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Virtual Reality to Teach, Improve Outcomes, and Engage (VIRTUE): Virtual Reality to Improve Gluten-Free Diet Knowledge in Pediatric Celiac Disease

Virtual Reality to Teach, Improve Outcomes, and Engage (VIRTUE): Virtual Reality to Improve Gluten-Free Diet Knowledge in Pediatric Celiac Disease, A Randomized Clinical Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04440501
Acronym
VIRTUE
Enrollment
100
Registered
2020-06-19
Start date
2022-09-28
Completion date
2026-01-28
Last updated
2022-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease in Children

Brief summary

1. Specific Aim (1) is to assess both the immediate and longer term impact of VIRTUE on the patient's GFD knowledge compared to standard of care (SOC) dietary education. 2. Specific Aim (2) is to determine the impact of VIRTUE on patient QoL, symptomatology, and Celiac biomarkers (tissue transglutaminase antibodies, deamidated gliadin peptide IgA, deamidated gliadin peptide IgG, and total serum IgA).

Detailed description

The global burden of Celiac Disease (CD) is estimated to be 1% in Western countries and 0.7-1.4% of the global population.The only treatment for CD is a strict, lifelong Gluten Free Diet (GFD). However, dietary adherence is the main barrier against disease control. Whereas experiential learning, learning through experience, has been associated with greater impact in achieving desired nutritional outcomes in pediatric populations. Replicating the environments in which patients would make food choices in clinic is not feasible. Previous research, in addition to preliminary results indicate that Virtual reality (VR) may act as an effective precursor to the real world by providing a safe and immersive learning environment. As such, the investigators seek to investigate how VR use to Teach, Improve Outcomes, and Engage (VIRTUE) will affect patient GFD knowledge, QoL, symptoms, and CD biomarkers. The central hypothesis will tested through the following specific aims: 1. Specific Aim (1) is to assess the immediate and long-term impact of VIRTUE on children's GFD knowledge compared to SOC education. The investigators hypothesize that VIRTUE with SOC education, will improve children's GFD knowledge by 10-20%, opposed to SOC alone 2. Specific Aim (2) is to determine the impact of VIRTUE on patient QoL. The investigators hypothesize that VIRTUE with SOC education, will improve children's QoL scores, opposed to SOC alone. 3. Specific Aim (3) is to determine the impact of VIRTUE on decline of CD biomarkers (tissue transglutaminase antibodies and deamidated gliadin peptide IgG). The investigators hypothesize that VIRTUE with SOC education, will reduce levels of CD biomarkers faster, compared to SOC alone.

Interventions

DEVICEVirtual Reality Goggles to provide education a regarding the gluten free diet.

To watch and participate in a virtual reality educational experience regarding the gluten free diet.

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with confirmed diagnosis of CD per American or European Guidelines * Ages 8-18 years of all genders

Exclusion criteria

-Significant Developmental Delays

Design outcomes

Primary

MeasureTime frameDescription
Knowledge of the Gluten Free Diet9 monthsGFD-KS at the initial and clinic follow up visit

Secondary

MeasureTime frameDescription
CD Quality of Life9 monthsQoL survey
Biomarkers to asses status of GFD6-9 monthsBiomarkers maximum value (Ttg IgA and Dgp IgA)

Contacts

Primary ContactNasha Khavari, MD,MPH
nkhavari@stanford.edu6504986295
Backup ContactVenus Kalami, MNSP, RD
VKalami@stanfordchildrens.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026