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CompletedNCT05141214Updated Jun 12, 2024

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

An interventional study of Virtual Reality Application in Diabetes, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-12.

Sponsored by Stanford University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study 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 pragmatic, randomized pilot study investigating the effectiveness of Virtual Reality (VR) in changing dietary choices and improving recall.

02

Conditions studied

  • Diabetes

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Keywords

  • Virtual Reality
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 48 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • People who do not consent
  • Significant Cognitive Impairment
  • History of Severe Motion Sickness
  • Visual Problems
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • 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.

    Behavioral: Virtual Reality 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.

Interventions

  • BehavioralVirtual Reality 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.

06

What researchers measure

Primary outcomes

  1. Immediate behavior modification

    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.

    Time frame: Duration of appointment, typically 2-3 hours

Secondary outcomes

  1. Pediatric Adapted Liking Survey

    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.

    Time frame: Duration of appointment, typically 2-3 hours

  2. Nutritional knowledge survey

    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"

    Time frame: Duration of appointment, typically 2-3 hours

  3. Satisfaction Survey

    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"

    Time frame: Duration of appointment, typically 2-3 hours

07

Study locations

1 site
  • Lucile Packard Children's Hospital Stanford
    Palo Alto, California 94304, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05141214
Lead sponsor
Stanford University
Responsible party
Thomas Caruso (Clinical Professor, Stanford University) — Principal investigator
First posted
Dec 2, 2021
Start date
Feb 24, 2023
Primary completion
Aug 15, 2023
Completion
Aug 15, 2023
Last update
Jun 12, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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