Celiac Disease in ChildrenDIGITALNCT07192874
Dietary Intervention Using a Gluten-free App to Improve Tracking, Adherence, and Learning(DIGITAL) Study
A study testing MyMedDiary and Feedback on Gluten Exposure in people with Celiac Disease in Children, run by Boston Children's Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Celiac Disease in Children
- What is being tested?
- MyMedDiary and Feedback on Gluten Exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children (2-18 years of age) with a new diagnosis of celiac disease
Who cannot join
- 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
About this study
Official title: DIGITAL Study: Evaluating "MyMedDiary" as a Tool for Improving Gluten-Free Diet Adherence and Knowledge in Children With Newly Diagnosed Celiac Disease
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
- Being tested
- MyMedDiary, Feedback on Gluten Exposure
- Keywords
- CELIAC
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyMedDiaryOther
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 ExposureOther
The MyMedDiary Application will provide feedback on potential gluten exposure when participants input dietary record information into the application.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: MyMedDiary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Estimates of the dietary relative contributions of NOVA groups will be obtained by MyMedDiary with parallel paper based manual recall and manual dietary classification at 4 different time point (at initial entry/diagnostic endoscopy, 2-month, 4-month and 6-month).
Measured: 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)
Differences in GFD Adherence scores in families who received feedback on potential gluten exposure in diet compared to families who did not receive feedback. The CDAT questionnaire consists of 7 items on a 5-point Likert scale, and the sum of the numeric values assigned to the answers provides a score ranging from 7 to 35 points. The interpretation was as following: 7 points-excellent GFD adherence; 8-12 points-very good GFD adherence; 13-17 points-insufficient/inadequate GFD adherence, and >17 points-poor GFD adherence
Measured: 6 months
Differences in GFD Knowledge scores via GFD Knowledge Scale
Differences in GFD knowledge scores in families who received feedback on potential gluten exposure in diet compared to families who did not receive feedback. The Gluten-Free Diet Knowledge Scale, a standardized and reliable questionnaire where participants categorize 17 listed foods as either "allowed", "foods to question" or "not allowed" in the gluten free diet, will be used to quantify the participants' knowledge about GFD. One point is award for each correct answer for a maximum total score of 17, thus higher scores suggest greater knowledge.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nan Du, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192874
- Sponsor's protocol ID
- IRB-P00051858
- Acronym
- DIGITAL
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIGITAL Study: Evaluating "MyMedDiary" as a Tool for Improving Gluten-Free Diet Adherence and Knowledge in Children With Newly Diagnosed Celiac Disease
- ClinicalTrials.gov ID
- NCT07192874
- Acronym / sponsor ID
- DIGITAL / IRB-P00051858
- Conditions
- Celiac Disease in Children
- Keywords
- CELIAC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Feedback on Gluten-Free Diet | Experimental | Other: MyMedDiary, Other: Feedback on Gluten ExposureParticipants 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. |
| No feedback on potential gluten exposure | Other | Other: MyMedDiaryThis 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. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children (2-18 years of age) with a new diagnosis of celiac disease
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyMedDiarymyMedDiary 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 | No feedback on potential gluten exposure, With Feedback on Gluten-Free Diet |
| Feedback on Gluten ExposureThe MyMedDiary Application will provide feedback on potential gluten exposure when participants input dietary record information into the application. | Other | With Feedback on Gluten-Free Diet |
Primary outcome
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
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MyMedDiary and Feedback on Gluten Exposure in people with Celiac Disease in Children, run by Boston Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.