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Behavioral Intervention
Virtual Reality Dietary Counseling for Fatty Liver Disease
N/A
Recruiting
Led By Justin Tondt, MD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study the effectiveness of using virtual reality technology, specifically an iVR dietician program called IVAN, to help people with fatty liver disease improve their diet and lose weight. The
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves dietary counseling rather than medication, side effects are minimal but may include discomfort from wearing VR equipment or potential motion sickness from the virtual experience.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Body weight
Change in percent body weight
Secondary study objectives
Change in energy intake
Change in hepatic steatosis
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual reality dietary weight loss counselingExperimental Treatment1 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 counselingActive Control1 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.
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Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
511 Previous Clinical Trials
2,870,866 Total Patients Enrolled
12 Trials studying Obesity
2,627,274 Patients Enrolled for Obesity
Justin Tondt, MDPrincipal InvestigatorPenn State