Tobacco ConsumptionMUCODIABTABNCT04437641
Impact of Pediatrician Intervention on the Smoking Habits of Parents of Sick Children
An observational study of Tobacco Consumption and Bronchiolitis, run by University Hospital, Toulouse at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tobacco Consumption, Bronchiolitis
- What is being tested?
- Tobacco questionnaire
- Type of treatment
- Pill or oral medicine
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 22 Oct 2019to 30 Dec 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recruitment of parents accompanying paediatric patients followed in consultation or seen in hospital in the departments of pneumology and paediatric diabetology at Toulouse University Hospital. The doctor proposes to the parent to participate in this research and informs him/her: * of the objective, * of the computerised processing of the data concerning him/her that will be collected in the course of this research and also specifies his/her rights of access, opposition and rectification to this data.
Who may be able to join
- Parents of legal age, of children being followed for cystic fibrosis or type 1 diabetes or being hospitalized for the first time for bronchiolitis.
- Having given their non-opposition to participate in the research
- Covered by a social security scheme
Who cannot join
- Refusal to participate
- Parent already in the process of quitting smoking
- Adult person under guardianship/curators or safeguard of justice
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
MITTAINE
Toulouse
Marie MITTAINE, 5 34 55 87 37 ext. +33
Amélie ARROUY, 5 61 77 62 33 ext. +33, arrouy.a@chu-toulouse.fr
About this study
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.
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%.
Read the detailed description
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.
- Conditions
- Tobacco Consumption, Bronchiolitis
- Being tested
- Tobacco questionnaire
- Keywords
- Tobacco Consumption
- Medical subject headings
- Tobacco Use, Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | 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. Receives: Other: Tobacco questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking prevalence
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.
Measured: 18 months
Secondary outcomes (1)
Parental smoking evolution
Evolution of parental smoking habits 3 months after this advice by :
Smoking statue number of cigarets/day
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start22 Oct 2019
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco ConsumptionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie MITTAINE, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437641
- Sponsor's protocol ID
- RC31/19/0359
- Acronym
- MUCODIABTAB
- Status last verified
- Jun 2020
- First submitted
- 26 Mar 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04437641
- Acronym / sponsor ID
- MUCODIABTAB / RC31/19/0359
- Conditions
- Tobacco Consumption, Bronchiolitis
- Keywords
- Tobacco Consumption
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 18 Jun 2020 (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.
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%.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: Tobacco questionnaireA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment of parents accompanying paediatric patients followed in consultation or seen in hospital in the departments of pneumology and paediatric diabetology at Toulouse University Hospital. The doctor proposes to the parent to participate in this research and informs him/her: * of the objective, * of the computerised processing of the data concerning him/her that will be collected in the course of this research and also specifies his/her rights of access, opposition and rectification to this data.
Key inclusion criteria (3 listed)
- Parents of legal age, of children being followed for cystic fibrosis or type 1 diabetes or being hospitalized for the first time for bronchiolitis.
- Having given their non-opposition to participate in the research
- Covered by a social security scheme
Key exclusion criteria (3 listed)
- Refusal to participate
- Parent already in the process of quitting smoking
- Adult person under guardianship/curators or safeguard of justice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobacco questionnaireA 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. | Other | Experimental |
Primary outcome
Smoking prevalence
Time frame: 18 months
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.
1 secondary outcome
Parental smoking evolution
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
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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.
Marie MITTAINE principal investigator
University Hospital, Toulouse
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 Tobacco Consumption and Bronchiolitis, run by University Hospital, Toulouse at 1 site in France.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Jun 2020. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie MITTAINE, MD (5 34 55 87 37 ext. +33, mittaine.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking prevalence (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2020.