Babies Living Safe and Smokefree

NCT02602288 | Completed Results DMC

• 1 other identifier: R01CA188813
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence

  7 days prior to 3 month and 12 month assessments

Study Arms (2)

AAR+Behavioral Intervention (EXP)

EXPERIMENTAL

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; Behavioral: Telebased tobacco counseling; Device: Mobile phone smoking cessation application; Drug: Nicotine polacrilex

AAR+Attention Control Intervention (CTL)

ACTIVE COMPARATOR

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; Behavioral: Telebased nutrition counseling; Device: Mobile phone nutrition application

Interventions

Ask, Advise, Refer BEHAVIORAL

WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources

AAR+Attention Control Intervention (CTL); AAR+Behavioral Intervention (EXP)

Telebased tobacco counseling BEHAVIORAL

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

AAR+Behavioral Intervention (EXP)

Telebased nutrition counseling BEHAVIORAL

Telephone counseling to promote nutritious eating practices in the family.

AAR+Attention Control Intervention (CTL)

Mobile phone smoking cessation application DEVICE

Smartphone based application to support smoking cessation efforts

AAR+Behavioral Intervention (EXP)

Mobile phone nutrition application DEVICE

Smartphone based application to support healthy eating habits

AAR+Attention Control Intervention (CTL)

Nicotine polacrilex DRUG

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

Also known as: nicotine gum, nicotine lozenge

AAR+Behavioral Intervention (EXP)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Temple University: lead
• N.O.R.T.H., Inc.: collaborator

Study Sites (2)

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

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

Philadelphia, Pennsylvania, 19132, United States

Location

Related Publications (4)

• 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.

  PMID: 37285107 DERIVED

• 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.

  PMID: 35196033 DERIVED

• 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.

  PMID: 34255698 DERIVED

• 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.

  PMID: 28288601 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

corticosteroid hormone-induced factor; Referral and Consultation; Tobacco Use Cessation Devices; Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration; Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

Limited generalizability of findings due to high rates of ineligibility (27.7%) and inability to contact (22.7%) among maternal smokers referred to the trial by WIC nutrition professionals who provided the clinic-level intervention.

Results Point of Contact

• Title: Dr. Stephen Lepore
• Organization: Temple University

slepore@temple.edu

215-204-9422

Study Officials

• Stephen J Lepore, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 11, 2015
• Study Start: February 1, 2016
• Primary Completion: October 23, 2019
• Study Completion: October 23, 2019
• Last Updated: March 15, 2022
• Results First Posted: March 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)