|- candidate number||6509|
|- NTR Number||NTR2023|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-sep-2009|
|- Secondary IDs||NL 26349.068.09/MEC 09-2-019 |
|- Public Title||Prevention of passive smoking exposure in children with a high risk of asthma: the results of an individualized, tailored intervention.|
|- Scientific Title||Prevention of passive smoking exposure in children with a high risk of asthma: the results of an individualized, tailored intervention.|
|- hypothesis||An effective intervention towards stopping passive smoke exposure in children is possibly by means of an individualized program with counseling, education, motivational interviewing, and confrontational interviewing with feedback about the urine cotinine levels of the children. |
|- Healt Condition(s) or Problem(s) studied||Asthma, Children, Passive smoking|
|- Inclusion criteria||1. Children aged 0-13 years exposed to passive smoking by one or both parents;|
2. At least one first-degree family member suffering from GP-registered asthma.
|- Exclusion criteria||1. Children who are actively smoking themselves;|
2. Mental retardation or syndromes;
3. Congenital disorders;
4. Children with chronic respiratory diseases like asthma, BPD, cystic fibrosis;
5. Children and parents already receiving professional support for smoking cessation.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||9-jan-2010|
|- planned closingdate||2-jan-2012|
|- Target number of participants||890|
|- Interventions||The participants (N=270 families with one child per family) will be randomized according to clusters into 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, behavioral counseling about stopping passive smoking, and feedback on the urine cotinine of the children. |
|- Primary outcome||The total number of passive smoking cessation, and the urine cotinine levels of the children and parents. |
|- Secondary outcome||1. Nicotine levels in the house. Passive sampling diffusion monitors will be placed in the participants’ homes. Sampling will be measured at 0, 3, 6, 9, and 12 months of follow-up;|
2. Number of reported smoked cigarettes/week at home and stopping active smoking, will be measured by a standard questionnaire;
3. Questionnaire on respiratory complaints and infections;
4. Quality of life, measured with FSII questionnaire;
5. The children’s’ lung function will be measured at home at 0, 3, 6, 9, and 12 months of follow-up;
6. Questionnaire at the end of the study (12 months) concerning the participants’ evaluation of the intervention.
|- Timepoints||1. September 2009 - December 2009: Recruitment;|
2. February 2010 - April 2010: Pilot;
3. September 2010 - February 2012: Intervention.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MD. Sasha Hutchinson|
|- CONTACT for SCIENTIFIC QUERIES||MD. Phd. Edward Dompeling|
|- Sponsor/Initiator ||University Maastricht (UM), CAPHRI Research Institute|
(Source(s) of Monetary or Material Support)
|Netherlands Asthma Foundation|
|- Brief 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. The current study aims at testing an innovative, implementable, effective intervention strategy towards stopping of passive smoke exposure in children at risk for asthma. Sudy design: one-year follow-up randomized controlled intervention study. The primary research questions are:|
1. What is the effectiveness of an intervention program towards stopping of passive smoke exposure in children with a positive family history of asthma in the first degree? Does stopping passive smoking persist after the intervention?
2. What barriers do parents encounter with stopping of passive smoking and how can we overcome these barriers?
|- Main changes (audit trail)|
|- RECORD||23-sep-2009 - 29-okt-2009|