Inflammatory Bowel Disease (IBD)NCT06683105
Clinical Investigation of MYIBDDiet App Developed for Inflammatory Bowel Disease (IBD) Patients to Self-manage Their Diet
A study testing MyIBDDiet app in people with Inflammatory Bowel Disease (IBD), run by University of Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD)
- What is being tested?
- MyIBDDiet app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 15 Mar 2026to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Zeidler Ledcor Centre, University of Alberta
Edmonton, Alberta, T6G 2X8
Karen Wong, MD, FRCPC, 780-492-8691 ext. 5, kwong3@ualberta.ca
About this study
Official title: A Pilot Randomized Trial Investigating the MyIBDDiet App to Improve Self-management of an Anti-inflammatory Diet for Individuals With Inflammatory Bowel Disease
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.
Read the detailed description
(Background): Inflammatory bowel disease (IBD), encompassing Crohn's disease and ulcerative colitis affects various segments of the gastrointestinal tract. Although this is a chronic illness, patients may experience periods of active inflammation and inactive disease or remission. At diagnosis, patients commonly enquire about what they should not be eating or avoiding. In the past, advice was limited to vague recommendations to "avoid the foods that bother participants" due to lack of research data to support a specific diet as beneficial.
The etiopathogenesis of IBD is thought to involves genetic predisposition, an altered composition and function of the intestinal microbiome, and a dysregulated immune. Diet has been shown to play a role in modulating the intestinal microbiome. There is now growing evidence to support the role of diet in in the management of IBD and recent guidelines have made more concrete recommendations for Mediterranean diet and avoidance of ultra-processed foods.
Although gastroenterologists may be aware and able to advice patients on the type of diet, few would have the expertise or time to provide specific details of the foods that are allowed or excluded in these diets. Not all patients will have access to a dietician and those who have access to a consultation will not have regular reinforcement of the concepts discussed.
The investigators therefore propose a digital solution to bridge the gap in care and allow for daily reinforcement of nutrition knowledge to help patients adhere to a healthy eating pattern. The MyIBDDiet app is designed to allow for tracking of food intake including preparation method, added fats and food processing with immediate messaging feedback on whether the food item should be consumed more often or less often. Symptom tracking will allow patients to correlate how they felt to their food intake. Additionally, further education and resources will be provided in the form of short videos or visual tools. These resources will be developed in response to user requests.
In this randomized pilot trial study, the investigators aim to conduct a clinical investigation to evaluate the effects of the the intervention of using the educational diet tracking app (MyIBDDiet).
(Purpose): The investigators aim to evaluate the MyIBDDiet app, designed to improve self-management of a healthy eating pattern.
(Hypothesis): It is hypothesized that diet plays a role in modulating the intestinal microbiome. A Western diet high in saturated fat, sugar and processed foods contributes to intestinal microbiome dysbiosis and has been implicated in the pathogenesis of IBD. Conversely, an anti-inflammatory pattern of eating (e.g., the Mediterranean diet) with concomitant reduction in processed foods has recently been cited by the American Gastroenterology Association as an adjunct to inactive states of IBD.
Majority (85.4%) of individuals living with IBD believe diet is implicated in disease relapse. A paucity of established dietary guidance has led patients with IBD to self-impose dietary restrictions, thus further increasing risk of malnutrition. Furthermore, while larger centers are more likely to be associated with dedicated nutrition professionals, most with IBD may be faced with navigating nutrition misinformation associated with random websites and the IBD community, itself.
(Justification): Mobile health applications (apps) providing self-managed, evidenced-based diet and lifestyle programs are emerging for the IBD population. While many IBD-related apps exist, some of the apps focus solely on tracking without providing education while others provide recipes or therapeutic diets that require coaching. Few focus on diet education or self-management. As such, the investigators aim to develop a nutrition app that delivers up-to-date, evidenced-based diet information in a format that follows principles of adult learning. Newly developed electronic resources and videos will provide education on an anti-inflammatory pattern of eating, fiber and the intestinal microbiome, food additives and emulsifiers and practical substitutions in a restaurant setting will be made available in the app. Our goal is to expand beyond surface learning (i.e. Videos/handouts) to try to achieve a deeper level of understanding by having patients categorize their food intake while tracking with immediate feedback on the rationale behind the recommendation to choose the item more or less often.
By integrating videos, tutorials, and patient entries, MyIBDDiet app combines clinical advice with patient independence, and empowerment.
