- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05141214
Virtual Reality as a Dietary Education Adjunct for Pediatric Patients With Obesity
June 10, 2024 updated by: Thomas Caruso, Stanford University
Virtual Reality as a Dietary Education Adjunct for Pediatric Patients With Obesity: A Pragmatic, Randomized Pilot Study
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 pragmatic, randomized pilot study investigating the effectiveness of Virtual Reality (VR) in changing dietary choices and improving recall.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Lucile Packard Children's Hospital Stanford
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Dietary Consult with Virtual Reality (intervention)
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.
|
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.
|
|
No Intervention: Dietary Consult without Virtual Reality (SOC)
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Immediate behavior modification
Time Frame: Duration of appointment, typically 2-3 hours
|
Immediate 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, either a bag of chips or a healthier alternative.
Selection of reward will be recorded.
|
Duration of appointment, typically 2-3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric Adapted Liking Survey
Time Frame: Duration of appointment, typically 2-3 hours
|
The survey uses a continuous scale from -100 to 100 to indicate patients' like or dislike of certain foods.
The survey was completed by participants after their dietary counseling.
The responses were categorized into seven groups, 3 negative, 1 neutral, and 3 positive.
-3=[-100,-67], -2=[-66,-34], -1=[-33,-1], 0=0, 1=[1,33], 2=[34,66], 3=[67,100].
Likability of foods were also categorized into fruits, fatty/salty/sugary (FSS), proteins and vegetables.
|
Duration of appointment, typically 2-3 hours
|
|
Nutritional knowledge survey
Time Frame: Duration of appointment, typically 2-3 hours
|
15-item survey based on the counseling sessions with questions such as "If I have vegetables at home, a healthy way to eat them would be: a) fresh, b) fried, c)with cheese dip, d)in a smoothie"
|
Duration of appointment, typically 2-3 hours
|
|
Satisfaction Survey
Time Frame: Duration of appointment, typically 2-3 hours
|
5-point satisfaction survey for participants who completed VR experience with questions such as "The technology helps me remember what good food choices are (select one option): (1) Not at all, (2), (3) A little bit, (4), (5) A lot"
|
Duration of appointment, typically 2-3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 24, 2023
Primary Completion (Actual)
August 15, 2023
Study Completion (Actual)
August 15, 2023
Study Registration Dates
First Submitted
November 21, 2021
First Submitted That Met QC Criteria
November 21, 2021
First Posted (Actual)
December 2, 2021
Study Record Updates
Last Update Posted (Actual)
June 12, 2024
Last Update Submitted That Met QC Criteria
June 10, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 63298
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.