The current proposal aims at testing an innovative, implementable, effective intervention strategy towards stopping of passive smoke exposure in children at risk for asthma.
ID
Source
Brief title
Condition
- Other condition
- Respiratory disorders NEC
- Lifestyle issues
Synonym
Health condition
passief roken
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures include urine cotinine levels of the child and the
parents, stopping of passive smoking, and number os smoked cigarettes/week at
home.
Secondary outcome
Secondary outcome measures are respiratory complaints and infections, nicotine
levels a home, quality of life, and lung function.
Background summary
Exposure to passive smoking is a huge problem worldwide. Especially children at
risk for asthma are sensitive to the effects of passive smoking exposure. The
WHO estimates that worldwide about 50% of children are exposed to passive
smoking. The health effects of passive smoke exposure 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, and even more
meningococcal septic shock syndrome. From earlier studies in the Netherlands
(PIAMA, PREVASC, RAKKER) it is evident that 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 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 second-hand smoking at home in the group of vulnerable children.
Prevention of passive smoking is not easy to accomplish. However, from the
literature, it can be derived that an individualized, subject-tailored program
with repeated contacts, attention for barriers and needs of parents,
motivational interviewing, and confrontational feed-back about urine cotinine
levels has a high chance on being effective. Such an intervention incorporates
successful aspects of earlier intervention studies on this topic.
Study objective
The current proposal aims at testing an innovative, implementable, effective
intervention strategy towards stopping of passive smoke exposure in children at
risk for asthma.
Study design
One-year follow-up randomised controlled intervention study.
Intervention
The participants will be randomised in two groups: a control group receiving
*standard usual care*, and an active intervention group with an intervention
strategy during 6 months. The intervention is given by a trained practice nurse
and consists of motivational interviewing, behavioural counselling about
stopping passive smoking, and feedback about the urine cotinine of the
children.
Study burden and risks
The nature and extent of the burden associated with participation is limited to
six counselling sessions with the practice nurse, each lasting no longer than
60 minutes, and questionnaires on smoking behaviour, quality of life,
respiratory symptoms and infections, measured at baseline, 3, 6, 9, and 12
months. These questionnaires will not take longer than 20-30 minutes to
complete. Furthermore, parents* and children*s urine samples will be collected
at baseline, 3, 6 ,9, and 12 months. The household nicotine level at baseline
and 12 months, and the children*s lung function will be measured at baseline,
3, 6, 9, and 12 months. There are no risks associated with participation. The
intervention and other study measures are non-invasive. The intervention is
more likely to have a beneficial effect on the participants, helping the
cessation of second-hand smoking at home in children with a high risk on
asthma.
Postbus 5800
6202 AZ Maastricht
NL
Postbus 5800
6202 AZ Maastricht
NL
Listed location countries
Age
Inclusion criteria
Children aged 0 to 13 years, with passive smoking exposure and a positive family history of asthma in the first degree relatives.
Exclusion criteria
mental retardation, respiratory diseases, children who smoke themselves, parents receiving treatment for passive/active smoking cessation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL26349.068.09 |
OMON | NL-OMON22062 |
OMON | NL-OMON24711 |