Validation of a Food Frequency Questionnaire: VioScreen

March 6, 2023 updated by: University of Colorado, Denver
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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Denver, Colorado, United States, 80204
        • Denver Health
        • Contact:
        • Principal Investigator:
          • Stefka Fabbri, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

pregnant women and women of child-bearing age

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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."
6 weeks
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.
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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."
6 weeks
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."
6 weeks
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.
one month
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.
one month
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 weeks
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."
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Carina Venter, PhD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Estimate)

March 10, 2023

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 22-0904

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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