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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06215131
• Other study ID #: Tondt-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: May 30, 2025

Study information

• Verified date: March 2024
• Source: Milton S. Hershey Medical Center
• Contact: Justin Tondt
• Phone: 717-531-0003
• Email: StineLaboratory[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults age >18 years

• MASLD identified on Fibroscan

• Possession of a smartphone

Exclusion Criteria:

• Inability to provide informed consent

• Institutionalized/prisoner

• Pregnant

• Active weight-loss medication use

• Other causes of hepatic steatosis or chronic liver disease

• Severe medical/psychiatric comorbidities at the study PI's discretion

Related Conditions & MeSH terms

• Fatty Liver
• Fatty Liver, Nonalcoholic
• Implementation Science
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Virtual Reality
• Weight Loss

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Kg	12 weeks
Primary	Change in percent body weight	Percent change	12 weeks
Secondary	Change in energy intake	Calories via ASA24	12 weeks
Secondary	Change in hepatic steatosis	Liver fat measured via Fibroscan	12 weeks