<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04437641</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/19/0359</org_study_id>
    <nct_id>NCT04437641</nct_id>
  </id_info>
  <brief_title>Impact of Pediatrician Intervention on the Smoking Habits of Parents of Sick Children</brief_title>
  <acronym>MUCODIABTAB</acronym>
  <official_title>Impact of Pediatrician Intervention on the Smoking Habits of Parents of Children With Cystic Fibrosis, Type 1 Diabetes or Children Hospitalized for a First Episode of Bronchiolitis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Reducing tobacco consumption is a major public health objective, with the prevalence of&#xD;
      active smoking estimated in 2017 at 26.9% of the French population aged 18 to 25. The&#xD;
      negative impact of passive smoking on children's health and development has been demonstrated&#xD;
      by numerous studies, especially with regard to respiratory pathologies. Parental smoking is&#xD;
      also a risk factor for active smoking in adolescence and adulthood (with an odds ratio of&#xD;
      1.72 if at least one of the two parents is a smoker). It has been shown that intervention&#xD;
      with parents can reduce the number of children exposed to passive parental smoking by about&#xD;
      5%.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reducing tobacco consumption is a major public health objective, with the prevalence of&#xD;
      active smoking estimated in 2017 at 26.9% of the French population aged 18 to 25. The&#xD;
      negative impact of passive smoking on children's health and development has been demonstrated&#xD;
      by numerous studies, especially with regard to respiratory pathologies. Parental smoking is&#xD;
      also a risk factor for active smoking in adolescence and adulthood (with an odds ratio of&#xD;
      1.72 if at least one of the two parents is a smoker). It has been shown that intervention&#xD;
      with parents can reduce the number of children exposed to passive parental smoking by about&#xD;
      5%. The paediatrician's role is therefore to try to make parents aware of the consequences of&#xD;
      tobacco consumption on their children's health and to encourage them to stop smoking. Minimal&#xD;
      advice (simple, clear, written and oral information on the actors and means of helping to&#xD;
      stop smoking) is the first step in triggering an attempt to stop smoking. The paediatrician&#xD;
      seems to be a particularly influential actor since he intervenes at a time when parents are&#xD;
      trying to improve their child's health. The minimum advice would have an effectiveness of&#xD;
      2-5% on smoking cessation in general. There is no data on the impact of this minimum advice&#xD;
      when given by paediatricians. There are also no data on the current prevalence of smoking in&#xD;
      France among parents of children with various chronic diseases, such as cystic fibrosis or&#xD;
      diabetes. It is also necessary to describe the smoking habits of parents, as children's&#xD;
      exposure and its impact on their health depends in particular on where their parents smoke.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 22, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Smoking prevalence</measure>
    <time_frame>18 months</time_frame>
    <description>establish the effect of minimal advice (oral + orientation leaflet) given by the paediatrician following children with cystic fibrosis, diabetes or hospitalized for a first episode of bronchiolitis on the parents' smoking habits.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parental smoking evolution</measure>
    <time_frame>18 months</time_frame>
    <description>Evolution of parental smoking habits 3 months after this advice by :&#xD;
Smoking statue number of cigarets/day</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Tobacco Consumption</condition>
  <condition>Bronchiolitis</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <description>A questionnaire on smoking habits was given to all parents of children being followed in consultation for cystic fibrosis or type 1 diabetes, or whose child was hospitalized for the first time for bronchiolitis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tobacco questionnaire</intervention_name>
    <description>A questionnaire on smoking habits was given to all parents of children being followed in consultation for cystic fibrosis or type 1 diabetes, or whose child was hospitalized for the first time for bronchiolitis.&#xD;
Provision of minimal advice (oral and a leaflet from the anti-smoking centre) to parents who smoke by the paediatrician following the child.&#xD;
For parents who smoke, evaluation at 3 months of the impact of this minimal advice by another questionnaire during the usual follow-up of the patient at 3 months or by telephone contact.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Recruitment of parents accompanying paediatric patients followed in consultation or seen in&#xD;
        hospital in the departments of pneumology and paediatric diabetology at Toulouse University&#xD;
        Hospital.&#xD;
&#xD;
        The doctor proposes to the parent to participate in this research and informs him/her:&#xD;
&#xD;
          -  of the objective,&#xD;
&#xD;
          -  of the computerised processing of the data concerning him/her that will be collected&#xD;
             in the course of this research and also specifies his/her rights of access, opposition&#xD;
             and rectification to this data.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents of legal age, of children being followed for cystic fibrosis or type 1&#xD;
