NCT02602288

Babies Living Safe and Smokefree

Multilevel Tobacco Intervention in Community Clinics for Underserved Families

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 396 (actual)
• Sponsor: Temple University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
BEHAVIORAL	Telebased nutrition counseling	Telephone counseling to promote nutritious eating practices in the family.
DEVICE	Mobile phone smoking cessation application	Smartphone based application to support smoking cessation efforts
DEVICE	Mobile phone nutrition application	Smartphone based application to support healthy eating habits
DRUG	Nicotine polacrilex	Over the counter nicotine replacement therapy in gum or lozenge form.

Timeline

• Start date: 2016-02-01
• Primary completion: 2019-10-23
• Completion: 2019-10-23
• First posted: 2015-11-11
• Last updated: 2022-03-15
• Results posted: 2022-03-15

Locations

2 sites across 1 country: United States