Virtual Reality Dietary Counseling for Fatty Liver Disease

Overseen By Justin Tondt

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Pregnant, Institutionalized, Other liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help individuals with fatty liver disease improve their diet and lose weight using virtual reality (VR) technology. It compares traditional in-person dietary counseling with a virtual reality program called Immersive Virtual Alimentation and Nutrition (IVAN), which teaches nutrition and portion control. Participants will use the immersive virtual reality program alongside video calls with a dietician. Those diagnosed with fatty liver disease who own a smartphone might be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative technology in dietary management.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Immersive Virtual Alimentation and Nutrition (IVAN) program is safe for dietary counseling?

Research shows that virtual reality (VR) technology, such as the Immersive Virtual Alimentation and Nutrition (IVAN) program, has been safely used in many studies. Participants in these studies have generally handled VR well, with no major safety issues reported. This technology has been used to assist with weight management and promote healthy habits.

The IVAN program uses VR to simplify dietary counseling, helping participants learn about food portions and energy levels. Although this trial does not primarily focus on safety, the strong safety record of VR in similar contexts suggests that most people are likely to tolerate it well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial using Immersive Virtual Alimentation and Nutrition (IVAN) for fatty liver disease because it introduces a novel way to deliver dietary counseling through virtual reality. Unlike the traditional in-person sessions, this virtual reality approach allows participants to engage in an interactive, immersive educational experience on energy density and portion sizes, all while being remotely monitored by a registered dietitian nutritionist (RDN). This method not only makes counseling more accessible and potentially more engaging for patients but also leverages technology to tailor the experience to individual needs, which could lead to better adherence and outcomes.

What evidence suggests that the IVAN program is effective for fatty liver disease?

Research has shown that virtual reality (VR) can enhance healthy eating and exercise, crucial for managing fatty liver disease. In this trial, participants will receive either in-person dietary weight loss counseling or the Immersive Virtual Alimentation and Nutrition (IVAN) program, which uses VR to create an engaging and interactive learning experience. Early results suggest that VR methods like IVAN can address challenges such as cost and travel, improving accessibility. Additionally, the program's interactive approach may make learning about nutrition more engaging and effective. Overall, evidence supports VR-based dietary counseling like IVAN as a promising tool for treating fatty liver disease. ^{1 3 5 6 7}

Who Is on the Research Team?

Justin Tondt, MD

Principal Investigator

Penn State

Are You a Good Fit for This Trial?

This trial is for adults over 18 with metabolic-dysfunction associated steatotic liver disease (fatty liver) confirmed by a Fibroscan. Participants must own a smartphone to access the virtual reality program.

Inclusion Criteria

You have a smartphone.

I am older than 18 years.

You have liver scarring identified through Fibroscan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either in-person or virtual reality dietary weight loss counseling for 12 weeks

12 weeks

Weekly visits (virtual or in-person)

Crossover

Participants crossover to assess the alternative intervention (IVAN program or in-person counseling)

4 weeks

Follow-up

Participants are monitored for changes in dietary intake and body weight after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Immersive Virtual Alimentation and Nutrition (IVAN)

Trial Overview The study compares traditional in-person dietary counseling to an immersive virtual reality dietitian program, assessing their impact on self-reported diet and weight loss in fatty liver disease patients.

How Is the Trial Designed?

Group I: Virtual reality dietary weight loss counseling Experimental Treatment 1 Intervention

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.

Group II: In-person dietary weight loss counseling Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Published Research Related to This Trial

Virtual reality (VR) interventions have shown effectiveness in smoking cessation and reduction, with three studies reporting successful cessation and four showing reduced smoking rates among participants.

VR also demonstrated potential benefits in increasing physical activity and reducing body mass index (BMI) or weight in some studies, although results were mixed and further randomized trials are necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Virtual Reality Interventions on Smoking, Nutrition, Alcohol, Physical Activity and/or Obesity Risk Factors: A Systematic Review. Tatnell, P., Atorkey, P., Tzelepis, F.[2023]

In a study involving 20 overweight and obese individuals, face-to-face (FTF) weight management resulted in a greater initial weight loss of 10.8% compared to 7.6% with virtual reality (VR) after 3 months.

However, during the 6-month maintenance phase, participants using VR maintained a significantly greater weight loss of 14.0% compared to 9.5% for those in the FTF group, suggesting that VR may be more effective for long-term weight maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving weight maintenance using virtual reality (Second Life). Sullivan, DK., Goetz, JR., Gibson, CA., et al.[2013]

The Experience Success (ES) project utilized virtual reality (VR) technology to create a safe and interactive environment for training weight management skills, specifically targeting social eating situations.

