Clinical trial NCT02602288: Babies Living Safe and Smokefree
Official title: Multilevel Tobacco Intervention in Community Clinics for Underserved Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Second Hand Tobacco Smoke
Nicotine Dependence
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: N.O.R.T.H., Inc.
First posted: 2015-11-11
Enrollment: 396
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Child Urine Cotinine
timeFrame: 3 months and 12 months
measure: Cigarettes/Day
timeFrame: 3 months and 12 months
Secondary outcomes:
measure: Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence
timeFrame: 7 days prior to 3 month and 12 month assessments
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Philadelphia
country: United States
facility: N.O.R.T.H., Inc.
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Stephen J Lepore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.