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临床试验/NCT06215131
NCT06215131已完成不适用

Feasibility of Immersive Virtual Reality Dietician Program in Patients With Metabolic-dysfunction Associated Steatotic Liver Disease

Milton S. Hershey Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Body weight

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults age >18 years
  • MASLD identified on imaging
  • Possession of a smartphone

排除标准

  • Inability to provide informed consent
  • Institutionalized/prisoner
  • Other causes of hepatic steatosis or chronic liver disease
  • Severe medical/psychiatric comorbidities at the study PI's discretion

结局指标

主要结局

Body weight

时间窗: 12 weeks

Kg

Change in percent body weight

时间窗: 12 weeks

Percent change

次要结局

  • Change in hepatic steatosis(12 weeks)
  • Change in energy intake(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Justin Tondt

Assistant Professor of Family and Community Medicine

Milton S. Hershey Medical Center

研究点 (2)

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