Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT05762718
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2023-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of a Food Frequency Questionnaire: VioScreen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-27', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concurrent validity of VioScreen against 24-hour recalls', 'timeFrame': '6 weeks', 'description': 'Concurrent validity measures how a new test compares against a validated test, called the criterion or "gold standard."'}, {'measure': 'Test-retest reliability of VioScreen', 'timeFrame': 'one month', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Concurrent validity of VioScreen against Veggie Meter', 'timeFrame': '6 weeks', 'description': 'Concurrent validity measures how a new test compares against a validated test, called the criterion or "gold standard."'}, {'measure': 'Concurrent validity of VioScreen against Fruit and Vegetable Screener', 'timeFrame': '6 weeks', 'description': 'Concurrent validity measures how a new test compares against a validated test, called the criterion or "gold standard."'}, {'measure': 'Test-retest reliability of Veggie Meter', 'timeFrame': 'one month', 'description': '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.'}, {'measure': 'Test-retest reliability of Fruit and Vegetable Screener', 'timeFrame': 'one month', 'description': '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.'}, {'measure': 'Concurrent validity of Veggie Meter against 24-hour recalls', 'timeFrame': '6 weeks', 'description': 'Concurrent validity measures how a new test compares against a validated test, called the criterion or "gold standard."'}, {'measure': 'Concurrent validity of Fruit and Vegetable Screener against 24-hour recalls', 'timeFrame': '6 weeks', 'description': 'Concurrent validity measures how a new test compares against a validated test, called the criterion or "gold standard."'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Not Determined']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women and women of child-bearing age', 'genderDescription': 'Women of child-bearing age', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-40 as we are aiming to recruit women of child-bearing age\n* Pregnant women up to 26 weeks' gestation\n* Women assigned female sex at birth who are not pregnant\n\nExclusion Criteria:\n\n* Women below the age of 18 or over the age of 40 years\n* Pregnant women more than 26 weeks' gestation at the time of enrollment\n* Women who are experiencing limited or reduced food intake related to nausea will not be approached for recruitment and are considered ineligible\n* Women who are unwilling to participate in the study due to time commitment or other reasons\n* 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"}, 'identificationModule': {'nctId': 'NCT05762718', 'briefTitle': 'Validation of a Food Frequency Questionnaire: VioScreen', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Validation of a Food Frequency Questionnaire: VioScreen', 'orgStudyIdInfo': {'id': '22-0904'}}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Carina Venter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}