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临床试验/NCT03218618
NCT03218618已完成不适用

CHOKing Prevention Project

University of Padova1 个研究点 分布在 1 个国家目标入组 1,670 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,670
试验地点
1
主要终点
percentage of correct answers to telephonic structured interview

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

percentage of correct answers to telephonic structured interview

时间窗: up to 30 days after the intervention

percentage (%)

次要结局

未报告次要终点

研究者

发起方
University of Padova
申办方类型
Other
责任方
Sponsor

研究点 (1)

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