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NCT03052452 · ClinicalTrials.gov registry record
My Nutritional Health App Testing
A clinical trial, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- 152
- Enrollment target
NCT03052452: Completed study, sponsored by Cedars-Sinai Medical Center.
NCT03052452 is a clinical trial that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 152 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03052452 has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- 152 participants
- Enrollment target
Study 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 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.
Primary Outcome
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).
Interventions
- OTHER My Nutritional Health App
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2017-05-23 |
| Est. Completion | 2020-10-01 |
What the finished NCT03052452 record still lists
NCT03052452 is an observational study that tracks outcomes without assigning an intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which My Nutritional Health App is the first listed.
NCT03052452 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03052452 about?
NCT03052452 is a clinical study titled "My Nutritional Health App Testing". 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 Medica...
What is the current status of trial NCT03052452?
This trial is currently completed. The enrollment target is 152 participants. The study started on 2017-05-23. Estimated completion is 2020-10-01.
What interventions are being tested in trial NCT03052452?
The interventions under investigation include: My Nutritional Health App (OTHER).
Who is sponsoring clinical trial NCT03052452?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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