NCT07192874

Dietary Intervention Using a Gluten-free App to Improve Tracking, Adherence, and Learning(DIGITAL) Study

DIGITAL Study: Evaluating "MyMedDiary" as a Tool for Improving Gluten-Free Diet Adherence and Knowledge in Children With Newly Diagnosed Celiac Disease

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Celiac Disease in Children

Interventions

Type	Name	Description
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, including recipe-level data. The backend system stores encrypted data securely in Microsoft Azure, and dietary entries are automatically converted to nutrient data using a standardized reference system. Researchers access de-identified participant data and analytics through a secure online dashboard. The system supports multicenter trials.
OTHER	Feedback on Gluten Exposure	The MyMedDiary Application will provide feedback on potential gluten exposure when participants input dietary record information into the application.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-01-01
• Completion: 2027-09-01
• First posted: 2025-09-25
• Last updated: 2025-09-29