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NCT Number: NCT05141214

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Application

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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"

  3. 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"

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Virtual Reality as a Dietary Education Adjunct for Pediatric Patients With Obesity: A Pragmatic, Randomized Pilot Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 2, 2021
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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