Not DeterminedNCT05762718
Validation of a Food Frequency Questionnaire: VioScreen
An observational study of Not Determined, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
The purpose of this study is to learn more about how well a questionnaire about food intake works. The study team will compare questionnaire responses to several other measurements of food intake. There is a special emphasis on fruit and vegetable intake. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Not Determined
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Dec 2022to 16 Apr 2024
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant women and women of child-bearing age
Who may be able to join
- Age 18-40 as we are aiming to recruit women of child-bearing age
- Pregnant women up to 26 weeks' gestation
- Women assigned female sex at birth who are not pregnant
Who cannot join
- Women below the age of 18 or over the age of 40 years
- Pregnant women more than 26 weeks' gestation at the time of enrollment
- Women who are experiencing limited or reduced food intake related to nausea will not be approached for recruitment and are considered ineligible
- Women who are unwilling to participate in the study due to time commitment or other reasons
- Women whose capacity for study compliance is diminished due to conditions such as active untreated substance use disorder, untreated/uncontrolled schizophrenia, bipolar disorder, active psychosis will not be approached for recruitment and are considered ineligible
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Denver Health
Denver, Colorado, 80204
About this study
The purpose of this study is to learn more about how well a questionnaire about food intake works. The study team will compare questionnaire responses to several other measurements of food intake. There is a special emphasis on fruit and vegetable intake.
- Conditions
- Not Determined
What is being measured
The primary outcome is the main question the study is designed to answer.
Concurrent validity of VioScreen against 24-hour recalls
Concurrent validity measures how a new test compares against a validated test, called the criterion or "gold standard."
Measured: 6 weeks
Test-retest reliability of VioScreen
Test-retest reliability is a measure of reliability obtained by administering the same test twice over a period of time to a group of individuals.
Measured: one month
Secondary outcomes (6)
Concurrent validity of VioScreen against Veggie Meter
Concurrent validity measures how a new test compares against a validated test, called the criterion or "gold standard."
Measured: 6 weeks
Concurrent validity of VioScreen against Fruit and Vegetable Screener
Concurrent validity measures how a new test compares against a validated test, called the criterion or "gold standard."
Measured: 6 weeks
Test-retest reliability of Veggie Meter
Test-retest reliability is a measure of reliability obtained by administering the same test twice over a period of time to a group of individuals.
Measured: one month
Test-retest reliability of Fruit and Vegetable Screener
Test-retest reliability is a measure of reliability obtained by administering the same test twice over a period of time to a group of individuals.
Measured: one month
Concurrent validity of Veggie Meter against 24-hour recalls
Concurrent validity measures how a new test compares against a validated test, called the criterion or "gold standard."
Measured: 6 weeks
Concurrent validity of Fruit and Vegetable Screener against 24-hour recalls
Concurrent validity measures how a new test compares against a validated test, called the criterion or "gold standard."
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start16 Dec 2022
- Primary completion16 Apr 2024
- Study completion16 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Not DeterminedStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carina Venter, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762718
- Sponsor's protocol ID
- 22-0904
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Food Frequency Questionnaire: VioScreen
- ClinicalTrials.gov ID
- NCT05762718
- Acronym / sponsor ID
- 22-0904
- Conditions
- Not Determined
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 10 Mar 2023 (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.
The purpose of this study is to learn more about how well a questionnaire about food intake works. The study team will compare questionnaire responses to several other measurements of food intake. There is a special emphasis on fruit and vegetable intake.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant women and women of child-bearing age
Key inclusion criteria (3 listed)
- Age 18-40 as we are aiming to recruit women of child-bearing age
- Pregnant women up to 26 weeks' gestation
- Women assigned female sex at birth who are not pregnant
Key exclusion criteria (5 listed)
- Women below the age of 18 or over the age of 40 years
- Pregnant women more than 26 weeks' gestation at the time of enrollment
- Women who are experiencing limited or reduced food intake related to nausea will not be approached for recruitment and are considered ineligible
- Women who are unwilling to participate in the study due to time commitment or other reasons
- Women whose capacity for study compliance is diminished due to conditions such as active untreated substance use disorder, untreated/uncontrolled schizophrenia, bipolar disorder, active psychosis will not be approached for recruitment and are considered ineligible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concurrent validity of VioScreen against 24-hour recalls
Time frame: 6 weeks
Concurrent validity measures how a new test compares against a validated test, called the criterion or "gold standard."
Test-retest reliability of VioScreen
Time frame: one month
Test-retest reliability is a measure of reliability obtained by administering the same test twice over a period of time to a group of individuals.
6 secondary outcomes
Concurrent validity of VioScreen against Veggie Meter
Time frame: 6 weeks
Concurrent validity of VioScreen against Fruit and Vegetable Screener
Time frame: 6 weeks
Test-retest reliability of Veggie Meter
Time frame: one month
Test-retest reliability of Fruit and Vegetable Screener
Time frame: one month
Concurrent validity of Veggie Meter against 24-hour recalls
Time frame: 6 weeks
Concurrent validity of Fruit and Vegetable Screener against 24-hour recalls
Time frame: 6 weeks
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 1 Oct 2024.
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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.
Carina Venter, PhD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Not Determined, run by University of Colorado, Denver at 2 sites 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 3 inclusion and 5 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 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Concurrent validity of VioScreen against 24-hour recalls (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 1 Oct 2024.