Celiac Disease
Conditions
Brief summary
This is a prospective randomized controlled trial investigating the impact of educational bidirectional text message reminders on gluten free diet adherence among adolescents and young adults with celiac disease age 12-24. Participants will complete a series of online questionnaires assessing quality of life, patient activation, celiac symptoms, and self reported dietary adherence at the beginning and end of the study. Participants will also have their blood drawn to measure Tissue Transglutaminase IgA (TTG IgA) antibody and Deamidated Gliadin Peptide IgA (DGP IgA) at the beginning and end of the study. Lab draws can be done locally, and are at no cost to the participant. Patients are randomized to the intervention or control group based on enrollment TTG IgA. Intervention group receives 45 unique text messages over the 3 month study. A gift card is provided for participation in the study.
Interventions
BEHAVIORALEducational Text Message Reminders
45 unique text messages designed by the Stanford Pediatric Gastroenterology physicians and nutritionists
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* Age 12-24 * Celiac disease diagnosed by a gastroenterologist at least 1 year prior to enrollment * Participant with ability to read email and text messages in English * Access to a mobile phone * Unlimited text messaging plan or agreement to receive 45 text messages for the study
Exclusion criteria
* Participant inability to answer survey questions and text prompts in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tissue Transglutaminase IgA (TTG IgA) | 3 months | Percent change in TTG IgA for each participant pre and post study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Deamidated Gliadin Peptide IgA (DGP IgA) | 3 months | Percent change in DGP IgA for each participant pre and post study period |
| NIH-PROMIS quality of life score | 3 months | Change in NIH-PROMIS quality of life questionnaire score pre and post study period |
| Patient Activation Measure (PAM) score | 3 months | Change in Patient Activation Measure (PAM) questionnaire score pre and post study period |
| Patient-reported dietary adherence (CDAT) score | 3 months | Change in patient-reported dietary adherence (CDAT) questionnaire score pre and post study period |
| Patient-reported celiac disease symptom measure (CDI) score | 3 months | Change in patient-reported celiac disease symptom measure (CDI) questionnaire score pre and post study period |
Countries
United States
Outcome results
None listed