Ignite Creation Date:
2024-05-06 @ 7:47 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02602288
Status:
COMPLETED
Last Update Posted:
2022-03-15
First Post:
2015-11-09
Brief Title:
Babies Living Safe and Smokefree
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
Multilevel Tobacco Intervention in Community Clinics for Underserved Families
Status:
COMPLETED
Status Verified Date:
2022-02
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:
BLiSS
Brief Summary:
The purpose of this randomized controlled trial is to develop and test the efficacy of a multilevel multimodal intervention designed to modify maternal smoking behavior to reduce childrens exposure to secondhand tobacco smoke primary outcome and promote their smoking cessation secondary outcome Low-income mothers who smoke will be enrolled Mothers will be recruited from the supplemental nutrition program Women Infants and Children WIC clinics All mothers visiting WIC clinics will receive a clinic-level intervention which consists of nutrition counselors following an ask advise and refer protocol to identify if their children are exposed to secondhand tobacco smoke advise mothers who smoke about the harms of such exposure and the benefits of reducing exposure and referring mothers to the trial Screened eligible mothers will be consented and randomized to an attention control condition focused on nutrition CTL or to an experimental EXP multimodal behavioral intervention that integrates telebased counseling to promote the reduction of child secondhand smoke exposure SHSE and maternal smoking with an adjunct smoking cessation mobile app and nicotine replacement therapy use The investigators will test the primary hypothesis that relative to children in the CTL condition those in the EXP condition will have lower exposure SHSE as measured by mothers reports and child cotinine levels The investigators will also test the secondary hypothesis that relative to mothers in the CTL condition those in the EXP condition will have higher bioverified 7-day point prevalence quit rates In addition the study will a evaluate if specific psychosocial and behavioral factors-- social support urge coping skills self-efficacy and SHSe protective behaviors--mediate the effects of the EXP intervention on outcomes and b explore whether other residential smokers level of nicotine dependence depressiveanxious symptoms weight concerns intervention dosage and pregnancy status predict outcomes and moderate treatment effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None