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

Boston Children's Hospital

Status: Not yet enrolling

Conditions: Celiac Disease in Children

Treatments: Other: MyMedDiary; Other: Feedback on Gluten Exposure

Study type: Interventional

Funder types: Other

Identifiers

NCT07192874

IRB-P00051858

Details and patient eligibility

About

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).

Enrollment: 120 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

With Feedback on Gluten-Free Diet

Experimental group

Description:

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.

Treatment:

Other: Feedback on Gluten Exposure

Other: MyMedDiary

No feedback on potential gluten exposure

Other group

Description:

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.

Treatment:

Other: MyMedDiary