Babies Living Safe and Smokefree

Study Overview
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Brief Summary
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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.

Official Title
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Multilevel Tobacco Intervention in Community Clinics for Underserved Families

Conditions
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Second Hand Tobacco Smoke, Nicotine Dependence

Intervention / Treatment
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* Behavioral: Ask, Advise, Refer
* Behavioral: Telebased tobacco counseling
* Behavioral: Telebased nutrition counseling
* Device: Mobile phone smoking cessation application
* Device: Mobile phone nutrition application
* Drug: Nicotine polacrilex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AAR+Behavioral Intervention (EXP)<br>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. | Behavioral: Ask, Advise, Refer<br>* WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources<br>Behavioral: Telebased tobacco counseling<br>* Telephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke<br>Device: Mobile phone smoking cessation application<br>* Smartphone based application to support smoking cessation efforts<br>Drug: Nicotine polacrilex<br>* Over the counter nicotine replacement therapy in gum or lozenge form.<br>* Other names: nicotine gum, nicotine lozenge;|
| Active Comparator: AAR+Attention Control Intervention (CTL)<br>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 | Behavioral: Ask, Advise, Refer<br>* WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources<br>Behavioral: Telebased nutrition counseling<br>* Telephone counseling to promote nutritious eating practices in the family.<br>Device: Mobile phone nutrition application<br>* Smartphone based application to support healthy eating habits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |