My Nutritional Health App Testing

Gastrointestinal Irritation Clinical Trial

Official title:

My Nutritional Health App Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03052452
• Other study ID #: Pro00045933
• Status: Completed
• Start date: May 23, 2017
• Est. completion date: October 1, 2020

Study information

• Verified date: January 2021
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Irritation

Intervention

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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	Nestlé, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Daily for 2 weeks
Primary	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.	Once per week for 2 weeks
Primary	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.	Once per week for 2 weeks