Early Life Intervention in Pediatrics Supported by E-health - SMOKE (ELIPSE-II)

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

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 .

Study Overview

• Status: Recruiting
• Conditions: Smoking Reduction; Asthma in Children; Life Style; Wheezing; Non-Communicable Disease; Behavior, Smoking
• Intervention / Treatment: Behavioral: Life-Style app; Other: Sham Comparator

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 Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthias V. Kopp, Prof. Dr.; Phone Number: +41 31 66 4 13 51; Email: matthias.kopp@insel.ch
• Study Contact Backup: Name: Julian Jakob, Dr.; Phone Number: +41 31 632 12 93; Email: julian.jakob@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Department of Paediatrics, Inselspital, Bern University Hospital
    • Sub-Investigator: Andrea Wyssen, PhD
    • Contact: Julian Jakob, MD; Phone Number: +41 31 632 12 93; Email: julian.jakob@insel.ch
    • Contact: Matthias V. Kopp, Prof, MD; Phone Number: +41 31 66 4 13 51; Email: matthias.kopp@insel.ch
    • Sub-Investigator: Julian Jakob, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Life-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.; Other Names: Smartphone App
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.	Other: Sham 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.; Other Names: Flyer about second-hand smoke exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in protective measures taken by parents to protect children from second-hand smoke exposure	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.	During intervention (week 2-22), post intervention (week 22-23) and follow-up (week 48-49)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance and usability of the app (parent reported outcome)	The usability of the app is assessed using the eHealth App Usability Questionnaire (MAUQ). The questionnaire measures usability on three subscales (ease of use, Interface and satisfaction, usefulness). The MAUQ questionnaire consists of 18 items with a score ranging from 1 to 7. Score 7 means a better result.	At 22 weeks after baseline (Post intervention)
Acceptance of the app	The acceptance of the app is measured by means of dropout rate.	During the intervention (week 2-22)
Usability of the app	The usability of the app is measured by means of how often and how long the parents use the app.	During the intervention (week 2-22)
Number of episodes of airway disease in children	Parents are asked to report any event of airway disease (including any type of upper or lower respiratory tract infection; e.g. otitis media, rhinitis, pharyngitis, acute or chronic bronchitis, protracted bacterial bronchitis, chronic cough, pneumonia).	Baseline, at 22 weeks (Post intervention) and at 48 weeks (Follow-Up) after baseline
Frequency of inhalant medications or antibiotics required for airway disease in children	Parents are asked to report any medical treatment received because of airway disease (includes inhalant drugs, antibiotics, antipyretic medication).	Baseline, at 22 weeks (Post intervention) and at 48 weeks (Follow-Up) after baseline
Amount of inhalant medications or antibiotics required for airway disease in children	Parents are asked to report any medical treatment received because of airway disease (includes inhalant drugs, antibiotics, antipyretic medication).	Baseline, at 22 weeks (Post intervention) and at 48 weeks (Follow-Up) after baseline
Number of episodes of severe airway disease in children requiring hospitalization	Parents are asked about any hospitalization because of airway disease.	Baseline, during the intervention (week 2-22), at 22 weeks (Post intervention) and at 48 weeks (Follow-Up) after baseline
Change from baseline in parental smoking intensity (number of cigarettes smoked per day)	Parents are asked to report their smoking habits (using a questionnaire).	At 22 weeks (Post intervention) and at 48 weeks (Follow-Up) after baseline

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: University of Bern
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2024
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Children; Prevention; eHealth; Secondhand smoke
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Health Behavior; Noncommunicable Diseases; Respiratory Sounds; Smoking; Smoking Reduction
• Other Study ID Numbers: 2023-01615

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No