Weight Loss Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 24 |
Est. completion date | May 30, 2025 |
Est. primary completion date | May 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults age >18 years - MASLD identified on Fibroscan - Possession of a smartphone Exclusion Criteria: - Inability to provide informed consent - Institutionalized/prisoner - Pregnant - Active weight-loss medication use - Other causes of hepatic steatosis or chronic liver disease - Severe medical/psychiatric comorbidities at the study PI's discretion |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Milton S. Hershey Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body weight | Kg | 12 weeks | |
Primary | Change in percent body weight | Percent change | 12 weeks | |
Secondary | Change in energy intake | Calories via ASA24 | 12 weeks | |
Secondary | Change in hepatic steatosis | Liver fat measured via Fibroscan | 12 weeks |
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