Validation of a Food Frequency Questionnaire: VioScreen

NCT05762718 | Completed

• 1 other identifier: 22-0904
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Not Determined

Outcome Measures

Primary Outcomes (2)

• 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."

  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.

  one month

Secondary Outcomes (6)

• Concurrent validity of VioScreen against Veggie Meter

  6 weeks

• Concurrent validity of VioScreen against Fruit and Vegetable Screener

  6 weeks

• Test-retest reliability of Veggie Meter

  one month

• Test-retest reliability of Fruit and Vegetable Screener

  one month

• Concurrent validity of Veggie Meter against 24-hour recalls

  6 weeks

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Women of child-bearing age
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women and women of child-bearing age

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (2)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Denver Health

Denver, Colorado, 80204, United States

Location

Study Officials

• Carina Venter, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 10, 2023
• Study Start: December 16, 2022
• Primary Completion: April 16, 2024
• Study Completion: April 16, 2024
• Last Updated: October 1, 2024

Record last verified: 2023-03

Locations

US (2)