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Clinical Trials/NCT03218618
NCT03218618
Completed
Not Applicable

CHOKing Prevention Project

University of Padova1 site in 1 country1,670 target enrollmentDecember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Health Knowledge
Sponsor
University of Padova
Enrollment
1670
Locations
1
Primary Endpoint
percentage of correct answers to telephonic structured interview
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

The 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.

Detailed Description

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. Forty-eight educational facilities (nurseries, kindergartens and primary schools) equally distributed between North, Centre, South, and major Islands of Italy will be enrolled. Educational 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). The 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 Schools, to be enrolled, must provide: * availability of at least 45 families (one member from each family will be involved in the study); * availability of a room and of technological system (monitor, sound system) allowing the performance of the educational intervention; * availability of administrative support; * approval of the inclusion in the study by school's competent bodies. Family members (one from each family) must be: * aged \>18 years; * parent of children attending the school or person exercising the parental authority on children attending the school; * without physical impairments not allowing the performance of practical activities; * willing to participate at all stages of the study; * signed informed consent.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
March 31, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Padova
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Schools, to be enrolled, must provide:
  • availability of at least 45 families (one member from each family will be involved in the study);
  • availability of a room and of technological system (monitor, sound system) allowing the performance of the educational intervention;
  • availability of administrative support;
  • approval of the inclusion in the study by school's competent bodies.
  • Family members (one from each family) must be:
  • aged \>18 years;
  • parent of children attending the school or person exercising the parental authority on children attending the school;
  • without physical impairments not allowing the performance of practical activities;
  • willing to participate at all stages of the study;

Exclusion Criteria

  • Schools that will not meet inclusion criteria will not be enrolled in the study.
  • Family members who will not meet the inclusion criteria will not be involved in the study.

Outcomes

Primary Outcomes

percentage of correct answers to telephonic structured interview

Time Frame: up to 30 days after the intervention

percentage (%)

Study Sites (1)

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