Second Hand Tobacco SmokeBLiSSNCT02602288
Babies Living Safe and Smokefree
A study testing Ask, Advise, Refer, Telebased tobacco counseling and Telebased nutrition counseling in people with Second Hand Tobacco Smoke and Nicotine Dependence, run by Temple University at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Second Hand Tobacco Smoke, Nicotine Dependence
- What is being tested?
- Ask, Advise, Refer, Telebased tobacco counseling and Telebased nutrition counseling
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2016to 23 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- non-nicotine drug dependence
- active psychiatric disturbance (bipolar, schizophrenia, psychosis)
- inadequate health literacy
- pregnant
- no smartphone
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Temple University
Philadelphia, Pennsylvania, 19122
N.O.R.T.H., Inc.
Philadelphia, Pennsylvania, 19132
About this study
Official title: 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 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
- Being tested
- Ask, Advise, Refer, Telebased tobacco counseling, Telebased nutrition counseling, Mobile phone smoking cessation application, Mobile phone nutrition application
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ask, Advise, ReferBehavioural
WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources
Telebased tobacco counselingBehavioural
Telephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke
Telebased nutrition counselingBehavioural
Telephone counseling to promote nutritious eating practices in the family.
Mobile phone smoking cessation applicationDevice
Smartphone based application to support smoking cessation efforts
Mobile phone nutrition applicationDevice
Smartphone based application to support healthy eating habits
Nicotine polacrilexDrug
Also called nicotine gum, nicotine lozenge
Over the counter nicotine replacement therapy in gum or lozenge form.
| Study group | Role | What they receive |
|---|---|---|
| AAR+Behavioral Intervention (EXP) | Experimental | 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. Receives: Behavioral: Ask, Advise, Refer; Behavioral: Telebased tobacco counseling; Device: Mobile phone smoking cessation application; Drug: Nicotine polacrilex |
| AAR+Attention Control Intervention (CTL) | Active comparator | 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 Receives: Behavioral: Ask, Advise, Refer; Behavioral: Telebased nutrition counseling; Device: Mobile phone nutrition application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Urine Cotinine
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.
Measured: 3 months and 12 months
Cigarettes/Day
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.
Measured: 3 months and 12 months
Secondary outcomes (1)
Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence
When a participant reports smoking abstinence, the investigators will bioverify their smoking status.
Measured: 7 days prior to 3 month and 12 month assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startFeb 2016
- Primary completion23 Oct 2019
- Study completion23 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Second Hand Tobacco SmokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- N.O.R.T.H., Inc.
- Responsible party
- Sponsor
- Investigators
- Stephen J Lepore, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602288
- Sponsor's protocol ID
- R01CA188813
- Acronym
- BLiSS
- Status last verified
- Feb 2022
- First submitted
- 9 Nov 2015
- Last updated
- 15 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Collins BN, Lepore SJ, Egleston BL. Eliminating children's tobacco smoke exposure: a pathway to bioverified abstinence among low-income maternal smokers in the Babies Living Safe and Smokefree (BLiSS) trial. J Behav Med. 2023 Dec;46(6):1042-1048. doi: 10.1007/s10865-023-00423-9. Epub 2023 Jun 7.
PubMed 37285107Collins 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.
PubMed 35196033Lepore 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.
PubMed 34255698Collins 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.
PubMed 28288601
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multilevel Tobacco Intervention in Community Clinics for Underserved Families
- ClinicalTrials.gov ID
- NCT02602288
- Acronym / sponsor ID
- BLiSS / R01CA188813
- Conditions
- Second Hand Tobacco Smoke, Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- N.O.R.T.H., Inc.
- Study start
- Feb 2016
- Primary completion
- 23 Oct 2019 (actual)
- Study completion
- 23 Oct 2019 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Posted 15 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AAR+Behavioral Intervention (EXP) | Experimental | Behavioral: Ask, Advise, Refer, Behavioral: Telebased tobacco counseling, Device: Mobile phone smoking cessation application, Drug: Nicotine polacrilexAsk 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. |
| AAR+Attention Control Intervention (CTL) | Active comparator | Behavioral: Ask, Advise, Refer, Behavioral: Telebased nutrition counseling, Device: Mobile phone nutrition applicationAsk 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- non-nicotine drug dependence
- active psychiatric disturbance (bipolar, schizophrenia, psychosis)
- inadequate health literacy
- pregnant
- no smartphone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ask, Advise, ReferWIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources | Behavioural | AAR+Attention Control Intervention (CTL), AAR+Behavioral Intervention (EXP) |
| Telebased tobacco counselingTelephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke | Behavioural | AAR+Behavioral Intervention (EXP) |
| Telebased nutrition counselingTelephone counseling to promote nutritious eating practices in the family. | Behavioural | AAR+Attention Control Intervention (CTL) |
| Mobile phone smoking cessation applicationSmartphone based application to support smoking cessation efforts | Device | AAR+Behavioral Intervention (EXP) |
| Mobile phone nutrition applicationSmartphone based application to support healthy eating habits | Device | AAR+Attention Control Intervention (CTL) |
| Nicotine polacrilexAlso: nicotine gum, nicotine lozengeOver the counter nicotine replacement therapy in gum or lozenge form. | Drug | AAR+Behavioral Intervention (EXP) |
Primary outcome
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.
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.
1 secondary outcome
Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence
Time frame: 7 days prior to 3 month and 12 month assessments
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37285107Collins BN, Lepore SJ, Egleston BL. Eliminating children's tobacco smoke exposure: a pathway to bioverified abstinence among low-income maternal smokers in the Babies Living Safe and Smokefree (BLiSS) trial. J Behav Med. 2023 Dec;46(6):1042-1048. doi: 10.1007/s10865-023-00423-9. Epub 2023 Jun 7.
- Derived from this study: PubMed 35196033Collins 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.
- Derived from this study: PubMed 34255698Lepore 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.
- Derived from this study: PubMed 28288601Collins 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.
- Individual participant dataSharing planned: No
Related trials for Second Hand Tobacco Smoke
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J Lepore, PhD principal investigator
Temple University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ask, Advise, Refer, Telebased tobacco counseling and Telebased nutrition counseling in people with Second Hand Tobacco Smoke and Nicotine Dependence, run by Temple University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Urine Cotinine (time frame: 3 months and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02602288, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.