Effects of a Novel Machine Learning Mobile App on Diet Adherence in Individuals Following the Low Fodmap Diet
1 other identifier
interventional
58
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 23, 2020
CompletedFirst Submitted
Initial submission to the registry
February 1, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJuly 8, 2020
July 1, 2020
4 months
February 1, 2020
July 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rome IV
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. \[e.g., IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), IBS mixed typed (IBS-M), or IBS unsubtyped (IBS-U)\]
Change from Baseline at week 6
IBS-SSS
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
Change from Baseline at week 6
Secondary Outcomes (2)
Low FODMAP dietary adherence (LFDA)
Change from Baseline at week 6
Low FODMAP dietary knowledge (LFDK)
Change from Baseline at week 6
Study Arms (3)
Machine Learning App + Registered Dietitian facilitator
EXPERIMENTALThe 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
Machine Learning App
ACTIVE COMPARATORThe 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
Standard Dietary Education
PLACEBO COMPARATORGroup 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
Interventions
The Heali mobile application is a dietary resource validated by RD's which uses AI and ML to scan menus and barcodes to provide individuals with information regarding nutritive content and applicability to one's diet using an overall food score and traffic light system. Users have the ability to choose a number of therapeutic diets including LFD, SCD, GERD, and Lectin Free to name a few, but for this study, the app will be isolated to only the LFD. RDs employed by Heali provide real-time messaging to users. For this study, participants will be given access via cell phone login and password (names will not be used). Participant usage information will be de-identified and automatically sent to excel for study authors to perform statistical analysis.
The Heali mobile application is a dietary resource validated by RD's which uses AI and ML to scan menus and barcodes to provide individuals with information regarding nutritive content and applicability to one's diet using an overall food score and traffic light system. Users have the ability to choose a number of therapeutic diets including LFD, SCD, GERD, and Lectin Free to name a few, but for this study, the app will be isolated to only the LFD. For this study, participants will be given access via cell phone login and password (names will not be used). Participant usage information will be de-identified and automatically sent to excel for study authors to perform statistical analysis.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- individuals with food allergies (not food intolerances)
- smokers
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Arizona State University
Phoenix, Arizona, 85004, United States
Related Publications (1)
Rafferty AJ, Hall R, Johnston CS. A Novel Mobile App (Heali) for Disease Treatment in Participants With Irritable Bowel Syndrome: Randomized Controlled Pilot Trial. J Med Internet Res. 2021 Mar 2;23(3):e24134. doi: 10.2196/24134.
PMID: 33650977DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Associate Dean
Study Record Dates
First Submitted
February 1, 2020
First Posted
February 5, 2020
Study Start
January 23, 2020
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
July 8, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share