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

NCT ID: NCT06311162

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-07
• Study Completion Date: 2028-07-31

Brief 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 .

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Treatment group (Life-style app)

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.

Group Type: EXPERIMENTAL

Life-Style app

Intervention Type: 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.

Control group

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.

Group Type: SHAM_COMPARATOR

Sham Comparator

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

Smartphone App; Flyer about second-hand smoke exposure

Eligibility Criteria

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

• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bern

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthias V. Kopp, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland

Michael Kaess, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitäre Psychiatrische Dienste Bern (UPD), University of Bern, Switzerland

Locations

Department of Paediatrics, Inselspital, Bern University Hospital

Bern, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Matthias V. Kopp, Prof. Dr.

Role: CONTACT

matthias.kopp@insel.ch

+41 31 66 4 13 51

Julian Jakob, Dr.

Role: CONTACT

julian.jakob@insel.ch

+41 31 632 12 93

Facility Contacts

Julian Jakob, MD

Role: primary

julian.jakob@insel.ch

+41 31 632 12 93

Matthias V. Kopp, Prof, MD

Role: backup

matthias.kopp@insel.ch

+41 31 66 4 13 51

Other Identifiers

2023-01615

Identifier Type: -

Identifier Source: org_study_id