ClinicalTrials.gg
RecruitingNCT06683105Updated May 7, 2026

Clinical Investigation of MYIBDDiet App Developed for Inflammatory Bowel Disease (IBD) Patients to Self-manage Their Diet

An interventional study of MyIBDDiet app in Inflammatory Bowel Disease (IBD), sponsored by University of Alberta. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by University of Alberta · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 11 studies in Inflammatory Bowel Diseases by University of Alberta — 3 open to participants now, 3 under way, none of them phase 3. Inflammatory Bowel Diseases · University of Alberta.

Started
2026
with 1 other
No phase
4 of 11
2 open now
Registered
10th of 11
by date

Among the 11 studies in Inflammatory Bowel Diseases by University of Alberta, this one is one of 2 that started in 2026, is one of 4 with no phase, and was the 10th registered.

Inflammatory Bowel Diseases

1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 425 are open to participants now.

Browse Inflammatory Bowel Diseases studies →

Open to participants now

3 of the 11 studies in Inflammatory Bowel Diseases by University of Alberta are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Where they have run

Who these studies take

Of the 277 Inflammatory Bowel Diseases studies recruiting now, 133 (48%) set no upper age limit and 117 (42%) stop at 75 or younger; 76 take children under 18; 61 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 11 studies in Inflammatory Bowel Diseases by University of Alberta, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Inflammatory Bowel Disease (IBD)

Keywords

  • Inflammatory Bowel Disease (IBD)
  • Crohn's disease
  • Ulcerative colitis
  • Self-management
  • Malnutrition
  • Mediterranean diet
  • Mobile health applications
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. ≥18 years
  2. Able to provide
  3. Established diagnosis of IBD determined by treating physician
  4. Not in acute flare
  5. Not pregnant
  6. Willing and able to comply with all required study procedures

Exclusion criteria

Exclusion Criteria:

  1. Short bowel syndrome
  2. High ostomy output
  3. Intestinal strictures
  4. Pregnancy or breastfeeding
  5. Malnutrition (evaluated by Canadian Nutrition Screening Tool (CNST) )
  6. Conditions requiring dietary restrictions (e.g. Celiac disease, kidney disease, diabetes, eosinophilic esophagitis)
  7. Have other conditions that may require low fibre diet such as irritable bowel syndrome, gastroparesis.
  8. Currently on a therapeutic diet
  9. Already on a diet for IBD or using diet tool for IBD (e.g. Mediterranean or anti-inflammatory diet)
  10. Active
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Control Crossover Arm

    This group will not use the app for the first 30 days, then begin using it for the following 30 days.

    Other: MyIBDDiet app

  • Experimental
    MyIBDDiet users

    This group will use the MyIBDDiet app for 60 days and compared with the control group.

    Other: MyIBDDiet app

Interventions

  • OtherMyIBDDiet app

    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.

06

What researchers measure

Primary outcomes

  1. Usability of MyIBDDiet App

    Determined by MAUQ scores (mobile health app usability questionnaire) and semi-structured interview responses

    Time frame: Through study completion - 60 days

  2. Acceptability

    Determined by TFA questionnaire (Theoretical Framework of Acceptability questionnaire) and semi-structured interview responses

    Time frame: Through study completion - 60 days

Secondary outcomes

  1. Quality of live

    Quality of life will be assessed by European Quality of Life Five Dimension (EQ-5D) questionnaire

    Time frame: Through study completion - 60 days

  2. Diet Quality

    Change in diet quality before and after using MyIBDDiet App assessed using the Mini-EAT tool and Healthy Eating Index (HEI)

    Time frame: Through study completion - 60 days

Other outcomes

  1. Change in adherence to / knowledge of Mediterranean diet

    Determined with Mediterranean Diet Serving Score (MDSS)

    Time frame: Through study completion - 60 days

  2. Change in intake of highly processed foods

    Change in intake of highly processed foods as determined by Automated Self-Administered 24-Hour Dietary Recall (ASA24®) (Dietary Assessment) Tool and NOVA classification. (NOVA classification groups foods according to the nature, extent and purpose of the industrial processing they undergo).

    Time frame: Through study completion - 60 days

07

Study locations

1 of 1 sites recruiting
  • Zeidler Ledcor Centre, University of Alberta
    Edmonton, Alberta T6G 2X8, Canada
    Recruiting
08

References and documents

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 36771288 ↗
  • Gold 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 37811532 ↗
  • Godala 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 37240560 ↗
  • Sekhon 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 35232455 ↗
  • Balestrieri 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 32023881 ↗
  • Kaur 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Dec 2028, 32 months after the start.

Of 282 non-industry interventional studies with no phase under Inflammatory Bowel Diseases, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 50. This study's planned 32 months is above that.

Counting every sponsor, half of 296 studies reached it within 27 months; a quarter within 14 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2024
First posted
Nov 12, 2024
StartActual
Mar 15, 2026
Primary completionEst.
Dec 1, 2028
CompletionEst.
Jun 1, 2029
Last update
May 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06683105
Responsible party
Sponsor
First posted
Nov 12, 2024
Start date
Mar 15, 2026
Primary completion
Dec 1, 2028 (estimated)
Completion
Jun 1, 2029 (estimated)
Last update
May 7, 2026

Study contacts

Karen Wong, MD, FRCPC
Contact
kwong3@ualberta.ca
780-492-8691 ext. Ext 5
Ravneet Kaur, M.Sc.
Contact
rkaur8@ualberta.ca
7802481034

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion