RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-01
Study Completion:2025-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06215131

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults age \>18 years
  2. * MASLD identified on imaging
  3. * Possession of a smartphone
  1. * Inability to provide informed consent
  2. * Institutionalized/prisoner
  3. * Pregnant
  4. * Other causes of hepatic steatosis or chronic liver disease
  5. * Severe medical/psychiatric comorbidities at the study PI's discretion

Contacts and Locations

Study Contact

Justin Tondt
CONTACT
717-531-0003
StineLaboratory@pennstatehealth.psu.edu

Principal Investigator

Justin Tondt, MD
PRINCIPAL_INVESTIGATOR
Penn State

Study Locations (Sites)

Penn State College of Medicine
Hershey, Pennsylvania, 17033
United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

  • Justin Tondt, MD, PRINCIPAL_INVESTIGATOR, Penn State

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01
Study Completion Date2025-05-30

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2025-05-30

Terms related to this study

Additional Relevant MeSH Terms

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