Validation of a Food Frequency Questionnaire: VioScreen

Completed

• Conditions: Not Determined

• Registration Number: NCT05762718
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-16
• Study First Submitted: 2023-02-22
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-10
• Primary Completion: 2024-04-16
• Study Completion: 2024-04-16
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concurrent validity of VioScreen against 24-hour recalls	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	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 Outcome Measures

Name	Time	Method
Concurrent validity of VioScreen against Veggie Meter	6 weeks	Concurrent validity measures how a new test compares against a validated test, called the criterion or "gold standard."
Concurrent validity of VioScreen against Fruit and Vegetable Screener	6 weeks	Concurrent validity measures how a new test compares against a validated test, called the criterion or "gold standard."
Test-retest reliability of Veggie Meter	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.
Test-retest reliability of Fruit and Vegetable Screener	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.
Concurrent validity of Veggie Meter against 24-hour recalls	6 weeks	Concurrent validity measures how a new test compares against a validated test, called the criterion or "gold standard."
Concurrent validity of Fruit and Vegetable Screener against 24-hour recalls	6 weeks	Concurrent validity measures how a new test compares against a validated test, called the criterion or "gold standard."

Trial Locations

Locations (2)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Denver Health; 🇺🇸 Denver, Colorado, United States