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OpenTrials
Completed

NCT Number: NCT05762718

Validation of a Food Frequency Questionnaire: VioScreen

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.

Completed

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Key information

Conditions

Not Determined

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Children's Hospital Colorado, Aurora, Colorado, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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."

  2. 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.

Secondary outcomes

  1. Concurrent validity of VioScreen against Veggie Meter

    Time frame: 6 weeks

    Concurrent validity measures how a new test compares against a validated test, called the criterion or "gold standard."

  2. Concurrent validity of VioScreen against Fruit and Vegetable Screener

    Time frame: 6 weeks

    Concurrent validity measures how a new test compares against a validated test, called the criterion or "gold standard."

  3. Test-retest reliability of Veggie Meter

    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.

  4. Test-retest reliability of Fruit and Vegetable Screener

    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.

  5. Concurrent validity of Veggie Meter 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."

  6. Concurrent validity of Fruit and Vegetable Screener 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."

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 10, 2023
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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