NCT04437641

Brief 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%.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

2.2 years

First QC Date

March 26, 2020

Last Update Submit

June 16, 2020

Conditions

Keywords

Tobacco Consumption

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Parental smoking evolution

    18 months

Study Arms (1)

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.

Other: Tobacco questionnaire

Interventions

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.

Experimental

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Refusal to participate
  • Parent already in the process of quitting smoking
  • Adult person under guardianship/curators or safeguard of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MITTAINE

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Tobacco UseBronchiolitis

Condition Hierarchy (Ancestors)

BehaviorBronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Marie MITTAINE

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle OLIVIER, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2020

First Posted

June 18, 2020

Study Start

October 22, 2019

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

June 18, 2020

Record last verified: 2020-06

Locations