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Completed

NCT Number: NCT02602288

Babies Living Safe and Smokefree

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

N.O.R.T.H., Inc., Philadelphia, Pennsylvania, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Telebased tobacco counseling

Behavioral

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

Telebased nutrition counseling

Behavioral

Telephone counseling to promote nutritious eating practices in the family.

Mobile phone smoking cessation application

Device

Smartphone based application to support smoking cessation efforts

Mobile phone nutrition application

Device

Smartphone based application to support healthy eating habits

Nicotine polacrilex

Drug

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

Other names: nicotine gum, nicotine lozenge

Primary outcomes

  1. Child Urine Cotinine

    Time frame: 3 months and 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. Cotinine values were log transformed to normalize distributions.

  2. Cigarettes/Day

    Time frame: 3 months and 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 outcomes

  1. Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence

    Time frame: 7 days prior to 3 month and 12 month assessments

    When a participant reports smoking abstinence, the investigators will bioverify their smoking status.

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • N.O.R.T.H., Inc.

Registry information

Official study title

Multilevel Tobacco Intervention in Community Clinics for Underserved Families

Acronym: BLiSS

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 11, 2015
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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