Smoking ReductionELIPSE-IINCT06311162
Early Life Intervention in Pediatrics Supported by E-health - SMOKE
A study testing Life-Style app in people with Smoking Reduction and Asthma in Children, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Reduction, Asthma in Children, Wheezing
- What is being tested?
- Life-Style app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 May 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- Participation in another study/trial targeting similar outcomes
- Participation in an active smoking cessation programme
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Paediatrics, Inselspital, Bern University Hospital
Bern, 3010
Julian Jakob, MD, +41 31 632 12 93, julian.jakob@insel.ch
Matthias V. Kopp, Prof, MD, +41 31 66 4 13 51, matthias.kopp@insel.ch
About this study
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
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 .
Read the 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.
- Conditions
- Smoking Reduction, Asthma in Children, Wheezing, Non-Communicable Disease, Life Style, Behavior, Smoking
- Being tested
- Life-Style app, Sham Comparator
- Keywords
- Secondhand smoke, Children, Prevention, eHealth
- Medical subject headings
- Smoking Reduction, Respiratory Sounds, Noncommunicable Diseases, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life-Style appBehavioural
Also called Smartphone 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.
Sham ComparatorOther
Also called Flyer about second-hand smoke exposure
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in urinary levels of cotinine in children
Change in exposure to second-hand smoke exposure assessed by urinary levels of cotinine
Measured: 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
Measured: 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
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.
Measured: During intervention (week 2-22), post intervention (week 22-23) and follow-up (week 48-49)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start7 May 2024
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking ReductionStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind randomized controlled parallel-group clinical trial
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Matthias V. Kopp, Prof. Dr., Principal investigator, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, SwitzerlandMichael Kaess, Prof. Dr., Principal investigator, Universitäre Psychiatrische Dienste Bern (UPD), University of Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311162
- Sponsor's protocol ID
- 2023-01615
- Other IDs
- 2023
- Acronym
- ELIPSE-II
- Status last verified
- Apr 2026
- First submitted
- 7 Mar 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41254719
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06311162
- Acronym / sponsor ID
- ELIPSE-II / 2023-01615
- Conditions
- Smoking Reduction, Asthma in Children, Wheezing, Non-Communicable Disease, Life Style, Behavior, Smoking
- Keywords
- Secondhand smoke, Children, Prevention, eHealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 7 May 2024 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Single-blind randomized controlled parallel-group clinical trial
| Arm | Type | Receives |
|---|---|---|
| Treatment group (Life-style app) | Experimental | Behavioral: Life-Style appParents 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 | Other: Sham ComparatorThe 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. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Participation in another study/trial targeting similar outcomes
- Participation in an active smoking cessation programme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life-Style appAlso: Smartphone AppThe 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. | Behavioural | Treatment group (Life-style app) |
| Sham ComparatorAlso: Flyer about second-hand smoke exposureThe 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 | Control group |
Primary outcome
Change from baseline in urinary levels of cotinine in children
Time frame: At 22 weeks after baseline (Post intervention)
Change in exposure to second-hand smoke exposure assessed by urinary levels of cotinine
Change from baseline in urinary levels of cotinine in children
Time frame: At 48 weeks after baseline (Follow-Up)
Change in exposure to second-hand smoke exposure assessed by urinary levels of cotinine
1 secondary outcome
Change from baseline in protective measures taken by parents to protect children from second-hand smoke exposure
Time frame: During intervention (week 2-22), post intervention (week 22-23) and follow-up (week 48-49)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 41254719Koch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthias V. Kopp, Prof. Dr. principal investigator
Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland
Michael Kaess, Prof. Dr. principal investigator
Universitäre Psychiatrische Dienste Bern (UPD), University of Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life-Style app in people with Smoking Reduction and Asthma in Children, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthias V. Kopp, Prof. Dr. (+41 31 66 4 13 51, matthias.kopp@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in urinary levels of cotinine in children (time frame: At 22 weeks after baseline (Post intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06311162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.