Asthma in Children, Behavior, Smoking, Life Style, Non-Communicable Disease, Smoking Reduction, Wheezing
Conditions
Keywords
Secondhand smoke, Children, Prevention, eHealth
Brief summary
Unrestricted parental smoking habits are lifestyle risk behaviors associated with chronic, systemic inflammation, which promotes the pathogenesis of non-communicable diseases (NCDs). Exposure to secondhand tobacco smoke in early life contributes to the development of specific NCDs in children, i.e. asthma. Early preventive measures to improve lifestyle behavior in parents are therefore of utmost importance. The aim of ELIPSE-II is to assess whether an eHealth application intervention for parents is feasible and efficacious in lowering levels of urinary cotinine as a measure of second-hand smoke exposure in their children .
Detailed description
ELIPSE-II represents a single-blind randomized controlled parallel-group clinical trial. In total, 160 children, \<6 years of age with exposure to second-hand smoke at home will be included. Children will be recruited at the children's university hospital and in private practices in Bern, and randomly (1:1) assigned to a control and intervention group. All participants receive treatment-as-usual (TAU), parents of participants in the intervention group additionally receive a smartphone application (lifestyle app) for 20 weeks. The app aims to promote healthy behavior through cognitive-behavioral impact factors (i.e., psychoeducation, goal setting), that are applied by a psychologist via structured feedback. Single-blinded assessments will be conducted at baseline, following the intervention period of 20 weeks, and at 6-month follow-up after the end of the intervention. The primary endpoint is reduction of exposure to second-hand smoke exposure assessed by urinary levels of cotinine. Secondary endpoints in ELIPSE-II include changes in parental smoking habits and effects of the intervention on infants' respiratory health. A further endpoint is acceptance and usability of the app.
Interventions
BEHAVIORALLife-Style app
The modules of the Life-Style app are introduced and unlocked sequentially during the first weeks of the intervention phase. Afterwards the modules are fully available. Duration and frequency of app-use is not limited. The parents are accompanied by a coach through the app, who gives regular structured feedback and individual inputs. The coach has access to all data collected in the app.
OTHERSham Comparator
The parents get a flyer with information on second-hand smoke exposure and references to smoking cessation programs, and do not have an active app during the main intervention period.
Sponsors
Insel Gruppe AG, University Hospital Bern
University of Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)
Masking description
The study team members who are conducting assessments on the participants remain blinded to the treatment allocation.
Intervention model description
Single-blind randomized controlled parallel-group clinical trial
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: younger than 6 years * Exposed to second-hand smoke at home (at least one parent smoking) * German speaking parent * All sex and ethnic backgrounds * Signed informed consent form from parent * Children live/grow-up in the same household as the parental participant * Referred by a health care professional (e.g. physician, midwife, nurse, other professions)
Exclusion criteria
* Participation in another study/trial targeting similar outcomes * Participation in an active smoking cessation programme
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in urinary levels of cotinine in children | At 22 weeks after baseline (Post intervention) | Change in exposure to second-hand smoke exposure assessed by urinary levels of cotinine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in protective measures taken by parents to protect children from second-hand smoke exposure | During intervention (week 2-22), post intervention (week 22-23) and follow-up (week 48-49) | Parents are asked (using a questionnaire) about the measures taken to protect children from second-hand smoke exposure at baseline, during the intervention, postintervention and follow-up. Protective measures assessed include washing hands, smoking outside (including not smoking in the car), changing clothes after smoking). The questionnaire consists of five items (protective measures) with a score ranging from 1 to 5. Score 5 means a better result. |
Countries
Switzerland
Contacts
CONTACTMatthias V. Kopp, Prof. Dr.
CONTACTJulian Jakob, Dr.
PRINCIPAL_INVESTIGATORMatthias V. Kopp, Prof. Dr.
Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland
PRINCIPAL_INVESTIGATORMichael Kaess, Prof. Dr.
Universitäre Psychiatrische Dienste Bern (UPD), University of Bern, Switzerland
Outcome results
None listed