IBS - Irritable Bowel SyndromeNCT04256551
Effects of a Novel Machine Learning Mobile App on Diet Adherence in Individuals Following the Low Fodmap Diet
A study testing Heali mobile application + Registered Dietitian, Heali mobile application and Standard Dietary Education in people with IBS - Irritable Bowel Syndrome, run by Arizona State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Heali mobile application + Registered Dietitian, Heali mobile application and Standard Dietary Education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2020to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Novel Machine Learning Mobile App on Diet Adherence in Individuals Following the Low Fodmap Diet: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Heali mobile application + Registered Dietitian, Heali mobile application, Standard Dietary Education
- Keywords
- high fermented, oligio-, di-, monosaccharide, and polyols, mobile app, irritable bowel syndrome
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heali mobile application + Registered DietitianOther
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.
Heali mobile applicationOther
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.
Standard Dietary EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Heali mobile application + Registered Dietitian; Other: Heali mobile application; Other: Standard Dietary Education |
| 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 Receives: Other: Heali mobile application; Other: Standard Dietary Education |
| 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 Receives: Other: Standard Dietary Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)]
Measured: 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
Measured: Change from Baseline at week 6
Secondary outcomes (2)
Low FODMAP dietary adherence (LFDA)
short Food Frequency Questionnaire (FFQ)
Measured: Change from Baseline at week 6
Low FODMAP dietary knowledge (LFDK)
short survey composed of a series of questions to determine participants' knowledge of the LFD
Measured: Change from Baseline at week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start23 Jan 2020
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carol Johnston, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256551
- Sponsor's protocol ID
- FODMAP/APP
- Status last verified
- Jul 2020
- First submitted
- 1 Feb 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33650977
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Novel Machine Learning Mobile App on Diet Adherence in Individuals Following the Low Fodmap Diet: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04256551
- Acronym / sponsor ID
- FODMAP/APP
- Conditions
- IBS - Irritable Bowel Syndrome
- Keywords
- high fermented, oligio-, di-, monosaccharide, and polyols, mobile app, irritable bowel syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Machine Learning App + Registered Dietitian facilitator | Experimental | Other: Heali mobile application + Registered Dietitian, Other: Heali mobile application, Other: Standard Dietary EducationThe 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 comparator | Other: Heali mobile application, Other: Standard Dietary EducationThe 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 comparator | Other: Standard Dietary EducationGroup 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heali mobile application + Registered DietitianThe 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. | Other | Machine Learning App + Registered Dietitian facilitator |
| Heali mobile applicationThe 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. | Other | Machine Learning App, Machine Learning App + Registered Dietitian facilitator |
| Standard Dietary EducationAn 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. | Other | Machine Learning App, Machine Learning App + Registered Dietitian facilitator, Standard Dietary Education |
Primary outcome
Rome IV
Time frame: 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
Time frame: 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
2 secondary outcomes
Low FODMAP dietary adherence (LFDA)
Time frame: Change from Baseline at week 6
Low FODMAP dietary knowledge (LFDK)
Time frame: Change from Baseline at week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Derived from this study: PubMed 33650977Rafferty 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heali mobile application + Registered Dietitian, Heali mobile application and Standard Dietary Education in people with IBS - Irritable Bowel Syndrome, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rome IV (time frame: Change from Baseline at week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04256551, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020; AzTrials last refreshed its copy on 6 Nov 2026.