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

NCT06215131 | Completed

• 1 other identifier: STUDY00024998
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatty Liver, Nonalcoholic; Weight Loss; Virtual Reality; Implementation Science

Outcome Measures

Primary Outcomes (2)

• Body weight

  Kg

  12 weeks

• Change in percent body weight

  Percent change

  12 weeks

Secondary Outcomes (2)

• Change in energy intake

  12 weeks

• Change in hepatic steatosis

  12 weeks

Study Arms (2)

In-person dietary weight loss counseling

ACTIVE COMPARATOR

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.

Behavioral: In-person dietary weight loss counseling

Virtual reality dietary weight loss counseling

EXPERIMENTAL

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.

Behavioral: Virtual reality dietary weight loss counseling

Interventions

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.

In-person dietary weight loss counseling

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.

Virtual reality dietary weight loss counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Weight Loss

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Justin Tondt, MD

  Penn State

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Family and Community Medicine

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: July 1, 2024
• Primary Completion: September 23, 2025
• Study Completion: September 23, 2025
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)