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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04437641
Other study ID # RC31/19/0359
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 22, 2019
Est. completion date December 30, 2021

Study information

Verified date June 2020
Source University Hospital, Toulouse
Contact Marie MITTAINE, MD
Phone 5 34 55 87 37
Email mittaine.m@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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%.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Refusal to participate

- Parent already in the process of quitting smoking

- Adult person under guardianship/curators or safeguard of justice

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Tobacco questionnaire
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.

Locations

Country Name City State
France MITTAINE Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 18 months
Secondary Parental smoking evolution Evolution of parental smoking habits 3 months after this advice by :
Smoking statue number of cigarets/day
18 months
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