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My Nutritional Health App Testing

NCT03052452 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 152

Last updated 2021-01-27

No results posted yet for this 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.

Conditions

  • Gastrointestinal Irritation

Interventions

OTHER

My Nutritional Health App

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.

Sponsors & Collaborators

  • University of Michigan

    collaborator OTHER

  • Société des Produits Nestlé (SPN)

    collaborator INDUSTRY

  • Cedars-Sinai Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-23
Primary Completion
2019-10-01
Completion
2020-10-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03052452 on ClinicalTrials.gov