(Objectives): The objectives include evaluating the usability and acceptability of the app in improving diet quality and diet knowledge.
- Conditions
- Inflammatory Bowel Disease (IBD)
- Being tested
- MyIBDDiet app
- Keywords
- Inflammatory Bowel Disease (IBD), Crohn's disease, Ulcerative colitis, Self-management, Malnutrition, Mediterranean diet, Mobile health applications
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyIBDDiet appOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Crossover Arm | Active comparator | This group will not use the app for the first 30 days, then begin using it for the following 30 days. Receives: Other: MyIBDDiet app |
| MyIBDDiet users | Experimental | This group will use the MyIBDDiet app for 60 days and compared with the control group. Receives: Other: MyIBDDiet app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of MyIBDDiet App
Determined by MAUQ scores (mobile health app usability questionnaire) and semi-structured interview responses
Measured: Through study completion - 60 days
Acceptability
Determined by TFA questionnaire (Theoretical Framework of Acceptability questionnaire) and semi-structured interview responses
Measured: Through study completion - 60 days
Secondary outcomes (2)
Quality of live
Quality of life will be assessed by European Quality of Life Five Dimension (EQ-5D) questionnaire
Measured: Through study completion - 60 days
Diet Quality
Change in diet quality before and after using MyIBDDiet App assessed using the Mini-EAT tool and Healthy Eating Index (HEI)
Measured: Through study completion - 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start15 Mar 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683105
- Sponsor's protocol ID
- Pro00141681
- Status last verified
- May 2026
- First submitted
- 5 Nov 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36771288Gold 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.
PubMed 37811532Godala 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.
PubMed 37240560Sekhon 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.
PubMed 35232455Balestrieri 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.
PubMed 32023881Kaur R, van Diepen K, Raiesdana S, Chappell KD, Ajibulu L, Gozdzik M, Halloran B, Hoentjen F, Kroeker KI, Peerani F, Prado CM, Kao D, Wong K. A pilot randomized trial on the usability and acceptability of an app (MyIBDDiet) to improve the self-management of anti-inflammatory diet for individuals with inflammatory bowel disease: A protocol paper. PLoS One. 2026 Jul 2;21(7):e0353123. doi: 10.1371/journal.pone.0353123. eCollection 2026.
PubMed 42391282
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Trial Investigating the MyIBDDiet App to Improve Self-management of an Anti-inflammatory Diet for Individuals With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06683105
- Acronym / sponsor ID
- Pro00141681
- Conditions
- Inflammatory Bowel Disease (IBD)
- Keywords
- Inflammatory Bowel Disease (IBD), Crohn's disease, Ulcerative colitis, Self-management, Malnutrition, Mediterranean diet, Mobile health applications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
(Background): Inflammatory bowel disease (IBD), encompassing Crohn's disease and ulcerative colitis affects various segments of the gastrointestinal tract. Although this is a chronic illness, patients may experience periods of active inflammation and inactive disease or remission. At diagnosis, patients commonly enquire about what they should not be eating or avoiding. In the past, advice was limited to vague recommendations to "avoid the foods that bother participants" due to lack of research data to support a specific diet as beneficial.
The etiopathogenesis of IBD is thought to involves genetic predisposition, an altered composition and function of the intestinal microbiome, and a dysregulated immune. Diet has been shown to play a role in modulating the intestinal microbiome. There is now growing evidence to support the role of diet in in the management of IBD and recent guidelines have made more concrete recommendations for Mediterranean diet and avoidance of ultra-processed foods.
Although gastroenterologists may be aware and able to advice patients on the type of diet, few would have the expertise or time to provide specific details of the foods that are allowed or excluded in these diets. Not all patients will have access to a dietician and those who have access to a consultation will not have regular reinforcement of the concepts discussed.
The investigators therefore propose a digital solution to bridge the gap in care and allow for daily reinforcement of nutrition knowledge to help patients adhere to a healthy eating pattern. The MyIBDDiet app is designed to allow for tracking of food intake including preparation method, added fats and food processing with immediate messaging feedback on whether the food item should be consumed more often or less often. Symptom tracking will allow patients to correlate how they felt to their food intake. Additionally, further education and resources will be provided in the form of short videos or visual tools. These resources will be developed in response to user requests.
In this randomized pilot trial study, the investigators aim to conduct a clinical investigation to evaluate the effects of the the intervention of using the educational diet tracking app (MyIBDDiet).
