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Babies Living Safe and Smokefree (BLiSS)

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ClinicalTrials.gov Identifier: NCT02602288
Recruitment Status : Recruiting
First Posted : November 11, 2015
Last Update Posted : April 11, 2018
Sponsor:
Collaborator:
N.O.R.T.H., Inc.
Information provided by (Responsible Party):
Temple University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Second Hand Tobacco Smoke Nicotine Dependence Behavioral: Ask, Advise, Refer Behavioral: Telebased tobacco counseling Behavioral: Telebased nutrition counseling Device: Mobile phone smoking cessation application Device: Mobile phone nutrition application Drug: Nicotine polacrilex Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 372 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multilevel Tobacco Intervention in Community Clinics for Underserved Families
Study Start Date : February 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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

Device: Mobile phone smoking cessation application
Smartphone based application to support smoking cessation efforts

Drug: Nicotine polacrilex
Over the counter nicotine replacement therapy in gum or lozenge form.
Other Name: nicotine gum, nicotine lozenge

Active Comparator: 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
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 nutrition counseling
Telephone counseling to promote nutritious eating practices in the family.

Device: Mobile phone nutrition application
Smartphone based application to support healthy eating habits




Primary Outcome Measures :
  1. Child urine cotinine [ Time Frame: up to 12 months ]
    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.

  2. Parent-reported secondhand smoke exposure in cigarettes per day [ Time Frame: up to 12 months ]
    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.


Secondary Outcome Measures :
  1. Parent-reported cotinine-verified 7-day point prevalence abstinence [ Time Frame: 7 days prior to 12 week and 12 month assessments ]
    When a participant reports smoking abstinence, the investigators will bioverify their smoking status.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602288


Contacts
Contact: Stephen J Lepore, PHD 215-204-9422 slepore@temple.edu
Contact: Melissa Godfrey, MPH 215-204-0315 melissa.godfrey@temple.edu

Locations
United States, Pennsylvania
Temple University Not yet recruiting
Philadelphia, Pennsylvania, United States, 19122
Contact: Melissa Godfrey, MPH    215-204-0315    melissa.godfrey@temple.edu   
Principal Investigator: Stephen J Lepore, PhD         
Principal Investigator: Bradley Collins, PhD         
N.O.R.T.H., Inc. Recruiting
Philadelphia, Pennsylvania, United States, 19132
Contact: Linda Kilby, PhD    215-978-6100 ext 13    lkilby@northwic.org   
Sub-Investigator: Linda Kilby, PhD         
Sponsors and Collaborators
Temple University
N.O.R.T.H., Inc.
Investigators
Principal Investigator: Stephen J Lepore, PhD Temple University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT02602288     History of Changes
Other Study ID Numbers: R01CA188813 ( U.S. NIH Grant/Contract )
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action