weeks

    Calories via ASA24

  2. Change in hepatic steatosis

    Time frame: 12 weeks

    Liver fat measured via Fibroscan

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2024
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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