NCT05228171

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 14, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 2, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

January 21, 2022

Last Update Submit

February 1, 2024

Conditions

Keywords

Mobile food recordnutrition

Outcome Measures

Primary Outcomes (1)

  • Caloric intake

    Compare caloric intake assessed by the augmented recall relative to the standardized recall

    60 days from intervention

Secondary Outcomes (1)

  • Energy intake

    24 hours following food intake

Study Arms (2)

Standard Recall

Standard interviewer-administered 24-hour dietary recall.

Augmented Recall

Interviewer use of the mCC app for 24-hour dietary recall.

Behavioral: mCC app

Interventions

mCC appBEHAVIORAL

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

Augmented Recall

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy adults

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

  • Lisa Chow, MD

    UMN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2022

First Posted

February 8, 2022

Study Start

March 14, 2022

Primary Completion

July 12, 2022

Study Completion

December 31, 2023

Last Updated

February 2, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations