Dietary Intervention Using a Gluten-free App to Improve Tracking, Adherence, and Learning(DIGITAL) Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MyMedDiary, Feedback on Gluten Exposure.
- Who it may be relevant to
- Registry conditions: Celiac Disease in Children. Basic parameters: 2 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
DIGITAL Study: Evaluating "MyMedDiary" as a Tool for Improving Gluten-Free Diet Adherence and Knowledge in Children With Newly Diagnosed Celiac Disease
Overview
With rising incidence of celiac disease(CeD) (3% of population), there is an urgent need for practical, efficient and usable application that can feedback to families and providers about their ultra-processed gluten-free food (UPGFF) consumption as well as to help families identify where they may be having unintentional gluten exposure. The investigators propose to use MyMedDiary, a researcher driven platform dedicated to streamline and enhance dietary data collection, to first validate that it can accurately and efficiently identify gluten-free foods which are ultra-processed. The investigators aim to provide feedback to families on potential sources of gluten exposure as they transition to a gluten-free diet(GFD).
Interventions
- Other MyMedDiary
myMedDiary is a HIPAA-compliant, researcher-configurable mobile and web-based application designed for real-time dietary, symptom and lifestyle data collection. It was utilized to collect dietary data in an IRB-approved study at Seattle Children's Hospital evaluating the dietary cost burden of gluten-free foods in pediatric patients with celiac disease (submitted for publication). The application enables participants to log meals using barcode scanning, keyword search, and manual entry, includin - Other Feedback on Gluten Exposure
The MyMedDiary Application will provide feedback on potential gluten exposure when participants input dietary record information into the application.
Primary outcome measures
- Differences in mean percentage estimates of ultra-processed foods within the overall diet(via the NOVA classification of ultraprocessed foods) [Time frame: 6 MONTHS on a GFD]
Secondary outcome measures (3)
- Differences in mean percentage estimates of ultra-processed foods within the overall diet at diagnostic endoscopy, 2 months and 4 months between MyMedDiary and Paper Dietary Recall [Time frame: Diagnostic endoscopy/initial entry, 2 months on a GFD, and 4 months on a GFD]
- Differences in GFD adherence scores via Celiac Dietary Adherence Test (CDAT) [Time frame: 6 months]
- Differences in GFD Knowledge scores via GFD Knowledge Scale [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Children (2-18 years of age) with a new diagnosis of celiac disease
Exclusion criteria
- Children allergic to more than 2 of the top 8 food allergens and/or with co-morbid conditions treated with dietary modifications will be excluded
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07192874 · IRB-P00051858