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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Immersive Virtual Alimentation and Nutrition (IVAN) 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 obesity and diabetes. These findings suggest that VR could also be effective in promoting lifestyle changes needed for managing fatty liver disease. ^{1 2 3 4 5}

Is virtual reality dietary counseling safe for humans?

Virtual reality (VR) technology has been used safely in various studies for weight management and promoting healthy behaviors, with participants generally finding it helpful and safe. However, more research is needed to confirm its safety across different conditions. ^{1 3 5 6 7}

How is the treatment IVAN unique for managing fatty liver disease?

IVAN uses virtual reality (VR) technology to provide an immersive and interactive environment for dietary counseling, which is different from traditional treatments that may not engage patients as effectively. This approach can help patients adopt healthier eating habits by simulating real-life food choices and providing personalized feedback, making it a novel way to manage dietary aspects of fatty liver disease. ^{2 3 4 6 8}

Research Team

Justin Tondt, MD

Principal Investigator

Penn State

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual self-conversation using motivational interviewing techniques to promote healthy eating and physical activity: A usability study. [2023]

2. France pubmed.ncbi.nlm.nih.gov

Multicenter randomized evaluation of a nutritional education software in obese patients. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Virtual reality technologies for research and education in obesity and diabetes: research needs and opportunities. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Future Directions: How Virtual Reality Can Further Improve the Assessment and Treatment of Eating Disorders and Obesity. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Improving weight maintenance using virtual reality (Second Life). [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Development of and feedback on a fully automated virtual reality system for online training in weight management skills. [2021]

7. Switzerland 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Validation of a Virtual Reality Buffet environment to assess food selection processes among emerging adults. [2021]