Trial reportJournal of medical Internet research2021
A Novel Mobile App (Heali) for Disease Treatment in Participants With Irritable Bowel Syndrome: Randomized Controlled Pilot Trial.
Trial report in Journal of medical Internet research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04256551 (Effects of a Novel Machine Learning Mobile App on Diet Adherence in Individuals Following the Low Fodmap Diet), which is not on this map. Cited by 17 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effects of a Novel Machine Learning Mobile App on Diet Adherence in Individuals Following the Low Fodmap Diet: A Randomized Controlled Trial
Who cites it
17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 29 citations in OpenAlex.
- Digital Health Interventions Are Effective for Irritable Bowel Syndrome Self-Management: A Systematic Review.Digestive diseases and sciences · 2025Pooled it
- mHealth Intervention for Improving Pain, Quality of Life, and Functional Disability in Patients With Chronic Pain: Systematic Review.JMIR mHealth and uHealth · 2023Pooled it
- Randomized Controlled Trials of Artificial Intelligence in Clinical Practice: Systematic Review.Journal of medical Internet research · 2022Pooled it
- Long-Term Effects of a Web-Based Low-FODMAP Diet Versus Probiotic Treatment for Irritable Bowel Syndrome, Including Shotgun Analyses of Microbiota: Randomized, Double-Crossover Clinical Trial.Journal of medical Internet research · 2021Trial
- The Analytical Framework of Clinical Trials Evaluating Clinical Outcomes of Artificial Intelligence-Based Digital Health Interventions: A Systematic Literature Review.Journal of market access & health policy · 2026Review
- Evaluating a mobile-enhanced cognitive behavioral therapy program for university students with irritable bowel syndrome.Internet interventions · 2026Article
- Reframing precision nutrition in irritable bowel syndrome: a mechanism-informed conceptual framework for responder prediction and clinical translation.Frontiers in immunology · 2026Review
- The Use of Artificial Intelligence (AI) to Support Dietetic Practice Across Primary Care: A Scoping Review of the Literature.Nutrients · 2025Article
- Dietary management of irritable bowel syndrome: considerations, challenges, and solutions.The lancet. Gastroenterology & hepatology · 2024Review
- Work-related problems and the psychosocial characteristics of individuals with irritable bowel syndrome: an updated literature review.BioPsychoSocial medicine · 2024Review
- DOMINO trialTherapeutic advances in gastroenterology · 2024Article
- Gut liver brain axis in diseases: the implications for therapeutic interventions.Signal transduction and targeted therapy · 2023Review
- Article
- A preliminary study of further attempt at the development, testing and application of an independent primary screening stool card.Scientific reports · 2022Article
- Optimal Design of Clinical Trials of Dietary Interventions in Disorders of Gut-Brain Interaction.The American journal of gastroenterology · 2022Review
- Food Literacy and Its Associated Factors in Non-Dialysis Patients with Chronic Kidney Disease in China: A Cross-Sectional Study.Patient preference and adherence · 2022Article
- Understanding the user: Patients' perception, needs, and concerns of health apps for chronic constipation.Digital healthArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA diet high in fermentable, oligo-, di-, monosaccharides and polyols (FODMAPs) has been shown to exacerbate symptoms of irritable bowel syndrome (IBS). Previous literature reports 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 the information given by health care providers is often generalized and nonspecific, requiring them to search for supplementary information to fit their needs.
objectiveThe aim of our study was to determine whether Heali, a novel artificial intelligence dietary mobile app can 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.
methodsParticipants were randomized into 2 groups: the control group (CON), in which participants received educational materials, and the experimental group (APP), in which participants received access to the mobile app and educational materials. Over the course of this unblinded online trial, all participants completed a battery of 5 questionnaires at baseline and at the end of the trial to document IBS symptoms, quality of life, LFD knowledge, and LFD adherence.
resultsWe enrolled 58 participants in the study (29 in each group), and 25 participants completed the study in its entirety (11 and 14 for the CON and APP groups, respectively). Final, per-protocol 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=.04). Reduction in total IBS symptom severity score was 24% greater for the APP group versus the CON group. Although this did not achieve significance (-170 vs -138 respectively; P=.37), the reduction in the subscore for bowel habit dissatisfaction was 2-fold greater for the APP group than for the CON group (P=.05).
conclusionsThis initial study provides preliminary evidence that Heali may provide therapeutic benefit to its users, specifically improvements in quality of life and bowel habits. Although this study was underpowered, findings from this study warrant further research in a larger sample of participants to test the efficacy of Heali app use to improve outcomes for patients with IBS.
trial registrationClinicalTrials.gov NCT04256551; https://clinicaltrials.gov/ct2/show/NCT04256551.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.