Babies Living Safe and Smokefree (BLiSS)

Multilevel Tobacco Intervention in Community Clinics for Underserved Families

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.

Study Overview

• Status: Completed
• Conditions: Nicotine Dependence; Second Hand Tobacco Smoke
• Intervention / Treatment: Behavioral: Ask, Advise, Refer; Behavioral: Telebased tobacco counseling; Device: Mobile phone smoking cessation application; Drug: Nicotine polacrilex; Behavioral: Telebased nutrition counseling; Device: Mobile phone nutrition application

• Study Type: Interventional
• Enrollment (Actual): 396
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19122
      • Temple University
    • Philadelphia, Pennsylvania, United States, 19132
      • N.O.R.T.H., Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: N.O.R.T.H., Inc.
• Investigators: Principal Investigator: Stephen J Lepore, PhD, Temple University

Publications and helpful links

General Publications

• Collins BN, Lepore SJ, Egleston BL. Multilevel Intervention for Low-Income Maternal Smokers in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Am J Public Health. 2022 Mar;112(3):472-481. doi: 10.2105/AJPH.2021.306601.
• Lepore SJ, Collins BN, Killam HW, Barry B. Supportive Accountability and Mobile App Use in a Tobacco Control Intervention Targeting Low-Income Minority Mothers Who Smoke: Observational Study. JMIR Mhealth Uhealth. 2021 Jul 2;9(7):e28175. doi: 10.2196/28175.
• Collins BN, Lepore SJ. Babies Living Safe & Smokefree: randomized controlled trial of a multilevel multimodal behavioral intervention to reduce low-income children's tobacco smoke exposure. BMC Public Health. 2017 Mar 14;17(1):249. doi: 10.1186/s12889-017-4145-7.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): October 23, 2019
• Study Completion (Actual): October 23, 2019

Study Registration Dates

• First Submitted: November 9, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 11, 2015

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: R01CA188813 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO