Clinical trial NCT03218618: CHOKing Prevention Project
Official title: CHOKing Prevention Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Knowledge
Attitudes
Practice
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 1670
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Families

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.

Eligibility criteria: Inclusion Criteria:

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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.

Primary outcomes:
measure: percentage of correct answers to telephonic structured interview
timeFrame: up to 30 days after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: University of Padova
state: PD
Study officials:
References:
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.