My Nutritional Health App Testing
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/7/2018 |
| Start Date: | May 23, 2017 |
| End Date: | December 1, 2019 |
| Contact: | Alma Jusufagic, MPH |
| Email: | alma.jusufagic@cshs.org |
| Phone: | 310-423-6721 |
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:
1. Patient Symptom and Food Consumption Reporting
2. 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.
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:
1. Patient Symptom and Food Consumption Reporting
2. 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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnancy, or plan to become pregnant during study.
- Inability to understand the English language
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Phone: 310-423-6721
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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