Health KnowledgeCHOPNCT03218618
CHOKing Prevention Project
An observational study of Health Knowledge and Attitudes, run by University of Padova at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Health Knowledge, Attitudes, Practice
- How many people
- 1,670 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2017to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
Study population: Families
Who may be able to join
- -
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Health Knowledge, Attitudes, Practice
- Medical subject headings
- Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of correct answers to telephonic structured interview
percentage (%)
Measured: up to 30 days after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start1 Dec 2017
- Primary completion31 Dec 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health KnowledgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,670 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218618
- Sponsor's protocol ID
- CHOP2017
- Acronym
- CHOP
- Status last verified
- Apr 2021
- First submitted
- 1 Jun 2017
- Last updated
- 28 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31438901
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHOKing Prevention Project
- ClinicalTrials.gov ID
- NCT03218618
- Acronym / sponsor ID
- CHOP / CHOP2017
- Conditions
- Health Knowledge, Attitudes, Practice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,670 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Families
Key inclusion criteria (12 listed)
- -
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
percentage of correct answers to telephonic structured interview
Time frame: up to 30 days after the intervention
percentage (%)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 31438901Lorenzoni 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.
Related trials for Health Knowledge
Not yet recruiting
Pilot Study to Co-create and Implement a Multicomponent Intervention to Reduce Mental Health Stigma in Primary Care
Mental Health, Stigma of Mental Illness
Active, not recruiting
A Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship
Childhood Cancer, Survivorship
Not yet recruiting
Health Care Professionals Diet App Study
Nutrition Education
Recruiting
Evaluating AI for the Translation of KM Resources
Communication Research
Not yet recruiting
Effectiveness of Directed Self Learning Versus Instructor-Led Teaching Using an Identical Standardized Instructional Module on Infection Prevention and Control Among Undergraduate Allied Health Sciences Students
Infection Prevention and Control Education, Health Professions Education
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Knowledge and Attitudes, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of correct answers to telephonic structured interview (time frame: up to 30 days after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03218618, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.