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

NCT ID: NCT07192874

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

With Feedback on Gluten-Free Diet

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.

Group Type: EXPERIMENTAL

MyMedDiary

Intervention Type: 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.

Feedback on Gluten Exposure

Intervention Type: OTHER

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

No feedback on potential gluten exposure

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.

Group Type: OTHER

MyMedDiary

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Feedback on Gluten Exposure

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nan Du

Principal Investigator, Clinical Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IRB-P00051858

Identifier Type: -

Identifier Source: org_study_id