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临床试验/NCT04256551
NCT04256551已完成不适用

Effects of a Novel Machine Learning Mobile App on Diet Adherence in Individuals Following the Low Fodmap Diet: A Randomized Controlled Trial

Arizona State University1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2020年1月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1
主要终点
Rome IV

研究概览

简要总结

A high fermented, oligio-, di-, monosaccharide, and polyols (FODMAP) diet has been shown to exacerbate the symptoms of irritable bowel syndrome (IBS). Previous literature has shown significant improvement in IBS symptoms after adherence to a low FODMAP diet (LFD); hence, LFD is a viable treatment method for IBS and IBS-like symptoms. However, adherence to the LFD has proven to be difficult with participants stating that information provided by medical practitioners is generalized and nonspecific requiring them to search for supplementary information to fit their individual needs. Notably, studies that have used a combination of online and in-person methods for treatment have shown improved adherence to the LFD. The purpose of this study is to determine whether a novel machine learning dietary mobile application (ML-App) will improve adherence to the LFD compared to a standard online dietary intervention in populations with IBS or IBS-like symptoms over a 4 week period.

详细描述

Subjects will be residents of California or Arizona and recruited to the study via response to the study recruitment questionnaire advertised through online flyers, social media platforms (i.e., facebook and instagram), list serves, and recruitment services across all Arizona State University (ASU) campuses. This 6-week randomized controlled experimental study consists of a 4-week intervention period that immediately follows a 2-week baseline symptom monitoring period. The trial is conducted completely online. Data analyses will begin immediately once the trial is initiated and is expected to occur for up to one year after study completion. Following a 2-week monitoring period, participants will be randomized (via a number draw randomization method) into one of three groups: Machine Learning (ML) App + Registered Dietitian (RD) facilitator (ML-RD), ML mobile application (ML-App), or Standard Dietary Education (CON). The ML-RD group will be provided access to the Heali mobile application as well as a personal RD to provide nutrition support and answer any questions through a real-time messaging system within the mobile app. The ML-APP group receives access to the Heali mobile dietary application only. All groups will receive a link to resources regarding the LFD including an educational guide to the implementation of the elimination and reintroduction phases of the diet, a suitable/unsuitable food guide, 19 substitutes for unsuitable foods, a guide of example meals (i.e., breakfast-6 recipes, lunch-8 recipes, dinner-12 recipes, and snacks/beverages-13 recipes), and tips for reading labels and eating a balanced diet while following the LFD. The website is located at http://www.myginutrition.com/news.html and operated by the University of Michigan Health System.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •IBS-SSS score ≥ 175 (moderate to severe IBS)
  • •meet the Rome IV criteria for IBS of any type including those with IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), IBS mixed typed (IBS-M), or IBS unsubtyped (IBS-U), and had symptoms for the past 3 months or greater
  • •own an I-phone
  • •have not used a dietary application or elimination diet for IBS in the past 6 months
  • •must be willing to participate in the low FODMAP diet intervention over a 4-week period with a monitoring period of 2-weeks
  • •agree to complete online questionnaires as frequently as once per week from study start.

排除标准

  • •individuals with food allergies (not food intolerances)
  • •those with history of chronic disease (other than gastrointestinal dysfunction)
  • •nutrition student or professional
  • •prescription medication is permitted unless the medication is to treat IBS (which includes steroids).

研究组 & 干预措施

Machine Learning App + Registered Dietitian facilitator

Experimental

The ML-RD group will be provided access to the Heali mobile application as well as a personal RD to provide nutrition support and answer any questions through a real-time messaging system within the mobile app. Group will receive a link to resources regarding the Low FODMAP diet: website is located at http://www.myginutrition.com/news.html and operated by the University of Michigan Health System

干预措施: Heali mobile application + Registered Dietitian (Other)

Machine Learning App + Registered Dietitian facilitator

Experimental

The ML-RD group will be provided access to the Heali mobile application as well as a personal RD to provide nutrition support and answer any questions through a real-time messaging system within the mobile app. Group will receive a link to resources regarding the Low FODMAP diet: website is located at http://www.myginutrition.com/news.html and operated by the University of Michigan Health System

干预措施: Heali mobile application (Other)

Machine Learning App + Registered Dietitian facilitator

Experimental

The ML-RD group will be provided access to the Heali mobile application as well as a personal RD to provide nutrition support and answer any questions through a real-time messaging system within the mobile app. Group will receive a link to resources regarding the Low FODMAP diet: website is located at http://www.myginutrition.com/news.html and operated by the University of Michigan Health System

干预措施: Standard Dietary Education (Other)

Machine Learning App

Active Comparator

The ML-APP group receives access to the Heali mobile dietary application. Group will receive a link to resources regarding the Low FODMAP diet: website is located at http://www.myginutrition.com/news.html and operated by the University of Michigan Health System

干预措施: Heali mobile application (Other)

Machine Learning App

Active Comparator

The ML-APP group receives access to the Heali mobile dietary application. Group will receive a link to resources regarding the Low FODMAP diet: website is located at http://www.myginutrition.com/news.html and operated by the University of Michigan Health System

干预措施: Standard Dietary Education (Other)

Standard Dietary Education

Placebo Comparator

Group will receive a link to resources regarding the Low FODMAP diet: website is located at http://www.myginutrition.com/news.html and operated by the University of Michigan Health System

干预措施: Standard Dietary Education (Other)

结局指标

主要结局

Rome IV

时间窗: Change from Baseline at week 6

A diagnostic tool to determine severity of gastrointestinal dysfunction and the most updated method to diagnose IBS. Participants will complete the self-administered online survey. Based on the results of the survey, we will identify the IBS category. \[e.g., IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), IBS mixed typed (IBS-M), or IBS unsubtyped (IBS-U)\]

IBS-SSS

时间窗: Change from Baseline at week 6

A symptom severity screener validated by Francis et al. The IBS-SSS is a short survey filled out by participants which categorizes them into one of four categories based on their responses: \>75-no symptoms, 75 to \<175-mild IBS, 175 to \<300-moderate IBS, and ≥300-severe IBS.23

次要结局

  • Low FODMAP dietary adherence (LFDA)(Change from Baseline at week 6)
  • Low FODMAP dietary knowledge (LFDK)(Change from Baseline at week 6)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carol Johnston

Professor and Associate Dean

Arizona State University

研究点 (1)

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