Clinical trial NCT06311162: Early Life Intervention in Pediatrics Supported by E-health - SMOKE
Official title: Early Life Intervention in Pediatrics Supported by E-health (ELIPSE II): Coaching Parents to Lower Second-hand Smoke Exposure in Children A Single-blind Randomized Controlled Parallel-group Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Reduction
Asthma in Children
Wheezing
Non-Communicable Disease
Life Style
Behavior, Smoking
Keywords: Secondhand smoke
Children
Prevention
eHealth
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2024-03-15
Enrollment: 160
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind randomized controlled parallel-group clinical trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in urinary levels of cotinine in children
timeFrame: At 22 weeks after baseline (Post intervention)
measure: Change from baseline in urinary levels of cotinine in children
timeFrame: At 48 weeks after baseline (Follow-Up)
Secondary outcomes:
measure: Change from baseline in protective measures taken by parents to protect children from second-hand smoke exposure
timeFrame: During intervention (week 2-22), post intervention (week 22-23) and follow-up (week 48-49)
Other outcomes:
measure: Acceptance and usability of the app (parent reported outcome)
timeFrame: At 22 weeks after baseline (Post intervention)
measure: Acceptance of the app
timeFrame: During the intervention (week 2-22)
measure: Usability of the app
timeFrame: During the intervention (week 2-22)
measure: Number of episodes of airway disease in children
timeFrame: Baseline, at 22 weeks (Post intervention) and at 48 weeks (Follow-Up) after baseline
measure: Frequency of inhalant medications or antibiotics required for airway disease in children
timeFrame: Baseline, at 22 weeks (Post intervention) and at 48 weeks (Follow-Up) after baseline
measure: Amount of inhalant medications or antibiotics required for airway disease in children
timeFrame: Baseline, at 22 weeks (Post intervention) and at 48 weeks (Follow-Up) after baseline
measure: Number of episodes of severe airway disease in children requiring hospitalization
timeFrame: Baseline, during the intervention (week 2-22), at 22 weeks (Post intervention) and at 48 weeks (Follow-Up) after baseline
measure: Change from baseline in parental smoking intensity (number of cigarettes smoked per day)
timeFrame: At 22 weeks (Post intervention) and at 48 weeks (Follow-Up) after baseline
Locations:
city: Bern
country: Switzerland
facility: Department of Paediatrics, Inselspital, Bern University Hospital
Study officials:
affiliation: Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland
name: Matthias V. Kopp, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitäre Psychiatrische Dienste Bern (UPD), University of Bern, Switzerland
name: Michael Kaess, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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