Gastrointestinal IrritationNCT03052452
My Nutritional Health App Testing
An observational study of Gastrointestinal Irritation, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The proposed My Nutritional Health (MNH) app is a unique tool for consumers interested in tracking their food intake and linking diet to symptoms. The investigators will test this app for developmental purposes among a sample of 100 participants who are patients of dietitians at Cedars-Sinai Medical Center (CSMC) and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Irritation
- What is being tested?
- My Nutritional Health App
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2017to 1 Oct 2020
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be identified from those who have made new patient appointments with participating dietitians at CSMC and University of Michigan. Patients will be recruited by email by their dietitian approximately two weeks before their scheduled appointment. If interested, they will be asked to download the LifeData app on their mobile devices and search for the My Nutritional Health app within LifeData. Once in the MNH app, participants will check for eligibility, review and complete consent forms, and answer general demographic and clinical questions. Since this study is app-based, participants must have modern smartphones with internet or data access to be eligible to participate.
Who may be able to join
- Greater than or equal to 18 years of age
- New patient visit with a participating dietitian at Cedars-Sinai Medical Center or University of Michigan
- Access to modern smartphone with internet or data access, to download and use the MNH app
Who cannot join
- Pregnancy, or plan to become pregnant during study.
- Inability to understand the English language
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
The proposed My Nutritional Health (MNH) app is a unique tool for consumers interested in tracking their food intake and linking diet to symptoms.
The investigators will test this app for developmental purposes among a sample of 100 participants who are patients of dietitians at Cedars-Sinai Medical Center (CSMC) and the University of Michigan (UM) with varying presentation of GI symptoms and suspected food intolerances. The MNH app built on the LifeData app will be used as a data collection platform for this study and can be utilized by iOS and Android smartphone devices. The investigators will use the data collected in the app testing to develop population-level FAST scores.
Read more
The MNH app includes two integrated functions:
- Patient Symptom and Food Consumption Reporting
- FAST Score calculation It is important to note that, per this protocol, the MNH app will only be evaluated for developmental purposes. It is currently not meant to serve as a diagnostic tool, nor to provide referrals for patients with food and symptom patterns that may suggest a food intolerance. In this respect, our test app is not governed by FDA or other regulatory bodies, as it does not make diagnoses or offer specific guidance. The purpose of this study is only to develop normative scoring distributions of FAST within the context of patients visiting GI dietitians as part of routine care.
Read the detailed description
The study aims are:
AIM 1 - To validate the FAST Instrument against existing patient-reported outcome (PRO) measures.
AIM 2 - To assess sensitivity of the FAST instrument to changes in patient diet.
Investigators will collect information about food intake and related symptoms using the MNH app to validate the FAST instrument and assess its sensitivity to change in patient diet. For this study, 100 participants who are scheduled to see participating dietitians at either Cedars-Sinai Medical Center or the University of Michigan will be recruited.
Participants will be asked to report information regarding food intake and symptoms for two weeks (one week pre- and one week post-dietitian visit). The MNH app will prompt users to log food intake and any symptoms that you are experiencing at multiple time points throughout the day. Investigators will reach out to participants via telephone during the first week of enrollment to inquire about their progress using the app, assist in troubleshooting for technical difficulties, and answer any questions.
At the end of each week, participants will be asked to respond to a standardized questionnaire about GI symptoms (the 15-item Gastrointestinal Symptom Rating Scale; GSRS) and a questionnaire about general health status (the PROMIS 10 Global Health, a 10-item questionnaire developed by NIH) through the MNH mobile app.
- Conditions
- Gastrointestinal Irritation
- Being tested
- My Nutritional Health App
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Nutritional Health AppOther
The My Nutritional Health app built in LifeData will be used as the data collection platform for this study. We will use the data collected in the app testing to develop population-level FAST scores.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Food and Symptom Tracker (FAST) Score
This scale was developed by study investigators to measure gastrointestinal symptom burden at a moment in time. Raw scores range from 0 to 210 depending on the number and severity of symptoms participants report experiencing. Scores closer to 0 indicate minimal symptom burden, while scores with higher values indicate more severe symptom burden. We will be assessing change in average FAST score pre-intervention (week 1 food and symptom logs) and post-intervention (week 2 food and symptom logs).
Measured: Daily for 2 weeks
Change in Gastrointestinal Symptom Rating Scale (GSRS) Scores
The Gastrointestinal Symptom Rating Scale is a validated survey used to measure symptom burden. This scale ranges from 15 to 105. Higher GSRS scores indicate more severe symptom burden. Participants will complete this survey twice throughout the study: once right before their dietitian appointment and once seven days after their visit. We will assess change in pre-intervention GSRS scores and post-intervention GSRS scores.
Measured: Once per week for 2 weeks
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scores
The PROMIS Global Health Short Form is a 10-item validated questionnaire that measures an individual's overall health. During scoring, this questionnaire is broken down into two measures (physical health and mental health) and two additional questions that should be interpreted using raw values. The raw values for both the physical and mental health sub-scores range from 0 to 20, whereas the raw values for the two self-standing questions range from 0 to 5. To properly interpret scores, questionnaire responses are scored by the PROMIS Assessment Center Scoring Service to provide t-score distributions standardized to the United States general population. Lower PROMIS Global Health scores indicate poorer overall health, while higher values indicate better overall health. We will assess change in pre-intervention PROMIS scores right before the patient's appointment with a dietitian and post-intervention PROMIS scores seven days after the appointment.
