Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2026-03-03 @ 2:35 AM
Study NCT ID:
NCT03318328
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2017-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Food Insecurity in Adults and Children With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2015-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2017-10-16', 'studyFirstSubmitQcDate': '2017-10-18', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate food insecurity incidence in CF patients', 'timeFrame': 'one time questionnaire administered during a clinic visit', 'description': 'Using a survey, determine the number of people who report food insecurity'}], 'secondaryOutcomes': [{'measure': 'Determine if food insecurity leads to worse lung function in CF patients', 'timeFrame': 'one time questionnaire administered during a clinic visit', 'description': 'Using a survey, report the current FEV1 and the number of people who report food insecurity to determine if there is a correlation'}, {'measure': 'Determine if food insecurity leads to worse BMI in CF patients', 'timeFrame': 'one time questionnaire administered during a clinic visit.', 'description': 'using a survey, report the current BMI and the number of people who report food insecurity to see if there is a correlation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.frontiersin.org/articles/10.3389/fpubh.2018.00348/full', 'label': 'Publication'}]}, 'descriptionModule': {'briefSummary': 'A survey of adults and parents of children with cystic fibrosis on food insecurity', 'detailedDescription': 'A survey of adults and parents of children with cystic fibrosis to determine any correlation between food insecurity and BMI or food insecurity and FEV1, and to determine what level of food insecurity is present.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adults and parents of children with cystic fibrosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: have CF and are willing to complete a questionnaire during a routine clinic visit\n\n\\-\n\nExclusion Criteria:\n\n* NA'}, 'identificationModule': {'nctId': 'NCT03318328', 'acronym': 'FI', 'briefTitle': 'Evaluation of Food Insecurity in Adults and Children With Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': "St. Luke's Health System, Boise, Idaho"}, 'officialTitle': 'Evaluation of Food Insecurity in Adults and Children With Cystic Fibrosis', 'orgStudyIdInfo': {'id': '2017Food'}}, 'armsInterventionsModule': {'interventions': [{'name': 'survey', 'type': 'OTHER'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dixie Durham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Coordinator', 'investigatorFullName': 'Dixie Durham', 'investigatorAffiliation': "St. Luke's Health System, Boise, Idaho"}}}}