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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years

Able to provide informed consent

Established diagnosis of IBD determined by treating physician

Not in acute flare

Disqualifiers

Short bowel syndrome

High ostomy output

Intestinal strictures

Pregnancy or breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • MyIBDDiet app

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Control Crossover ArmActive comparator 1 intervention
Group B: MyIBDDiet usersExperimental treatment 1 intervention

Trial outcomes

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

Sponsors and contacts

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