Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03218618 |
Other study ID # |
CHOP2017 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 1, 2017 |
Est. completion date |
March 31, 2019 |
Study information
Verified date |
April 2021 |
Source |
University of Padova |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.