HealthyNCT05228171
Mobile Food Record on Recall Effects
An observational study of Healthy, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- mCC app
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults
Who may be able to join
- 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
Who cannot join
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: 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).
- Conditions
- Healthy
- Being tested
- mCC app
- Keywords
- Mobile food record, nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mCC appBehavioural
Interviewer use of the mCC app during the 24-hour dietary recall interview.
| Study group | Role | What they receive |
|---|---|---|
| Standard Recall | Standard interviewer-administered 24-hour dietary recall. | |
| Augmented Recall | Interviewer use of the mCC app for 24-hour dietary recall. Receives: Behavioral: mCC app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caloric intake
Compare caloric intake assessed by the augmented recall relative to the standardized recall
Measured: 60 days from intervention
Secondary outcomes (1)
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)
Measured: 24 hours following food intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start14 Mar 2022
- Primary completion12 Jul 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Chow, MD, Principal investigator, UMN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228171
- Sponsor's protocol ID
- MED-2021-30429
- Status last verified
- Feb 2024
- First submitted
- 21 Jan 2022
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Mobile Food Record, Enhanced by a Novel Artificial Intelligence-Based Informatics Framework to Expand Capture of Dietary Intake
- ClinicalTrials.gov ID
- NCT05228171
- Acronym / sponsor ID
- MED-2021-30429
- Conditions
- Healthy
- Keywords
- Mobile food record, nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Recall | – | –Standard interviewer-administered 24-hour dietary recall. |
| Augmented Recall | – | Behavioral: mCC appInterviewer use of the mCC app for 24-hour dietary recall. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mCC appInterviewer use of the mCC app during the 24-hour dietary recall interview. | Behavioural | Augmented Recall |
Primary outcome
Caloric intake
Time frame: 60 days from intervention
Compare caloric intake assessed by the augmented recall relative to the standardized recall
1 secondary outcome
Energy intake
Time frame: 24 hours following food intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Chow, MD principal investigator
UMN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caloric intake (time frame: 60 days from intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.