Feedback from 37 overweight/obese women indicated that the VR scenario significantly improved their skills, confidence, and commitment to managing their eating behaviors in social contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of and feedback on a fully automated virtual reality system for online training in weight management skills. Thomas, JG., Spitalnick, JS., Hadley, W., et al.[2021]

The ConVRSelf virtual reality platform was well-accepted by participants, particularly among those living with obesity, indicating its potential as a supportive tool for lifestyle changes.

Both normal weight and obese participants showed high readiness to change their habits before and after using the VR system, suggesting that the platform effectively engages users in their journey towards healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual self-conversation using motivational interviewing techniques to promote healthy eating and physical activity: A usability study. Anastasiadou, D., Herrero, P., Vázquez-De Sebastián, J., et al.[2023]

Virtual reality (VR) technologies offer a promising new approach to engage patients in healthier eating and physical activity patterns, which is crucial for managing obesity and diabetes.

The workshop highlighted VR's potential as a research tool to measure and motivate health-related behaviors, suggesting that multidisciplinary collaborations could enhance its application in behavioral science and healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality technologies for research and education in obesity and diabetes: research needs and opportunities. Ershow, AG., Peterson, CM., Riley, WT., et al.[2021]

Virtual reality (VR) technology shows promise in enhancing treatments for eating and weight disorders (EWDs) by integrating with existing evidence-based interventions.

Future applications of VR could include real-time body experience alterations and cue exposure techniques to help reduce food cravings, potentially improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Future Directions: How Virtual Reality Can Further Improve the Assessment and Treatment of Eating Disorders and Obesity. Gutiérrez-Maldonado, J., Wiederhold, BK., Riva, G.[2018]

The Nutri-Expert nutritional education software significantly improved dietetic knowledge among obese patients compared to traditional management, as shown in a study with 557 participants over one year.

Both the Nutri-Expert group and the traditional management group experienced significant improvements in BMI and dietary habits, indicating that while Nutri-Expert enhances knowledge, it does not lead to greater weight loss compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter randomized evaluation of a nutritional education software in obese patients. Turnin, MC., Bourgeois, O., Cathelineau, G., et al.[2016]

The study involving 35 ethnically diverse emerging adults found that food selections made in a virtual reality (VR) buffet were significantly correlated with those made in a real-world buffet, indicating that VR can effectively simulate real-life eating behaviors.

Participants rated their VR buffet experience positively, perceiving it as natural and reflective of their typical food choices, which supports the use of VR as a valid tool for researching food-related behaviors and interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a Virtual Reality Buffet environment to assess food selection processes among emerging adults. Cheah, CSL., Barman, S., Vu, KTT., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-implementation-science-6-2024-cde24

Virtual Reality Dietary Counseling for Fatty Liver Disease Research shows that virtual reality (VR) technologies can help improve healthy eating and physical activity, which are important for managing conditions like ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35534104/

The Immersive Virtual Alimentation and Nutrition Application The Immersive Virtual Alimentation and Nutrition Application: An Interactive Digital Dietitian.

3. trialstoday.org trialstoday.org/search/results?age=51&condition=non-alcoholic%20fatty%20liver&gender=Female&interventionalpurpose=Treatment&q1=B1&q2=P1&radius=any&status=recruiting&type=Interventional&zip=59044/1000&page=eJyLVspLrShR0lHycw4xMDE1MDUxNlPS0bWEARxMI0M9C3NLAxMdQ3NjC2MzCwMw0FHKSy4xMDEztzQ2N1OKBQDW1BSi

23 Feasibility of Immersive Virtual Reality ... Dietary weight loss is a cornerstone of treating fatty liver disease ... outcomes. Type: Interventional. Start ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12337362/

Preliminary effectiveness of VR-enhanced nutrition ... Virtual reality (VR) offers immersive and interactive learning environments that address some of the limitations of traditional nutrition ...

5. hhd.psu.edu hhd.psu.edu/nutr/research/lab/hit-lab/current-studies

Current Studies Feasibility of immersive virtual reality (iVR) dietician program in patients with metabolic-dysfunction associated steatotic liver disease (MASLD). A man stands ...

6. ssri.psu.edu ssri.psu.edu/news/clinical-and-translational-science-institute-awards-six-pilot-grants

Clinical and Translational Science Institute awards six pilot ... Project description: Fatty liver disease is a leading cause of liver failure. Dietary weight loss is a cornerstone of treating fatty liver ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40019425/

Immersive Virtual Reality Dietitian Improves Portion Control ... Analysis: Linear mixed-effects models and t tests. Results: In experiment 1, the portion size self-efficacy improved for both conditions (B = 2.40; SE = 0.61; P ...