Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Sep 4, 2020
Open Peer Review Period: Sep 4, 2020 - Oct 30, 2020
Date Accepted: Jan 15, 2021
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Effects of Heali, a Novel Mobile Application, on Disease Treatment in Participants with Irritable Bowel Syndrome: A Randomized Controlled Trial
ABSTRACT
Background:
A diet high in fermented, oligo-, di-, monosaccharide, and polyols (FODMAPs) has been shown to exacerbate symptoms of irritable bowel syndrome (IBS). Previous literature has shown significant improvement in IBS symptoms with initiation of a low FODMAP diet (LFD) and monitored reintroduction. However, dietary adherence to the LFD is difficult, with patients stating that information provided by healthcare providers is often generalized and nonspecific requiring them to search for supplementary information to fit their needs.
Objective:
To determine whether Heali, a novel artificial intelligence dietary mobile application, will improve adherence to the LFD, IBS symptom severity and quality of life outcomes, in adults with IBS or IBS-like symptoms over a 4-week period.
Methods:
Participants were randomized into two groups: control (CON), participants received educational materials, and experimental (APP), participants received access to the mobile application as well as educational materials. Over the course of this unblinded online trial, all participants completed a battery of five questionnaires at baseline and at the end of the trial to document IBS symptoms, quality of life, LFD diet knowledge, and LFD diet adherence.
Results:
58 participants were enrolled in the study (n=29 in each group), and 25 participants completed the study in its entirety (n=11 and 14 for CON and APP respectively). Final analyses showed greater improvement in quality of life score for the APP group compared to the CON group (+31.1 and +11.8 respectively, P=.038). Reduction in total IBS symptoms severity score was 24% greater for the APP group vs. the CON group, though this did not achieve significance (-170 vs. -138 respectively, P>.05), the reduction in the sub-score ‘bowel habit dissatisfaction’ was 2-fold greater for the APP group in comparison to the CON group (P=.05).
Conclusions:
This initial study provides preliminary evidence that Heali may provide therapeutic benefit to its users, specifically improvements in quality of life and bowel habits. Findings from this study warrant further research in a larger sample of subjects to test the efficacy of Heali app use to improve outcomes for patients with IBS. Clinical Trial: The study was registered at clinicaltrials.gov (Identifier: NCT04256551).
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