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Virtual Reality as a Dietary Education Adjunct for Pediatric Patients With Obesity

Primary Purpose

Diabetes

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Application
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes focused on measuring Virtual Reality

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Ages 6-18 years of age
  • Able to consent or have parental consent
  • Diagnosis of Obesity Grade 1, 2 and 3 at LPCH/SHC facilities

Exclusion Criteria:

  • People who do not consent
  • Significant Cognitive Impairment
  • History of Severe Motion Sickness
  • Visual Problems

Sites / Locations

  • Lucile Packard Children's Hospital Stanford

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Dietary Consult with Virtual Reality (intervention)

Dietary Consult without Virtual Reality (SOC)

Arm Description

Those in the VR group will receive the same educational dietary review by the registered dietician, and additionally participate in a VR experience through an application called Chaos Café. In Chaos Café, patients are immersed into a computer-generated kitchen environment. A humorous robotic chef serves children different food groups. Gameplay is advanced by choosing healthy foods, while eating unhealthy foods does not advance the application.

Those in the SOC group will have the typical appointment, which includes a review of healthy diet choices with a registered dietitian and follow up according to clinic's SOC.

Outcomes

Primary Outcome Measures

Short-term behavior modification
Short-term behavior modification will be assessed by comparing the selection of an appointment exit reward the end of the study visit. Participants will be presented with two options, a sticker and a piece of candy. Selection of reward will be recorded.

Secondary Outcome Measures

Recall
After their appointment, participants will be asked to complete a 10-item questionnaire that reviews the key learning objectives from their appointment. At their followup visit, they will be re-examined at the start of their appointment.
Satisfaction Survey
Participants will be asked to complete a 5-item satisfaction survey related to their educational experience. Each item will have a scale of 1-5 with anchors, probing participants' engagement with the learning material.

Full Information

First Posted
November 21, 2021
Last Updated
August 8, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05141214
Brief Title
Virtual Reality as a Dietary Education Adjunct for Pediatric Patients With Obesity
Official Title
Virtual Reality as a Dietary Education Adjunct for Pediatric Patients With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 24, 2023 (Actual)
Primary Completion Date
January 6, 2024 (Anticipated)
Study Completion Date
January 6, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Childhood obesity is a national crisis, effecting up to 1 in 5 of children in the US. In the Lucile Packard Children's Hospital Pediatric Weight Management Clinic, the investigators educate parents and caregivers about the importance of dietary modification. In addition to physician guidance, the investigators partner with registered dieticians to counsel families during an hour-long interview. However, traditional methods of education are limited by long-term recall. A typical person only recalls 2- 3% of didactic content after a period of 30 days.In order to improve recall and increase involvement of our pediatric patients in their own dietary modifications, the investigators propose a feasibility study investigating the effectiveness of Virtual Reality (VR) in changing dietary choices and improving recall.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
Virtual Reality

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dietary Consult with Virtual Reality (intervention)
Arm Type
Active Comparator
Arm Description
Those in the VR group will receive the same educational dietary review by the registered dietician, and additionally participate in a VR experience through an application called Chaos Café. In Chaos Café, patients are immersed into a computer-generated kitchen environment. A humorous robotic chef serves children different food groups. Gameplay is advanced by choosing healthy foods, while eating unhealthy foods does not advance the application.
Arm Title
Dietary Consult without Virtual Reality (SOC)
Arm Type
No Intervention
Arm Description
Those in the SOC group will have the typical appointment, which includes a review of healthy diet choices with a registered dietitian and follow up according to clinic's SOC.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Application
Intervention Description
In VR application, Chaos Café, patients are immersed into a computer-generated kitchen environment. A humorous robotic chef serves children different food groups. Gameplay is advanced by choosing healthy foods, while eating unhealthy foods does not advance the application.
Primary Outcome Measure Information:
Title
Short-term behavior modification
Description
Short-term behavior modification will be assessed by comparing the selection of an appointment exit reward the end of the study visit. Participants will be presented with two options, a sticker and a piece of candy. Selection of reward will be recorded.
Time Frame
Duration of appointment, typically 2-3 hours
Secondary Outcome Measure Information:
Title
Recall
Description
After their appointment, participants will be asked to complete a 10-item questionnaire that reviews the key learning objectives from their appointment. At their followup visit, they will be re-examined at the start of their appointment.
Time Frame
Duration of appointment, typically 2-3 hours
Title
Satisfaction Survey
Description
Participants will be asked to complete a 5-item satisfaction survey related to their educational experience. Each item will have a scale of 1-5 with anchors, probing participants' engagement with the learning material.
Time Frame
Duration of appointment, typically 2-3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ages 6-18 years of age Able to consent or have parental consent Diagnosis of Obesity Grade 1, 2 and 3 at LPCH/SHC facilities Exclusion Criteria: People who do not consent Significant Cognitive Impairment History of Severe Motion Sickness Visual Problems
Facility Information:
Facility Name
Lucile Packard Children's Hospital Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Virtual Reality as a Dietary Education Adjunct for Pediatric Patients With Obesity

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