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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06215131
Other study ID # Tondt-001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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