NCT05141214

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 24, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

November 21, 2021

Last Update Submit

June 10, 2024

Conditions

Keywords

Virtual Reality

Outcome Measures

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.

    Duration of appointment, typically 2-3 hours

Secondary Outcomes (3)

  • Pediatric Adapted Liking Survey

    Duration of appointment, typically 2-3 hours

  • Nutritional knowledge survey

    Duration of appointment, typically 2-3 hours

  • Satisfaction Survey

    Duration of appointment, typically 2-3 hours

Study Arms (2)

Dietary Consult with Virtual Reality (intervention)

ACTIVE COMPARATOR

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

Dietary Consult without Virtual Reality (SOC)

NO INTERVENTION

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

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.

Dietary Consult with Virtual Reality (intervention)

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 21, 2021

First Posted

December 2, 2021

Study Start

February 24, 2023

Primary Completion

August 15, 2023

Study Completion

August 15, 2023

Last Updated

June 12, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations