Babies Living Safe and Smokefree

NCT ID: NCT02602288

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 396 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2019-10-23

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 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.

Conditions

Second Hand Tobacco Smoke; Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ask, Advise, Refer

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Telephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke

Mobile phone smoking cessation application

Intervention Type: DEVICE

Smartphone based application to support smoking cessation efforts

Nicotine polacrilex

Intervention Type: DRUG

Over the counter nicotine replacement therapy in gum or lozenge form.

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

Group Type: ACTIVE_COMPARATOR

Ask, Advise, Refer

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Telephone counseling to promote nutritious eating practices in the family.

Mobile phone nutrition application

Intervention Type: DEVICE

Smartphone based application to support healthy eating habits

Interventions

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

Intervention Type: BEHAVIORAL

Telebased tobacco counseling

Telephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke

Intervention Type: BEHAVIORAL

Telebased nutrition counseling

Telephone counseling to promote nutritious eating practices in the family.

Intervention Type: BEHAVIORAL

Mobile phone smoking cessation application

Smartphone based application to support smoking cessation efforts

Intervention Type: DEVICE

Mobile phone nutrition application

Smartphone based application to support healthy eating habits

Intervention Type: DEVICE

Nicotine polacrilex

Over the counter nicotine replacement therapy in gum or lozenge form.

Intervention Type: DRUG

Other Intervention Names

nicotine gum, nicotine lozenge

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

N.O.R.T.H., Inc.

INDUSTRY

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen J Lepore, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

Temple University

Philadelphia, Pennsylvania, United States

N.O.R.T.H., Inc.

Philadelphia, Pennsylvania, United States

Countries

United States

References

Collins BN, Lepore SJ, Egleston BL. Eliminating children's tobacco smoke exposure: a pathway to bioverified abstinence among low-income maternal smokers in the Babies Living Safe and Smokefree (BLiSS) trial. J Behav Med. 2023 Dec;46(6):1042-1048. doi: 10.1007/s10865-023-00423-9. Epub 2023 Jun 7.

Reference Type: DERIVED

PMID: 37285107 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35196033 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34255698 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28288601 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

R01CA188813

Identifier Type: NIH

Identifier Source: org_study_id

View Link