NCT Number: NCT06311162
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 .
Interested in participating?
Request InfoUp to 5 year
All sexes
Interventional
Not applicable
Bern, 3010, Switzerland
Location status: Recruiting
Andrea Wyssen, PhD
SUB_INVESTIGATOR
Julian Jakob, MD
CONTACT
Julian Jakob, MD
SUB_INVESTIGATOR
Matthias V. Kopp, Prof, MD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: At 22 weeks after baseline (Post intervention)
Change in exposure to second-hand smoke exposure assessed by urinary levels of cotinine
Time frame: At 48 weeks after baseline (Follow-Up)
Change in exposure to second-hand smoke exposure assessed by urinary levels of cotinine
Time frame: 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.
Time frame: At 22 weeks after baseline (Post intervention)
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.
Time frame: During the intervention (week 2-22)
The acceptance of the app is measured by means of dropout rate.
Time frame: During the intervention (week 2-22)
The usability of the app is measured by means of how often and how long the parents use the app.
Time frame: Baseline, at 22 weeks (Post intervention) and at 48 weeks (Follow-Up) after baseline
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).
Time frame: Baseline, at 22 weeks (Post intervention) and at 48 weeks (Follow-Up) after baseline
Parents are asked to report any medical treatment received because of airway disease (includes inhalant drugs, antibiotics, antipyretic medication).
Time frame: Baseline, at 22 weeks (Post intervention) and at 48 weeks (Follow-Up) after baseline
Parents are asked to report any medical treatment received because of airway disease (includes inhalant drugs, antibiotics, antipyretic medication).
Time frame: Baseline, during the intervention (week 2-22), at 22 weeks (Post intervention) and at 48 weeks (Follow-Up) after baseline
Parents are asked about any hospitalization because of airway disease.
Time frame: At 22 weeks (Post intervention) and at 48 weeks (Follow-Up) after baseline
Parents are asked to report their smoking habits (using a questionnaire).
Contact information is provided by the study sponsor or research team.
Julian Jakob, Dr.
CONTACT
Matthias V. Kopp, Prof. Dr.
CONTACT
Insel Gruppe AG, University Hospital Bern
Other
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
Acronym: ELIPSE-II
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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