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

N/ANot Yet RecruitingNCT07192874

Boston Children's Hospital120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

120

Conditions

Celiac Disease in Children

Interventions

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 6 MONTHS on a GFD

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

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).

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)

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

Time frame: 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.

Time frame: 6 months