Babies Living Safe and Smokefree

Nicotine Dependence Clinical Trial

— BLiSS  

Official title:

Multilevel Tobacco Intervention in Community Clinics for Underserved Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02602288
• Other study ID #: R01CA188813
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: October 23, 2019

Study information

• Verified date: February 2022
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 children's 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, depressive/anxious symptoms, weight concerns, intervention dosage, and pregnancy status predict outcomes and moderate treatment effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: October 23, 2019
• Est. primary completion date: October 23, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English speaking
• female
• at least 18 years of age
• parent or legal guardian of child under 6 yrs old who lives with them at least 4 days/wk
• smokes

Exclusion Criteria:

• non-nicotine drug dependence
• active psychiatric disturbance (bipolar, schizophrenia, psychosis)
• inadequate health literacy
• pregnant
• no smartphone

Related Conditions & MeSH terms

• Nicotine Dependence
• Second Hand Tobacco Smoke
• Tobacco Use Disorder

Intervention

Behavioral:
• Ask, Advise, Refer
WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources
• Telebased tobacco counseling
Telephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke
• Telebased nutrition counseling
Telephone counseling to promote nutritious eating practices in the family.

Device:
• Mobile phone smoking cessation application
Smartphone based application to support smoking cessation efforts
• Mobile phone nutrition application
Smartphone based application to support healthy eating habits

Drug:
• Nicotine polacrilex
Over the counter nicotine replacement therapy in gum or lozenge form.

Locations

Country	Name	City	State
United States	N.O.R.T.H., Inc.	Philadelphia	Pennsylvania
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	N.O.R.T.H., Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Urine Cotinine	Child urine cotinine is a biomarker for assessing secondhand smoke exposure. The investigators anticipate the EXP group will evidence a greater reduction in child urine cotinine over time than the CTL group. Cotinine values were log transformed to normalize distributions.	3 months and 12 months
Primary	Cigarettes/Day	Parental report of cigarettes child is exposed to each day in the home and car and other locations by all sources during the 7 days prior to assessment. The investigators anticipate the EXP group will evidence greater reductions in child secondhand smoke exposure over time than the CTL group.	3 months and 12 months
Secondary	Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence	When a participant reports smoking abstinence, the investigators will bioverify their smoking status.	7 days prior to 3 month and 12 month assessments