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

NCT06311162 | Recruiting

• 1 other identifier: 2023-01615
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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 .

Conditions

Smoking Reduction; Asthma in Children; Wheezing; Non-Communicable Disease; Life Style; Behavior, Smoking

Keywords

Secondhand smoke; Children; Prevention; eHealth

Outcome Measures

Primary Outcomes (2)

• Change from baseline in urinary levels of cotinine in children

  Change in exposure to second-hand smoke exposure assessed by urinary levels of cotinine

  At 22 weeks after baseline (Post intervention)

• Change from baseline in urinary levels of cotinine in children

  Change in exposure to second-hand smoke exposure assessed by urinary levels of cotinine

  At 48 weeks after baseline (Follow-Up)

Secondary Outcomes (1)

• 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)

Other Outcomes (8)

• Acceptance and usability of the app (parent reported outcome)

  At 22 weeks after baseline (Post intervention)

• Acceptance of the app

  During the intervention (week 2-22)

• Usability of the app

  During the intervention (week 2-22)

Study Arms (2)

Treatment group (Life-style app)

EXPERIMENTAL

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.

Behavioral: Life-Style app

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.

Other: Sham Comparator

Interventions

Life-Style app BEHAVIORAL

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.

Also known as: Smartphone App

Treatment group (Life-style app)

Sham Comparator OTHER

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.

Also known as: Flyer about second-hand smoke exposure

Control group

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Participation in another study/trial targeting similar outcomes
• Participation in an active smoking cessation programme

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (1)

Department of Paediatrics, Inselspital, Bern University Hospital

Bern, 3010, Switzerland

RECRUITING

Related Publications (1)

• Koch A, Wyssen A, Haupt C, Hammelbeck J, van Dorland HA, Fluck CE, Latzin P, Saner C, Jakob J, Kaess M, Kopp MV. Early Life Intervention in Paediatrics Supported by E-Health (ELIPSE)-a coaching app for parents to reduce obesity and second-hand smoke exposure in children: study protocols for two parallel-group randomised controlled trials. Trials. 2025 Nov 18;26(1):520. doi: 10.1186/s13063-025-09251-5.

  PMID: 41254719 DERIVED

MeSH Terms

Conditions

Smoking Reduction; Respiratory Sounds; Noncommunicable Diseases; Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Matthias V. Kopp, Prof. Dr.

  Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland

  PRINCIPAL INVESTIGATOR

• Michael Kaess, Prof. Dr.

  Universitäre Psychiatrische Dienste Bern (UPD), University of Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias V. Kopp, Prof. Dr.

CONTACT

+41 31 66 4 13 51; matthias.kopp@insel.ch

Julian Jakob, Dr.

CONTACT

+41 31 632 12 93; julian.jakob@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The study team members who are conducting assessments on the participants remain blinded to the treatment allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blind randomized controlled parallel-group clinical trial

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 15, 2024
• Study Start: May 7, 2024
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)