(Purpose): The investigators aim to evaluate the MyIBDDiet app, designed to improve self-management of a healthy eating pattern.
(Hypothesis): It is hypothesized that diet plays a role in modulating the intestinal microbiome. A Western diet high in saturated fat, sugar and processed foods contributes to intestinal microbiome dysbiosis and has been implicated in the pathogenesis of IBD. Conversely, an anti-inflammatory pattern of eating (e.g., the Mediterranean diet) with concomitant reduction in processed foods has recently been cited by the American Gastroenterology Association as an adjunct to inactive states of IBD.
Majority (85.4%) of individuals living with IBD believe diet is implicated in disease relapse. A paucity of established dietary guidance has led patients with IBD to self-impose dietary restrictions, thus further increasing risk of malnutrition. Furthermore, while larger centers are more likely to be associated with dedicated nutrition professionals, most with IBD may be faced with navigating nutrition misinformation associated with random websites and the IBD community, itself.
(Justification): Mobile health applications (apps) providing self-managed, evidenced-based diet and lifestyle programs are emerging for the IBD population. While many IBD-related apps exist, some of the apps focus solely on tracking without providing education while others provide recipes or therapeutic diets that require coaching. Few focus on diet education or self-management. As such, the investigators aim to develop a nutrition app that delivers up-to-date, evidenced-based diet information in a format that follows principles of adult learning. Newly developed electronic resources and videos will provide education on an anti-inflammatory pattern of eating, fiber and the intestinal microbiome, food additives and emulsifiers and practical substitutions in a restaurant setting will be made available in the app. Our goal is to expand beyond surface learning (i.e. Videos/handouts) to try to achieve a deeper level of understanding by having patients categorize their food intake while tracking with immediate feedback on the rationale behind the recommendation to choose the item more or less often.
By integrating videos, tutorials, and patient entries, MyIBDDiet app combines clinical advice with patient independence, and empowerment.
(Objectives): The objectives include evaluating the usability and acceptability of the app in improving diet quality and diet knowledge.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Crossover Arm | Active comparator | Other: MyIBDDiet appThis group will not use the app for the first 30 days, then begin using it for the following 30 days. |
| MyIBDDiet users | Experimental | Other: MyIBDDiet appThis group will use the MyIBDDiet app for 60 days and compared with the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years
- Able to provide informed consent
- Established diagnosis of IBD determined by treating physician
- Not in acute flare
- Not pregnant
Key exclusion criteria (10 listed)
- Short bowel syndrome
- High ostomy output
- Intestinal strictures
- Pregnancy or breastfeeding
- Malnutrition (evaluated by Canadian Nutrition Screening Tool (CNST) )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyIBDDiet appParticipants 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. | Other | Control Crossover Arm, MyIBDDiet users |
Primary outcome
Usability of MyIBDDiet App
Time frame: Through study completion - 60 days
Determined by MAUQ scores (mobile health app usability questionnaire) and semi-structured interview responses
Acceptability
Time frame: Through study completion - 60 days
Determined by TFA questionnaire (Theoretical Framework of Acceptability questionnaire) and semi-structured interview responses
2 secondary outcomes
Quality of live
Time frame: Through study completion - 60 days
Diet Quality
Time frame: Through study completion - 60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Results publication: PubMed 36771288Gubatan 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.
- Results publication: PubMed 37811532Gold 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.
- Results publication: PubMed 37240560Godala 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.
- Results publication: PubMed 35232455Sekhon 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.
- Results publication: PubMed 32023881Balestrieri 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.
- Derived from this study: PubMed 42391282Kaur R, van Diepen K, Raiesdana S, Chappell KD, Ajibulu L, Gozdzik M, Halloran B, Hoentjen F, Kroeker KI, Peerani F, Prado CM, Kao D, Wong K. A pilot randomized trial on the usability and acceptability of an app (MyIBDDiet) to improve the self-management of anti-inflammatory diet for individuals with inflammatory bowel disease: A protocol paper. PLoS One. 2026 Jul 2;21(7):e0353123. doi: 10.1371/journal.pone.0353123. eCollection 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyIBDDiet app in people with Inflammatory Bowel Disease (IBD), run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Wong, MD, FRCPC (780-492-8691 ext. Ext 5, kwong3@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of MyIBDDiet App (time frame: Through study completion - 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06683105, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.