Babies Living Safe and Smokefree
Status: | Active, not recruiting |
---|---|
Conditions: | Smoking Cessation, Tobacco Consumers |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/2/2019 |
Start Date: | February 2016 |
End Date: | April 2020 |
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 reduce children's exposure to secondhand
tobacco smoke (primary outcome) and promote smoking cessation in mothers (secondary outcome).
Low-income mothers who smoke and their children will be enrolled 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 children 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 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.
multilevel, multimodal intervention designed to reduce children's exposure to secondhand
tobacco smoke (primary outcome) and promote smoking cessation in mothers (secondary outcome).
Low-income mothers who smoke and their children will be enrolled 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 children 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 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.
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
We found this trial at
2
sites
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1801 N Broad St
Philadelphia, Pennsylvania 19122
Philadelphia, Pennsylvania 19122
(215) 204-7000
Principal Investigator: Stephen J Lepore, PhD
Phone: 215-204-0315
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