An Integrated Intervention to Reduce Secondhandsmoke in Children (RESPIR·NET)

June 18, 2013 updated by: Institut Català d'Oncologia

Respiratory Symptoms, Asthma and Passive Smoking in Children: Effectiveness of an Integrated Individual, Family, and School-based Intervention

This is a community essay to assess the effectiveness of a multi-level (individual, family, and school) school-based intervention to prevent the exposure to secondhand smoke (SHS) in a population of 1,734 schoolchildren (12-14 years old) in Terrassa (Catalonia, Spain). Schools were assigned to the intervention or the controlgroup at random. The investigators assessed SHS exposure in different settings (at school, at home, on transportation and leisure time) and tobacco consumption by means of a questionnaire before and one year after the intervention. Based on a previously evaluated intervention to prevent smoking initiation (PASE/ESFA program) the investigators designed a new intervention (the RESPIR•NET Program) including two new activities to prevent passive smoking to be applied at three levels: in the classroom (pupils), at the school (pupils, teachers, and parents), and in the family (pupils and parents).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1779

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Catalan Institute of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 14 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all schoolchildren attending the school at the day of interview

Exclusion Criteria:

  • absence of school
  • language problems with questionnaire

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Schoolchildren aged 12-13 years in the first year of Compulsory Secondary Education (Enseñanza Secundaria Obligatoria in the Spanish educational system) in the city of Terrassa. The CONTROL arm is formed by schoolchildren in schools that willnot receive the intervention and will continue with ongoing (usual) health education sessions.
Experimental: Intervention
The intervention at the classroom consisted of six sessions with the pupils of one hour each that were conducted by the teacher/tutor. We provided the teachers with a training session and a teachers' guide, and we gave each pupil a workbook with the activities. At the school level, the intervention consisted of four types of posters with specific messages directed to students, teachers, and parents, and the fourth poster type advertised the new smoking laws. we gave teachers and school managers the guide "Towards a Smoke-Free School" to facilitate the prevention and control of smoking (active and passive) in the school environment. Family level activities: Parents were required to complete the "My risk thermometer" activity at home with their children. Parents received a brochure with information on the risks of SHS exposure and recommendations to prevent SHS exposure, and a refrigerator magnet with the logo of the program.
Behavioral: RESPIRNET Program
The intervention at the classroom consisted of six sessions with the pupils of one hour each that were conducted by the teacher/tutor. We provided the teachers with a training session and a teachers' guide, and we gave each pupil a workbook with the activities. At the school level, the intervention consisted of four types of posters with specific messages directed to students, teachers, and parents, and the fourth poster type advertised the new smoking laws. we gave teachers and school managers the guide "Towards a Smoke-Free School" to facilitate the prevention and control of smoking (active and passive) in the school environment. Family level activities: Parents were required to complete the "My risk thermometer" activity at home with their children. Parents received a brochure with information on the risks of SHS exposure and recommendations to prevent SHS exposure, and a refrigerator magnet with the logo of the program.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence of exposure to secondhand smoke
Time Frame: 1 year
The prevalence of exposure to secondhand smoke is computed by dividing the number of children exposed / total number of children. Exposure to secondhand smoke is obtained using a questionnaire at baseline and one year later. The questionnaire was prepared from previously validated questionnaires on SHS.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prevalence of current smokers
Time Frame: 1 year
The prevalence of smoking is computed by dividing the number of smoking children / total number of children. Smoker status is obtained using a questionnaire at baseline and one year later. The questionnaire has been previously validated in other investigations.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Català d'Oncologia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Public Health Agency of Barcelona
Fundació La Marató de TV3
Institut Municipal d'Investigació Mèdica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 040830
  • 64/04 (Other Identifier: Bellvitge's CEIC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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