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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05141214
Other study ID # 63298
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 24, 2023
Est. completion date August 15, 2023

Study information

Verified date April 2024
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date August 15, 2023
Est. primary completion date August 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Virtual 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.

Locations

Country Name City State
United States Lucile Packard Children's Hospital Stanford Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Duration of appointment, typically 2-3 hours
Secondary 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" Duration of appointment, typically 2-3 hours
Secondary 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" Duration of appointment, typically 2-3 hours
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