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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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 .

Eligibility
Participation Requirements
Sex: All
Maximum Age: 5
Healthy Volunteers: t
View:

• 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)

Locations
Other Locations
Switzerland
Department of Paediatrics, Inselspital, Bern University Hospital
RECRUITING
Bern
Contact Information
Primary
Matthias V. Kopp, Prof. Dr.
matthias.kopp@insel.ch
+41 31 66 4 13 51
Backup
Julian Jakob, Dr.
julian.jakob@insel.ch
+41 31 632 12 93
Time Frame
Start Date: 2024-05-07
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 160
Treatments
Experimental: Treatment group (Life-style app)
Parents receive a smartphone app during the main intervention period of 20 weeks. The app (life-style app) aims to promote healthy behaviour through cognitive-behavioural impact factors.
Sham_comparator: Control group
The parents get an information sheet 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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Bern
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov