Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311162
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-03-07
Brief Title:
Early Life Intervention in Pediatrics Supported by E-health - SMOKE
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELIPSE-II
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 ie 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 childrens university hospital and in private practices in Bern and randomly 11 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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None