             diabetes or being hospitalized for the first time for bronchiolitis.&#xD;
&#xD;
          -  Having given their non-opposition to participate in the research&#xD;
&#xD;
          -  Covered by a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate&#xD;
&#xD;
          -  Parent already in the process of quitting smoking&#xD;
&#xD;
          -  Adult person under guardianship/curators or safeguard of justice&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie MITTAINE</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marie MITTAINE, MD</last_name>
    <phone>5 34 55 87 37</phone>
    <phone_ext>+33</phone_ext>
    <email>mittaine.m@chu-toulouse.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Isabelle OLIVIER, PhD</last_name>
    <phone>05-61-77-70-51</phone>
    <phone_ext>+33</phone_ext>
    <email>olivier.i@chu-toulouse.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>MITTAINE</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie MITTAINE</last_name>
      <phone>5 34 55 87 37</phone>
      <phone_ext>+33</phone_ext>
    </contact>
    <contact_backup>
      <last_name>Amélie ARROUY</last_name>
      <phone>5 61 77 62 33</phone>
      <phone_ext>+33</phone_ext>
      <email>arrouy.a@chu-toulouse.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>March 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tobacco Consumption</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04437641
org study id: RC31/19/0359
nct id: NCT04437641
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Reducing tobacco consumption is a major public health objective, with the prevalence of
      active smoking estimated in 2017 at 26.9% of the French population aged 18 to 25. The
      negative impact of passive smoking on children's health and development has been demonstrated
      by numerous studies, especially with regard to respiratory pathologies. Parental smoking is
      also a risk factor for active smoking in adolescence and adulthood (with an odds ratio of
      1.72 if at least one of the two parents is a smoker). It has been shown that intervention
      with parents can reduce the number of children exposed to passive parental smoking by about
      5%.
Reducing tobacco consumption is a major public health objective, with the prevalence of
      active smoking estimated in 2017 at 26.9% of the French population aged 18 to 25. The
      negative impact of passive smoking on children's health and development has been demonstrated
      by numerous studies, especially with regard to respiratory pathologies. Parental smoking is
      also a risk factor for active smoking in adolescence and adulthood (with an odds ratio of
      1.72 if at least one of the two parents is a smoker). It has been shown that intervention
      with parents can reduce the number of children exposed to passive parental smoking by about
      5%. The paediatrician's role is therefore to try to make parents aware of the consequences of
      tobacco consumption on their children's health and to encourage them to stop smoking. Minimal
      advice (simple, clear, written and oral information on the actors and means of helping to
      stop smoking) is the first step in triggering an attempt to stop smoking. The paediatrician
      seems to be a particularly influential actor since he intervenes at a time when parents are
      trying to improve their child's health. The minimum advice would have an effectiveness of
      2-5% on smoking cessation in general. There is no data on the impact of this minimum advice
      when given by paediatricians. There are also no data on the current prevalence of smoking in
      France among parents of children with various chronic diseases, such as cystic fibrosis or
      diabetes. It is also necessary to describe the smoking habits of parents, as children's
      exposure and its impact on their health depends in particular on where their parents smoke.
observational model: Case-Only
time perspective: Prospective
measure: Smoking prevalence
time frame: 18 months
description: establish the effect of minimal advice (oral + orientation leaflet) given by the paediatrician following children with cystic fibrosis, diabetes or hospitalized for a first episode of bronchiolitis on the parents' smoking habits.
measure: Parental smoking evolution
time frame: 18 months
description: Evolution of parental smoking habits 3 months after this advice by :
Smoking statue number of cigarets/day
arm group label: Experimental
description: A questionnaire on smoking habits was given to all parents of children being followed in consultation for cystic fibrosis or type 1 diabetes, or whose child was hospitalized for the first time for bronchiolitis.
intervention type: Other
intervention name: Tobacco questionnaire
description: A questionnaire on smoking habits was given to all parents of children being followed in consultation for cystic fibrosis or type 1 diabetes, or whose child was hospitalized for the first time for bronchiolitis.
Provision of minimal advice (oral and a leaflet from the anti-smoking centre) to parents who smoke by the paediatrician following the child.
For parents who smoke, evaluation at 3 months of the impact of this minimal advice by another questionnaire during the usual follow-up of the patient at 3 months or by telephone contact.
arm group label: Experimental
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Marie MITTAINE
role: Principal Investigator
affiliation: University Hospital, Toulouse
last name: Marie MITTAINE, MD
phone: 5 34 55 87 37
phone ext: +33
email: mittaine.m@chu-toulouse.fr
last name: Isabelle OLIVIER, PhD
phone: 05-61-77-70-51
phone ext: +33
email: olivier.i@chu-toulouse.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Bronchiolitis