Dietary Intervention Using a Gluten-free App to Improve Tracking, Adherence, and Learning(DIGITAL) Study
- Conditions
- Celiac Disease in Children
- Registration Number
- NCT07192874
- Lead Sponsor
- Boston Children's Hospital
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Children (2-18 years of age) with a new diagnosis of celiac disease
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Differences in mean percentage estimates of ultra-processed foods within the overall diet(via the NOVA classification of ultraprocessed foods) 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.
- Secondary Outcome Measures
Name Time Method 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 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).
Differences in GFD adherence scores via Celiac Dietary Adherence Test (CDAT) 6 months 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
Differences in GFD Knowledge scores via GFD Knowledge Scale 6 months 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.