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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05228171
Other study ID # MED-2021-30429
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 14, 2022
Est. completion date December 31, 2023

Study information

Verified date February 2024
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 31, 2023
Est. primary completion date July 12, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
mCC app
Interviewer use of the mCC app during the 24-hour dietary recall interview.

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Caloric intake Compare caloric intake assessed by the augmented recall relative to the standardized recall 60 days from intervention
Secondary Energy 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
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