Babies Living Safe and Smokefree (BLiSS)

Temple University

Status: Completed

Conditions: Nicotine Dependence; Second Hand Tobacco Smoke

Treatments: Behavioral: Telebased tobacco counseling; Behavioral: Telebased nutrition counseling; Device: Mobile phone smoking cessation application; Device: Mobile phone nutrition application; Drug: Nicotine polacrilex; Behavioral: Ask, Advise, Refer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02602288

R01CA188813

Details and patient eligibility

About

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.

Enrollment: 396 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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396 participants in 2 patient groups

AAR+Behavioral Intervention (EXP)

Experimental group

Description:

Ask Advise Refer (AAR): 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. Mobile phone smoking cessation application: Smartphone based application to support smoking cessation efforts. Nicotine polacrilex: Over the counter nicotine replacement therapy in gum or lozenge form.

Treatment:

Drug: Nicotine polacrilex

Device: Mobile phone smoking cessation application

Behavioral: Ask, Advise, Refer

Behavioral: Telebased tobacco counseling

AAR+Attention Control Intervention (CTL)

Active Comparator group

Description:

Ask Advise Refer (AAR): WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources. Telebased nutrition counseling: Telephone counseling to promote nutritious eating practices in the family. Mobile phone nutrition application: Smartphone based application to support healthy eating habits

Treatment:

Behavioral: Telebased nutrition counseling

Device: Mobile phone nutrition application

Behavioral: Ask, Advise, Refer