Clinical Investigation of MYIBDDiet App Developed for Inflammatory Bowel Disease (IBD) Patients to Self-manage Their Diet
A Pilot Randomized Trial Investigating the MyIBDDiet App to Improve Self-management of an Anti-inflammatory Diet for Individuals With Inflammatory Bowel Disease
1 other identifier
interventional
40
1 country
1
Brief Summary
The goal of this clinical trial is to learn if an app designed for diet education can help patients with inflammatory bowel disease (IBD) learn about healthy eating. The main question\[s\] it aims to answer are:
- Is the app easy to use?
- Is the app useful? Researchers will compare the diet app to see if it is better at teaching patients about a healthy diet than the standard information they may receive from their doctor. Participants will be asked to use the app for one month and answer surveys to see how easy the app is to use and if it leads to healthier eating.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2024
CompletedFirst Posted
Study publicly available on registry
November 12, 2024
CompletedStudy Start
First participant enrolled
March 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
May 7, 2026
May 1, 2026
2.7 years
November 5, 2024
May 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Usability of MyIBDDiet App
Determined by MAUQ scores (mobile health app usability questionnaire) and semi-structured interview responses
Through study completion - 60 days
Acceptability
Determined by TFA questionnaire (Theoretical Framework of Acceptability questionnaire) and semi-structured interview responses
Through study completion - 60 days
Secondary Outcomes (2)
Quality of live
Through study completion - 60 days
Diet Quality
Through study completion - 60 days
Other Outcomes (2)
Change in adherence to / knowledge of Mediterranean diet
Through study completion - 60 days
Change in intake of highly processed foods
Through study completion - 60 days
Study Arms (2)
Control Crossover Arm
ACTIVE COMPARATORThis group will not use the app for the first 30 days, then begin using it for the following 30 days.
MyIBDDiet users
EXPERIMENTALThis group will use the MyIBDDiet app for 60 days and compared with the control group.
Interventions
Participants in the Control crossover arm will be administered the intervention (using the app) for 30 days, and participants in the MYIBDDiet arm will use the app for 60 days.
Eligibility Criteria
You may qualify if:
- ≥18 years
- Able to provide informed consent
- Established diagnosis of IBD determined by treating physician
- Not in acute flare
- Not pregnant
- Willing and able to comply with all required study procedures
You may not qualify if:
- Short bowel syndrome
- High ostomy output
- Intestinal strictures
- Pregnancy or breastfeeding
- Malnutrition (evaluated by Canadian Nutrition Screening Tool (CNST) )
- Conditions requiring dietary restrictions (e.g. Celiac disease, kidney disease, diabetes, eosinophilic esophagitis)
- Have other conditions that may require low fibre diet such as irritable bowel syndrome, gastroparesis.
- Currently on a therapeutic diet
- Already on a diet for IBD or using diet tool for IBD (e.g. Mediterranean or anti-inflammatory diet)
- Active malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zeidler Ledcor Centre, University of Alberta
Edmonton, Alberta, T6G 2X8, Canada
Related Publications (5)
Gubatan J, Kulkarni CV, Talamantes SM, Temby M, Fardeen T, Sinha SR. Dietary Exposures and Interventions in Inflammatory Bowel Disease: Current Evidence and Emerging Concepts. Nutrients. 2023 Jan 22;15(3):579. doi: 10.3390/nu15030579.
PMID: 36771288RESULTGold SL, Chiew BA, Rajagopalan V, Lavallee CM. Identification and Evaluation of Mobile Applications for Self-Management of Diet and Lifestyle for Patients with Inflammatory Bowel Disease. J Can Assoc Gastroenterol. 2023 Sep 16;6(5):186-195. doi: 10.1093/jcag/gwad029. eCollection 2023 Oct.
PMID: 37811532RESULTGodala M, Gaszynska E, Durko L, Malecka-Wojciesko E. Dietary Behaviors and Beliefs in Patients with Inflammatory Bowel Disease. J Clin Med. 2023 May 14;12(10):3455. doi: 10.3390/jcm12103455.
PMID: 37240560RESULTSekhon M, Cartwright M, Francis JJ. Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions. BMC Health Serv Res. 2022 Mar 1;22(1):279. doi: 10.1186/s12913-022-07577-3.
PMID: 35232455RESULTBalestrieri P, Ribolsi M, Guarino MPL, Emerenziani S, Altomare A, Cicala M. Nutritional Aspects in Inflammatory Bowel Diseases. Nutrients. 2020 Jan 31;12(2):372. doi: 10.3390/nu12020372.
PMID: 32023881RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2024
First Posted
November 12, 2024
Study Start
March 15, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
June 1, 2029
Last Updated
May 7, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share