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ID
Source
Brief title
Health condition
passive smoke exposure, environmental tobacco smoke, asthma, parents stopping passive smoke exposure, children
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is the percentage of families with passive smoking cessation in children (measured via urine cotinine levels of the children and parental self-reports). Stopping passive smoking exposure at home is defined as the cessation of passive smoke exposure to children for at least 6 months after quit date. This can be achieved by parents smoking outside the house, by stopping active smoking or less ideal, smoking in a room where the child does not come.
Secondary outcome
Secondary outcome measures are respiratory complaints and infections, nicotine levels at home, quality of life and lung function of the children.
Background summary
Exposure to passive smoking is a huge problem world-wide. The WHO estimates that about 50% of children are exposed to passive smoking globally. The health effects of passive smoking in children are huge: on average, they have 30-40% more respiratory infections, a higher chance on asthma-like symptoms and more severe asthma, more episodes of acute bronchitis, a two times higher risk on ‘Sudden Infant Death syndrome (SIDS)’, and even more meningococcal septic shock syndrome. From earlier studies in the Netherlands (PIAMA, PREVASC, RAKKER) it is evident that even 30% of children at high risk for asthma are exposed to passive smoking. We recently found that children aged 0-2 years with a first degree family member with asthma and passive smoke exposure had a 6 to 7 times higher risk on ‘wheezing ever’ or ‘attacks of wheezing’ than children without asthma in the first degree. This underlines the importance of effective prevention of passive smoking at home in this group of vulnerable children. The purpose of this study is to test the effectiveness of a new intervention. The intervention is an individualized, subject-tailored program with repeated contacts, including motivational interviewing, attention for barriers and needs of parents, and feedback on the children’s urine cotinine levels and lung functions. Such an innovative approach is a further development of existing knowledge in the literature and has a high chance on being effective.
Study objective
An effective intervention towards stopping passive smoke exposure in children is possible by means of an individualized program with repeated counseling, education, motivational interviewing, and by promoting parental awareness with feedback about the lung function of the children and their urine cotinine levels.
Study design
Lung function and cotinine measurements will be done at time points 0, 3, 6, 9 and 12 months.
The intervention group will receive the intervention during 6 months; from time point 1 month until 6 months.
Intervention
Two hundred families (1child per family) are randomized into two groups: a control group, and an active intervention group. Stratification for ‘age’ will occur. The control group receives ‘usual care’ with no extra visits or extra information about health effects of smoking, other than standard usual care according to the standards of the Dutch Society of General Practitioners (NHG). The active intervention group receives an intervention strategy given by two trained practice nurses at home. The intervention consists of 6 counseling sessions during six months, each lasting about 1hour. The intervention consists of motivational interviewing and feedback on the children’s' lung function and urine cotinine measurements.
PO Box 5800
Sasha Hutchinson
Research Institute CAPHRI, Dept. fo Pediatric Pulmonology
PO Box 5800
Maastricht 6202 AZ
The Netherlands
+ 31 (0) 43-3874282
sasha.hutchinson@mumc.nl
PO Box 5800
Sasha Hutchinson
Research Institute CAPHRI, Dept. fo Pediatric Pulmonology
PO Box 5800
Maastricht 6202 AZ
The Netherlands
+ 31 (0) 43-3874282
sasha.hutchinson@mumc.nl
Inclusion criteria
Children aged 0-13 years with passive smoke exposure at home and high risk of asthma (asthma in the first degree).
Exclusion criteria
1. Children who are currently smoking themselves;
2. Parents already receiving professional help for smoking cessation;
3. Children with diagnosis of: Asthma, congenital malformations of the airways or other chronic lung diseases like CF or BPD, mental retardation or syndromes, heart disease.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2514 |
| NTR-old | NTR2632 |
| CCMO | NL26349.068.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON37213 |