DiabetesNCT05141214
Virtual Reality as a Dietary Education Adjunct for Pediatric Patients With Obesity
A study testing Virtual Reality Application in people with Diabetes, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Virtual Reality Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2023to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- People who do not consent
- Significant Cognitive Impairment
- History of Severe Motion Sickness
- Visual Problems
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
About this study
Official title: 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.
- Conditions
- Diabetes
- Being tested
- Virtual Reality Application
- Keywords
- Virtual Reality
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality ApplicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of appointment, typically 2-3 hours
Secondary outcomes (3)
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.
Measured: Duration of appointment, typically 2-3 hours
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"
Measured: Duration of appointment, typically 2-3 hours
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"
Measured: Duration of appointment, typically 2-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start24 Feb 2023
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Caruso, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141214
- Sponsor's protocol ID
- 63298
- Status last verified
- Jun 2024
- First submitted
- 21 Nov 2021
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality as a Dietary Education Adjunct for Pediatric Patients With Obesity: A Pragmatic, Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT05141214
- Acronym / sponsor ID
- 63298
- Conditions
- Diabetes
- Keywords
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Consult with Virtual Reality (intervention) | Active comparator | Behavioral: Virtual Reality ApplicationThose 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. |
| 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- People who do not consent
- Significant Cognitive Impairment
- History of Severe Motion Sickness
- Visual Problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality ApplicationIn 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. | Behavioural | Dietary Consult with Virtual Reality (intervention) |
Primary outcome
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.
3 secondary outcomes
Pediatric Adapted Liking Survey
Time frame: Duration of appointment, typically 2-3 hours
Nutritional knowledge survey
Time frame: Duration of appointment, typically 2-3 hours
Satisfaction Survey
Time frame: Duration of appointment, typically 2-3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Application in people with Diabetes, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate behavior modification (time frame: Duration of appointment, typically 2-3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.