Measured: Once per week for 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start23 May 2017
- Primary completion1 Oct 2019
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal IrritationStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Société des Produits Nestlé (SPN)
- Responsible party
- Principal investigator, Brennan Spiegel, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052452
- Sponsor's protocol ID
- Pro00045933
- Status last verified
- Jan 2021
- First submitted
- 5 Jan 2017
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Nutritional Health App Testing
- ClinicalTrials.gov ID
- NCT03052452
- Acronym / sponsor ID
- Pro00045933
- Conditions
- Gastrointestinal Irritation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- University of Michigan, Société des Produits Nestlé (SPN)
- Study start
- 23 May 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 14 Feb 2017 (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.
The proposed My Nutritional Health (MNH) app is a unique tool for consumers interested in tracking their food intake and linking diet to symptoms.
The investigators will test this app for developmental purposes among a sample of 100 participants who are patients of dietitians at Cedars-Sinai Medical Center (CSMC) and the University of Michigan (UM) with varying presentation of GI symptoms and suspected food intolerances. The MNH app built on the LifeData app will be used as a data collection platform for this study and can be utilized by iOS and Android smartphone devices. The investigators will use the data collected in the app testing to develop population-level FAST scores.
The MNH app includes two integrated functions:
- Patient Symptom and Food Consumption Reporting
- FAST Score calculation It is important to note that, per this protocol, the MNH app will only be evaluated for developmental purposes. It is currently not meant to serve as a diagnostic tool, nor to provide referrals for patients with food and symptom patterns that may suggest a food intolerance. In this respect, our test app is not governed by FDA or other regulatory bodies, as it does not make diagnoses or offer specific guidance. The purpose of this study is only to develop normative scoring distributions of FAST within the context of patients visiting GI dietitians as part of routine care.
Detailed description
The study aims are:
AIM 1 - To validate the FAST Instrument against existing patient-reported outcome (PRO) measures.
AIM 2 - To assess sensitivity of the FAST instrument to changes in patient diet.
Investigators will collect information about food intake and related symptoms using the MNH app to validate the FAST instrument and assess its sensitivity to change in patient diet. For this study, 100 participants who are scheduled to see participating dietitians at either Cedars-Sinai Medical Center or the University of Michigan will be recruited.
Participants will be asked to report information regarding food intake and symptoms for two weeks (one week pre- and one week post-dietitian visit). The MNH app will prompt users to log food intake and any symptoms that you are experiencing at multiple time points throughout the day. Investigators will reach out to participants via telephone during the first week of enrollment to inquire about their progress using the app, assist in troubleshooting for technical difficulties, and answer any questions.
At the end of each week, participants will be asked to respond to a standardized questionnaire about GI symptoms (the 15-item Gastrointestinal Symptom Rating Scale; GSRS) and a questionnaire about general health status (the PROMIS 10 Global Health, a 10-item questionnaire developed by NIH) through the MNH mobile app.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be identified from those who have made new patient appointments with participating dietitians at CSMC and University of Michigan. Patients will be recruited by email by their dietitian approximately two weeks before their scheduled appointment. If interested, they will be asked to download the LifeData app on their mobile devices and search for the My Nutritional Health app within LifeData. Once in the MNH app, participants will check for eligibility, review and complete consent forms, and answer general demographic and clinical questions. Since this study is app-based, participants must have modern smartphones with internet or data access to be eligible to participate.
Key inclusion criteria (3 listed)
- Greater than or equal to 18 years of age
- New patient visit with a participating dietitian at Cedars-Sinai Medical Center or University of Michigan
- Access to modern smartphone with internet or data access, to download and use the MNH app
Key exclusion criteria (2 listed)
- Pregnancy, or plan to become pregnant during study.
- Inability to understand the English language
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 |
|---|---|---|
| My Nutritional Health AppThe My Nutritional Health app built in LifeData will be used as the data collection platform for this study. We will use the data collected in the app testing to develop population-level FAST scores. | Other | – |
Primary outcome
Change in Food and Symptom Tracker (FAST) Score
Time frame: Daily for 2 weeks
This scale was developed by study investigators to measure gastrointestinal symptom burden at a moment in time. Raw scores range from 0 to 210 depending on the number and severity of symptoms participants report experiencing. Scores closer to 0 indicate minimal symptom burden, while scores with higher values indicate more severe symptom burden. We will be assessing change in average FAST score pre-intervention (week 1 food and symptom logs) and post-intervention (week 2 food and symptom logs).
Change in Gastrointestinal Symptom Rating Scale (GSRS) Scores
Time frame: Once per week for 2 weeks
The Gastrointestinal Symptom Rating Scale is a validated survey used to measure symptom burden. This scale ranges from 15 to 105. Higher GSRS scores indicate more severe symptom burden. Participants will complete this survey twice throughout the study: once right before their dietitian appointment and once seven days after their visit. We will assess change in pre-intervention GSRS scores and post-intervention GSRS scores.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scores
Time frame: Once per week for 2 weeks
The PROMIS Global Health Short Form is a 10-item validated questionnaire that measures an individual's overall health. During scoring, this questionnaire is broken down into two measures (physical health and mental health) and two additional questions that should be interpreted using raw values. The raw values for both the physical and mental health sub-scores range from 0 to 20, whereas the raw values for the two self-standing questions range from 0 to 5. To properly interpret scores, questionnaire responses are scored by the PROMIS Assessment Center Scoring Service to provide t-score distributions standardized to the United States general population. Lower PROMIS Global Health scores indicate poorer overall health, while higher values indicate better overall health. We will assess change in pre-intervention PROMIS scores right before the patient's appointment with a dietitian and post-intervention PROMIS scores seven days after the appointment.
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 27 Jan 2021.
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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?
An observational study of Gastrointestinal Irritation, run by Cedars-Sinai Medical Center 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 3 inclusion and 2 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 27 Jan 2021. 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. 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?
Change in Food and Symptom Tracker (FAST) Score (time frame: Daily for 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2021.