CHOKing Prevention Project

Completed

• Conditions: Health Knowledge; Practice; Attitudes

• Registration Number: NCT03218618
• Lead Sponsor: University of Padova

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.

Study Timeline

• Study First Submitted: 2017-06-01
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-14
• Study Start: 2017-12-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-03-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1670

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;
• signed informed consent.

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
percentage of correct answers to telephonic structured interview	up to 30 days after the intervention	percentage (%)

Trial Locations

Locations (1)

University of Padova; 🇮🇹 Padova, PD, Italy