Diet Education App for Inflammatory Bowel Disease

Overseen By Somyeh Raiesdana, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Short bowel, Ostomy, Strictures, Malnutrition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the MyIBDDiet app can assist individuals with inflammatory bowel disease (IBD) in learning about healthy eating. Researchers seek to assess the app's usability and its effectiveness in enhancing users' understanding of good dietary habits compared to standard advice from a doctor. Participants will either use the app for 60 days or begin using it after 30 days without it, completing surveys about their experience. This trial suits adults diagnosed with IBD who are not experiencing a flare-up and are not currently following any specific diet plan. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance dietary management for IBD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it focuses on diet education, so it's unlikely that medication changes are required.

What prior data suggests that this app is safe for users with inflammatory bowel disease?

Research has shown that digital health apps, like the MyIBDDiet app, are generally safe and easy to use. In studies, apps designed for inflammatory bowel disease (IBD) have helped patients manage their condition without reports of harm. Many of these apps focus on self-care, enabling individuals to manage their health independently. They provide patients with health information and support.

No specific safety issues have been reported for the MyIBDDiet app itself. This app focuses on educating IBD patients about diet. As a digital tool rather than a medication, it carries a very low risk of negative effects. Overall, using the MyIBDDiet app is expected to be a safe experience for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MyIBDDiet app because it offers a fresh approach to managing Inflammatory Bowel Disease (IBD) through personalized dietary education. Unlike standard treatments that typically involve medications like anti-inflammatory drugs or immune system suppressors, this app empowers patients with tailored dietary advice to potentially reduce symptoms and improve quality of life. The app's unique feature is its ability to provide real-time, customized dietary guidance, which could help patients make informed food choices that align with their specific health needs. This innovative use of technology has the potential to transform IBD management by focusing on diet, a crucial but often underutilized aspect of treatment.

What evidence suggests that the MyIBDDiet app is effective for teaching healthy eating to patients with inflammatory bowel disease?

Studies have shown that mobile health apps can greatly assist people with inflammatory bowel disease (IBD). Research indicates that these apps help users track symptoms more effectively and facilitate communication with healthcare teams. A review of digital health tools found that they can effectively assist in managing IBD. In this trial, participants will either use the MyIBDDiet app or follow the standard of care. The MyIBDDiet app is designed to educate users about healthy eating, which is crucial for managing IBD symptoms. Early findings suggest that apps like this can enhance users' understanding of healthy diet habits. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for patients with inflammatory bowel disease (IBD) who are interested in managing their diet through an educational app. The study seeks individuals willing to use the app for a month and provide feedback via surveys.

Inclusion Criteria

Not pregnant

My condition is currently stable.

Willing and able to comply with all required study procedures

Exclusion Criteria

Conditions requiring dietary restrictions (e.g. Celiac disease, kidney disease, diabetes, eosinophilic esophagitis)

I have a high output from my ostomy.

Pregnancy or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Observation

Standard of Care group does not use the app for the first 30 days, while the MyIBDDiet users group uses the app

4 weeks

1 visit (in-person) for baseline assessment

Treatment

Standard of Care group begins using the app, while MyIBDDiet users continue using the app

4 weeks

1 visit (in-person) for follow-up assessment

Follow-up

Participants are monitored for changes in diet quality and adherence to the Mediterranean diet

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MyIBDDiet app

Trial Overview

The MyIBDDiet app, designed to educate IBD patients on healthy eating habits, is being tested for ease of use and effectiveness compared to standard dietary advice from doctors.

How Is the Trial Designed?

Group I: MyIBDDiet users Experimental Treatment 1 Intervention

This group will use the MyIBDDiet app for 60 days and compared with the standard of care group.

Group II: Standard of Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

The 'myfood24 Healthcare' app was found to be acceptable for both patients and healthcare professionals in a feasibility study involving 48 participants from weight management and gastroenterology surgery programs.

Compliance with the app was reasonable, with 50% of users recording their dietary intake for four or more days, indicating potential for effective dietary monitoring and support in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of myfood24 Healthcare and Mathematical Diet Optimisation in Clinical Populations: A Pilot Feasibility Randomised Controlled Trial. Threapleton, DE., Beer, SL., Foley, DJ., et al.[2023]

A study involving 100 patients with inflammatory bowel disease showed that using smartphone apps for monitoring symptoms and biomarkers is as effective as standard face-to-face care in maintaining quality of life and symptom management over 12 months.

The use of smartphone apps significantly reduced the number of outpatient appointments needed, indicating a more efficient management approach for patients in remission, particularly for those with mild-to-moderate disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Noninferiority Randomized Clinical Trial of the Use of the Smartphone-Based Health Applications IBDsmart and IBDoc in the Care of Inflammatory Bowel Disease Patients. McCombie, A., Walmsley, R., Barclay, M., et al.[2021]

Out of 1,512 mobile health apps identified for inflammatory bowel disease (IBD), only six met the criteria for quality and relevance, highlighting a gap in effective self-management tools for diet and lifestyle.

The apps 'My IBD Care: Crohn's and Colitis' and 'LyfeMD' received the highest ratings for quality and functionality, including behavior tracking, suggesting they may be beneficial for patients managing IBD, but their actual impact on health outcomes needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification and Evaluation of Mobile Applications for Self-Management of Diet and Lifestyle for Patients with Inflammatory Bowel Disease. Gold, SL., Chiew, BA., Rajagopalan, V., et al.[2023]

Diet plays a significant role in managing inflammatory bowel diseases (IBD), and personalized dietary strategies may help improve symptoms and nutritional status for individual patients.

The review emphasizes the need for tailored nutritional advice based on the unique clinical and molecular characteristics of IBD, suggesting that personalized approaches could lead to better management of inflammation and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Dietary Regimens for Inflammatory Bowel Disease: Current Knowledge and Future Perspectives. Wellens, J., Vissers, E., Matthys, C., et al.[2023]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06683105

Clinical Investigation of MYIBDDiet App Developed for ...

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12363004/

Mobile health technologies in inflammatory bowel disease

Users can track symptoms weekly, are able to contact their healthcare team via secure messaging on the app, and have access to IBD-related ...

3.

thelancet.com

thelancet.com/journals/landig/article/PIIS2589-7500%2824%2900290-5/fulltext

Efficacy of digital health technologies in the management ...

Efficacy of digital health technologies in the management of inflammatory bowel disease: an umbrella review.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11725021/

Developing Mobile Health Applications for Inflammatory ...

The results of the present study showed that 100% of the applications designed for patients with IBD were aimed at treatment, 83% were for self-management,6,16, ...

5.

app.trialscreen.org

app.trialscreen.org/trials/clinical-investigation-myibddiet-app-developed-inflammatory-bowel-disease-trial-nct06683105

Clinical Investigation of MyIBDDiet App for IBD Patients

Benefits: Participation in this study may help improve your understanding of healthy eating patterns for managing IBD, as well as provide valuable feedback to ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6077306/

What's app? Electronic health technology in inflammatory ...

eHealth technology has the potential to improve IBD care. Remote monitoring of IBD, through patient reported outcomes, with direct connection to the ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1386505623002678

Review and content analysis of mobile apps for ...

This study evaluated mobile apps developed for the IBD community and rated the quality of these apps to provide a roadmap for future development.