- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05228171
Mobile Food Record on Recall Effects
Use of a Mobile Food Record, Enhanced by a Novel Artificial Intelligence-Based Informatics Framework to Expand Capture of Dietary Intake
Human dietary habits remain challenging to measure. Even the "gold-standard" interviewer-administered 24 hour dietary recall has established underreporting issues especially in high-risk populations, such as patients with obesity. Performance of precision nutrition research requires state of the art tools to capture individual dietary patterns. Given the widespread availability of smart phones, mobile-phone based food records present a prime opportunity to capture "in the field" dietary intake. Mobile food records, however, are not yet widely used in nutrition research. Several reasons exist. First, the mobile food record needs to be validated relative to the "gold standard" of dietary intake, the 24-hour dietary recall. Second, many available mobile food records are commercially based, with caveats about data availability and meeting research-quality data security practices (HIPAA compliance).
In response, this study includes using a freely available, research-focused, HIPAA compliant, mobile food record (mCC: my Circadian Clock app) actively used in research studies (including our own ongoing work) to test the hypothesis that a mobile food record can expand capture of dietary intake. The proposed aims include the following: Using a randomized, cross-over design, evaluation of augmenting interviewer-administered 24-hour dietary recalls by a mobile food record (Augmented Recall) results in less energy intake underreporting than a standard (un-augmented) interviewer administered 24-hour dietary recall (Standard Recall).
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults between 18-65 years old
- BMI ≥30 kg/m2
- Without a 4 year (BS/BA) college degree
- Owns a smart phone
- Able to read and speak English
Exclusion Criteria:
• Pregnant or lactating women
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Standard Recall
Standard interviewer-administered 24-hour dietary recall.
|
|
Augmented Recall
Interviewer use of the mCC app for 24-hour dietary recall.
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Interviewer use of the mCC app during the 24-hour dietary recall interview.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caloric intake
Time Frame: 60 days from intervention
|
Compare caloric intake assessed by the augmented recall relative to the standardized recall
|
60 days from intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy intake
Time Frame: 24 hours following food intake
|
Comparison of the energy intake calculated from the 24 hour interviewer administered dietary recall which is augmented by concurrent use and review of a mobile food record (Augmented Recall) vs the energy intake calculated from standard interviewer administered 24-hour dietary recall (Standard Recall)
|
24 hours following food intake
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lisa Chow, MD, UMN
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MED-2021-30429
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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