DIGITAL Study: Evaluating "MyMedDiary" as a Tool for Improving Gluten-Free Diet Adherence and Knowledge in Children With Newly Diagnosed Celiac Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Differences in mean percentage estimates of ultra-processed foods within the overall diet(via the NOVA classification of ultraprocessed foods)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (2-18 years of age) with a new diagnosis of celiac disease
排除标准
- •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
结局指标
主要结局
Differences in mean percentage estimates of ultra-processed foods within the overall diet(via the NOVA classification of ultraprocessed foods)
时间窗: 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.
Differences in mean percentage estimates of ultra-processed foods within the overall diet(via the NOVA classification of ultraprocessed foods)
时间窗: 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.
次要结局
- 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)
- 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)
- Differences in GFD adherence scores via Celiac Dietary Adherence Test (CDAT)(6 months)
- Differences in GFD Knowledge scores via GFD Knowledge Scale(6 months)
研究者
Nan Du
Principal Investigator, Clinical Instructor
Boston Children's Hospital