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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06311162
Other study ID # 2023-01615
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 7, 2024
Est. completion date July 31, 2028

Study information

Verified date May 2024
Source Insel Gruppe AG, University Hospital Bern
Contact Matthias V. Kopp, Prof. Dr.
Phone +41 31 66 4 13 51
Email matthias.kopp@insel.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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 .


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date July 31, 2028
Est. primary completion date August 31, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 5 Years
Eligibility 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


Intervention

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:
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.

Locations

Country Name City State
Switzerland Department of Paediatrics, Inselspital, Bern University Hospital Bern

Sponsors (2)

Lead Sponsor Collaborator
Insel Gruppe AG, University Hospital Bern University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other 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)
Other Acceptance of the app The acceptance of the app is measured by means of dropout rate. During the intervention (week 2-22)
Other 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)
Other 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
Other 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
Other 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
Other 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
Other 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
Primary 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)
Primary 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 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)
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