Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-02-25 @ 9:39 PM
Study NCT ID:
NCT03218618
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2017-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CHOKing Prevention Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1670}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2017-06-01', 'studyFirstSubmitQcDate': '2017-07-12', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of correct answers to telephonic structured interview', 'timeFrame': 'up to 30 days after the intervention', 'description': 'percentage (%)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Knowledge', 'Attitudes', 'Practice']}, 'referencesModule': {'references': [{'pmid': '31438901', 'type': 'DERIVED', 'citation': 'Lorenzoni G, Azzolina D, Baldas S, Messi G, Lanera C, French MA, Da Dalt L, Gregori D. Increasing awareness of food-choking and nutrition in children through education of caregivers: the CHOP community intervention trial study protocol. BMC Public Health. 2019 Aug 22;19(1):1156. doi: 10.1186/s12889-019-7469-7.'}]}, 'descriptionModule': {'briefSummary': 'The aim of such study is to compare three different school-based (in nurseries, kindergartens and primary schools) interventions aimed at teaching to families how to prevent food choking injuries.\n\nThe topic of food choking primary and secondary prevention is placed in a more general topic regarding food safety, including education on food labeling and on food waste prevention.', 'detailedDescription': "The CHOP has been designed as a community intervention trial that compares three different school-based intervention strategies aimed at teaching to families how to prevent food choking injuries in children, together with the basics of food safety. The choice of employing such study design is motivated by the facts that community intervention trials allow to reach as many people as possible regardless their risk of experiencing the outcome of interest and to inform policy-makers on the effectiveness of an intervention on a community basis instead of an individual basis.\n\nForty-eight educational facilities (nurseries, kindergartens and primary schools) equally distributed between North, Centre, South, and major Islands of Italy will be enrolled.\n\nEducational facilities will be stratified so that each stratum will include one educational facility from each educational stage (stratum=1 nursery, 1 kindergarten, 1 primary school).\n\nThe assessment of the effectiveness of each intervention strategy will be performed through a structured telephonic interview one month after the delivery of the intervention. I\n\nSchools, to be enrolled, must provide:\n\n* availability of at least 45 families (one member from each family will be involved in the study);\n* availability of a room and of technological system (monitor, sound system) allowing the performance of the educational intervention;\n* availability of administrative support;\n* approval of the inclusion in the study by school's competent bodies.\n\nFamily members (one from each family) must be:\n\n* aged \\>18 years;\n* parent of children attending the school or person exercising the parental authority on children attending the school;\n* without physical impairments not allowing the performance of practical activities;\n* willing to participate at all stages of the study;\n* signed informed consent."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Families', 'eligibilityCriteria': "Inclusion Criteria:\n\n\\-\n\nSchools, to be enrolled, must provide:\n\n* availability of at least 45 families (one member from each family will be involved in the study);\n* availability of a room and of technological system (monitor, sound system) allowing the performance of the educational intervention;\n* availability of administrative support;\n* approval of the inclusion in the study by school's competent bodies.\n\nFamily members (one from each family) must be:\n\n* aged \\>18 years;\n* parent of children attending the school or person exercising the parental authority on children attending the school;\n* without physical impairments not allowing the performance of practical activities;\n* willing to participate at all stages of the study;\n* signed informed consent.\n\nExclusion Criteria:\n\n* Schools that will not meet inclusion criteria will not be enrolled in the study.\n\nFamily members who will not meet the inclusion criteria will not be involved in the study."}, 'identificationModule': {'nctId': 'NCT03218618', 'acronym': 'CHOP', 'briefTitle': 'CHOKing Prevention Project', 'organization': {'class': 'OTHER', 'fullName': 'University of Padova'}, 'officialTitle': 'CHOKing Prevention Project', 'orgStudyIdInfo': {'id': 'CHOP2017'}}, 'contactsLocationsModule': {'locations': [{'zip': '35142', 'city': 'Padua', 'state': 'PD', 'country': 'Italy', 'facility': 'University of Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Padova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}