Early Life Intervention in Pediatrics Supported by E-health - SMOKE

Not Applicable

Recruiting

• Conditions: Asthma in Children; Behavior, Smoking; Life Style; Smoking Reduction; Non-Communicable Disease; Wheezing
• Interventions: Behavioral: Life-Style app; Other: Sham Comparator

• Registration Number: NCT06311162
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-07
• Study First Posted: 2024-03-15
• Status Verified: 2024-05
• Study Start: 2024-05-07
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2027-08-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group (Life-style app)	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.
Control group	Sham Comparator	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in urinary levels of cotinine in children	At 48 weeks after baseline (Follow-Up)	Change in exposure to second-hand smoke exposure assessed by urinary levels of cotinine

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Paediatrics, Inselspital, Bern University Hospital; 🇨🇭 Bern, Switzerland