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NCT Number: NCT06311162

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

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 .

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Key information

Conditions

Smoking Reduction Asthma in Children Behavior Behavior, Smoking Disease Attributes Health Behavior Life Style Non-communicable Disease Noncommunicable Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Sounds Signs and Symptoms Signs and Symptoms, Respiratory Smoking Wheezing

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Paediatrics, Inselspital, Bern University Hospital

Bern, 3010, Switzerland

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Smartphone 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.

Other names: Flyer about second-hand smoke exposure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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)

    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.

Other outcomes

  1. Acceptance and usability of the app (parent reported outcome)

    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.

  2. Acceptance of the app

    Time frame: During the intervention (week 2-22)

    The acceptance of the app is measured by means of dropout rate.

  3. Usability of the app

    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.

  4. Number of episodes of airway disease in children

    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).

  5. Frequency of inhalant medications or antibiotics required for airway disease in children

    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).

  6. Amount of inhalant medications or antibiotics required for airway disease in children

    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).

  7. Number of episodes of severe airway disease in children requiring hospitalization

    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.

  8. Change from baseline in parental smoking intensity (number of cigarettes smoked per day)

    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).

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • University of Bern

Registry information

Official study 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

Acronym: ELIPSE-II

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 15, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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