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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.


Recruitment information / eligibility

Status Completed
Enrollment 1670
Est. completion date March 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Italy University of Padova Padova PD

Sponsors (1)

Lead Sponsor Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary percentage of correct answers to telephonic structured interview percentage (%) up to 30 days after the intervention
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