College of Health Solutions, Arizona State University, Phoenix, AZ, United States.
Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, United States.
J Med Internet Res. 2021 Mar 2;23(3):e24134. doi: 10.2196/24134.
BACKGROUND: A 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. OBJECTIVE: The 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. METHODS: Participants 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. RESULTS: We 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). 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. 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 REGISTRATION: ClinicalTrials.gov NCT04256551; https://clinicaltrials.gov/ct2/show/NCT04256551.
背景：高发酵、寡糖、二糖、单糖和多元醇（FODMAPs）的饮食已被证明会加重肠易激综合征（IBS）的症状。先前的文献报道，低 FODMAP 饮食（LFD）的起始和监测再引入可显著改善 IBS 症状。然而，LFD 的饮食依从性是困难的，患者表示，医疗保健提供者提供的信息通常是笼统和非特异性的，需要他们搜索补充信息以满足他们的需求。
目的：我们的研究旨在确定新型人工智能饮食移动应用程序 Heali 是否可以改善成人 IBS 或 IBS 样症状患者在 4 周内对 LFD 的依从性、IBS 症状严重程度和生活质量结果。
方法：参与者被随机分为 2 组：对照组（CON），参与者接受教育材料；实验组（APP），参与者可访问移动应用程序和教育材料。在这项非盲在线试验过程中，所有参与者在基线和试验结束时完成了一套 5 份问卷，以记录 IBS 症状、生活质量、LFD 知识和 LFD 依从性。
结果：我们招募了 58 名参与者参加这项研究（每组 29 名），其中 25 名参与者完成了整个研究（CON 组 11 名，APP 组 14 名）。最终，按方案分析显示，APP 组的生活质量评分改善优于 CON 组（分别为 31.1 和 11.8；P=.04）。APP 组的 IBS 总症状严重程度评分降低了 24%，而 CON 组降低了 17%。虽然这没有达到显著差异（分别为-170 与-138；P=.37），但 APP 组对肠道习惯不满意的亚评分降低了 2 倍，而 CON 组降低了 1 倍（P=.05）。
结论：这项初步研究提供了初步证据，表明 Heali 可能为其用户提供治疗益处，特别是在生活质量和肠道习惯方面。尽管这项研究的效力不足，但这项研究的结果需要在更大的参与者样本中进行进一步研究，以测试 Heali 应用程序使用改善 IBS 患者结局的疗效。
试验注册：ClinicalTrials.gov NCT04256551；https://clinicaltrials.gov/ct2/show/NCT04256551。
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