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

Not Applicable

Recruiting

• Conditions: Fatty Liver, Nonalcoholic; Weight Loss; Virtual Reality; Implementation Science
• Interventions: Behavioral: Virtual reality dietary weight loss counseling; Behavioral: In-person dietary weight loss counseling

• Registration Number: NCT06215131
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-10
• Study First Posted: 2024-01-22
• Study Start: 2024-07-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-11
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality dietary weight loss counseling	Virtual reality dietary weight loss counseling	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.
In-person dietary weight loss counseling	In-person dietary weight loss counseling	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.

Primary Outcome Measures

Name	Time	Method
Body weight	12 weeks	Kg
Change in percent body weight	12 weeks	Percent change

Secondary Outcome Measures

Name	Time	Method
Change in hepatic steatosis	12 weeks	Liver fat measured via Fibroscan
Change in energy intake	12 weeks	Calories via ASA24

Trial Locations

Locations (1)

Penn State College of Medicine; 🇺🇸 Hershey, Pennsylvania, United States