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

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Wheezing; Non-Communicable Disease; Life Style; Smoking Reduction; Asthma in Children; Behavior, Smoking

Treatments: Behavioral: Life-Style app; Other: Sham Comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT06311162

2023-01615

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: Under 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

Treatment group (Life-style app)

Experimental group

Description:

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.

Treatment:

Behavioral: Life-Style app

Control group

Sham Comparator group

Description:

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.

Treatment:

Other: Sham Comparator