Fatty Liver, NonalcoholicNCT06215131
Feasibility of Immersive Virtual Reality Dietician Program in Metabolic-dysfunction Associated Steatotic Liver Disease
A study testing In-person dietary weight loss counseling and Virtual reality dietary weight loss counseling in people with Fatty Liver, Nonalcoholic and Weight Loss, run by Milton S. Hershey Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatty Liver, Nonalcoholic, Weight Loss, Virtual Reality
- What is being tested?
- In-person dietary weight loss counseling and Virtual reality dietary weight loss counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 23 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age >18 years
- MASLD identified on imaging
- Possession of a smartphone
Who cannot join
- Inability to provide informed consent
- Institutionalized/prisoner
- Pregnant
- Other causes of hepatic steatosis or chronic liver disease
- Severe medical/psychiatric comorbidities at the study PI's discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine
Hershey, Pennsylvania, 17033
About this study
Official title: Feasibility of Immersive Virtual Reality Dietician Program in Patients With Metabolic-dysfunction Associated Steatotic Liver Disease
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.
- Being tested
- In-person dietary weight loss counseling, Virtual reality dietary weight loss counseling
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person dietary weight loss counselingBehavioural
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 counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| In-person dietary weight loss counseling | Active comparator | 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. Receives: Behavioral: In-person dietary weight loss counseling |
| Virtual reality dietary weight loss counseling | Experimental | 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. Receives: Behavioral: Virtual reality dietary weight loss counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Kg
Measured: 12 weeks
Change in percent body weight
Percent change
Measured: 12 weeks
Secondary outcomes (2)
Change in energy intake
Calories via ASA24
Measured: 12 weeks
Change in hepatic steatosis
Liver fat measured via Fibroscan
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Jul 2024
- Primary completion23 Sep 2025
- Study completion23 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Liver, NonalcoholicStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Tondt, Milton S. Hershey Medical Center
- Investigators
- Justin Tondt, MD, Principal investigator, Penn State
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215131
- Sponsor's protocol ID
- STUDY00024998
- Status last verified
- Oct 2025
- First submitted
- 10 Jan 2024
- Last updated
- 31 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Immersive Virtual Reality Dietician Program in Patients With Metabolic-dysfunction Associated Steatotic Liver Disease
- ClinicalTrials.gov ID
- NCT06215131
- Acronym / sponsor ID
- STUDY00024998
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-person dietary weight loss counseling | Active comparator | Behavioral: In-person dietary weight loss counselingThe 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 | Experimental | Behavioral: Virtual reality dietary weight loss counselingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults age >18 years
- MASLD identified on imaging
- Possession of a smartphone
Key exclusion criteria (5 listed)
- Inability to provide informed consent
- Institutionalized/prisoner
- Pregnant
- Other causes of hepatic steatosis or chronic liver disease
- Severe medical/psychiatric comorbidities at the study PI's discretion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-person dietary weight loss counselingThe 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. | Behavioural | In-person dietary weight loss counseling |
| Virtual reality dietary weight loss counselingThe 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. | Behavioural | Virtual reality dietary weight loss counseling |
Primary outcome
Body weight
Time frame: 12 weeks
Kg
Change in percent body weight
Time frame: 12 weeks
Percent change
2 secondary outcomes
Change in energy intake
Time frame: 12 weeks
Change in hepatic steatosis
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Fatty Liver, Nonalcoholic
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients.
NAFLD (Nonalcoholic Fatty Liver Disease)
Recruiting
iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) +Optimized Lifestyle Intervention (OLI) vs Sham + OLI for Weight Loss
Overweight and/or Obesity, Metabolic Syndrome
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Tondt, MD principal investigator
Penn State
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person dietary weight loss counseling and Virtual reality dietary weight loss counseling in people with Fatty Liver, Nonalcoholic and Weight Loss, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025; AzTrials last refreshed its copy on 2 Nov 2026.