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

NCT07192874 | Not Yet Recruiting

• 1 other identifier: IRB-P00051858
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

CELIAC

Outcome Measures

Primary Outcomes (1)

• Differences in mean percentage estimates of ultra-processed foods within the overall diet(via the NOVA classification of ultraprocessed foods)

  Estimates of the dietary relative contributions of each NOVA groups(this is an ultraprocessing food score system from 1-4) will be obtained by MyMedDiary with parallel paper based manual recall and manual dietary classification at 4 different time point (at initial entry, 2-month, 4-month and 6-month). The primary outcome will be differences in calculating mean contributions of ultra-processed foods at 6 month.

  6 MONTHS on a GFD

Secondary Outcomes (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

  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)

  6 months

• Differences in GFD Knowledge scores via GFD Knowledge Scale

  6 months

Study Arms (2)

With Feedback on Gluten-Free Diet

EXPERIMENTAL

Participants will get feedback from the application as to whether they may have had a potential gluten exposure or that their food that they inputted in may have gluten in it. The investigators and research team will counsel patients on the possibility of the application occasionally not being able to accurately always identify gluten-free foods during the informed consent process, and it will be made clear that the families should be reading and understanding the gluten-free labels independently of the application as well(as it is the current clinical standard of care at BCH). The investigators and research team will also provide a reminder when starting the application, that while the application tries to be 100% updated, if families are concerned about gluten exposure, they should still independently read the labels as well.

Other: MyMedDiary; Other: Feedback on Gluten Exposure

No feedback on potential gluten exposure

OTHER

This group will still use the MyMedDiary application to input 3-day dietary recall, however there will not be feedback on whether they may have had a potential gluten exposure or if the food that they inputted in may have gluten in it.

Other: MyMedDiary

Interventions

MyMedDiary OTHER

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.

No feedback on potential gluten exposure; With Feedback on Gluten-Free Diet

Feedback on Gluten Exposure OTHER

The MyMedDiary Application will provide feedback on potential gluten exposure when participants input dietary record information into the application.

With Feedback on Gluten-Free Diet

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children (2-18 years of age) with a new diagnosis of celiac disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Instructor

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 25, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share