Tobacco UseFRESHNCT03476837
Reducing Tobacco Exposures Among African American Women and Children
A study testing Treatment in people with Tobacco Use and Second Hand Tobacco Smoke, run by University of Arkansas at 1 site in United States.
Trial summary
Secondhand smoke exposure in the home can causes sudden infant death syndrome (SIDS), asthma, respiratory illnesses, and ear infections in children. In addition to cigarette smoke, exposure to other tobacco products can further compromise the safety of children in the home. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Second Hand Tobacco Smoke
- What is being tested?
- Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Woman Caregiver Inclusion Criteria:
- African American women caregivers
- Aged 18-50
- Primary caregivers of at least one child in the home aged 6 months-14 (birth parent, guardian)
- Primary decision-maker in the AR home
- English speaking
- Can provide written informed consent
- Working phone and home address
- Smoked cigarettes and/or cigars for at least 1 year
- Low income as defined by any indicator (e.g., Medicaid; Earned Income Tax Credit; Children's Health Insurance Plan [ARKids]; subsidized housing; child care subsidies; food stamps; low-income energy assistance; free/reduced lunch program; supplemental nutrition program; Head Start program)
Woman Caregiver Exclusion Criteria:
- Women outside of intervention counties
Child Inclusion Criteria: (No longer enrolling the child bc of COVID19 and inability to collect saliva)
- Live in the home with African American WCG who is the legal parent or guardian enrolled in study
- Aged 6 months to 14 years
- Non-tobacco user
Child Exclusion Criteria:
- Child who uses any form of tobacco
- Does not live in the home of the WCG
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Reducing Tobacco Exposures Among African American Socially Disadvantaged Children and Women Caregivers in the AR Delta Region
Secondhand smoke exposure in the home can causes sudden infant death syndrome (SIDS), asthma, respiratory illnesses, and ear infections in children. In addition to cigarette smoke, exposure to other tobacco products can further compromise the safety of children in the home. This study aims to reduce the burden of multiple tobacco exposures, improve access to preventive care, and reduce the disproportionate risk for chronic diseases, including cancer, among African American women and children living in the Arkansas Delta region. Our central hypothesis is that messages delivered by a community health worker that aim to modify knowledge, attitudes, beliefs, and subjective norms may influence the perceived threat of tobacco exposures and provide cues for African American women caregivers to implement comprehensive smokefree policies to protect their children from the harms of tobacco and in-turn, influence their quitting.
Read the detailed description
Cigarette smoking among African American women in Arkansas is nearly double the prevalence for African American women in the United States. Historical trends show increasing lung cancer mortality among African American Arkansan women. Further, secondhand (SHS) exposure is highest among African Americans and persons living in poverty. Declines in SHS exposure are much slower among these groups than their comparative groups. Smokefree policies in the home can reduce SHS exposure and increase quit attempts. To date, few trials have investigated how to increase the adoption and implementation of evidence-based strategies to reduce SHS exposure in the homes of women caregivers in rural disadvantaged communities. Our study will develop and test the feasibility and efficacy of brief motivational counseling and risk-communication messages delivered by community health workers (CHWs) on the implementation of comprehensive smokefree policies (e.g. ban on cigarettes, cigars, e-cigarettes, and safekeeping of tobacco products from children) in the home. The specific aims are to 1) conduct semi-structured interviews among African American women caregivers (WCGs) and CHWs to understand risk perceptions, knowledge, attitudes, beliefs, and safety practices related to tobacco products and sociocultural and environmental influences on tobacco use and policy practices; 2) use the interview data to develop, adapt, and pilot test educational materials, motivational counseling, and tobacco exposure feedback using an iterative process of six focus groups of WCGs; and 3) assess the influence of the intervention on the primary outcome, implementation of comprehensive smokefree policies, and secondary outcomes, 7-day point prevalence abstinence and smoking reduction. H3:1 Compared to WCGs in the control group (n = 103), WCGs in the intervention group will be more likely to implement CS policies (n = 103); H3:2. will have higher 7-day point prevalence abstinence and smoke fewer cigarettes per day at 1, 3, 6, and 12 months; and H3:3. their attitudes will mediate the effects of tobacco exposure biofeedback on the outcomes. The data from this study could 1) greatly enhance the adoption of voluntary comprehensive smokefree policies in a state where the strength of state-level tobacco control policies is low and 2) reduce the risk for smoking-attributable mortality, including cancer, among socially disadvantaged women and children.
- Conditions
- Tobacco Use, Second Hand Tobacco Smoke
- Being tested
- Treatment, Control
- Keywords
- secondhand smoke, African Americans, policies, tobacco use
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentBehavioural
The CHWs will go to the homes of the WCGs who enroll in the study and will use a culturally-adapted motivational interviewing protocol, educational messages pilot tested during the formative research phase, and biofeedback based on the child's saliva sample and WCG's carbon monoxide. Saliva samples will be collect from one child in the home at baseline and final. Baseline saliva data and carbon monoxide monitoring will be used to develop feedback that aims to motivate WCGs to implement and sustain comprehensive smoke free policies. The intervention will last 6 months. We will measure changes in primary and secondary outcomes at multiple assessment points.
ControlBehavioural
Following baseline assessment, at 1, 3, and 6 months, WCGs in the control group will educational materials in the mail. Final follow-up assessments will occur at 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Treatment | Experimental | Following baseline, the CHWs will deliver three doses of the intervention to the treatment (intervention) group over a 6-month period with follow-up at 12 months for all WCGs. At 1, 3, and 6 months, WCGs will receive motivational interviewing, educational materials and biofeedback based on the child's saliva sample and WCG's carbon monoxide. Receives: Behavioral: Treatment |
| Control | Active comparator | WCGs will receive educational materials in the mail at 1, 3, and 6 months. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive smokefree policy implementation
We will measure and compare comprehensive smoke free policy implementation in the intervention and control groups, adapting standard measures from the Tobacco Use Supplement to the Current Population Survey (i.e. "Which statement best describes rules about smoking in your home? (1) no one is allowed to smoke anywhere inside your home; (2) smoking is allowed in some places or at some time inside your home; (3) smoking is permitted anywhere inside your home")
Measured: 12 months, rolling admissions
Secondary outcomes (2)
Smoking abstinence
We will measure 7-day point prevalence abstinence
Measured: 1, 3, 6,12 months
Smoking reduction
We will measures number of cigarettes smoked per day
Measured: 1, 3, 6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start15 Jan 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two groups based on the baseline assessment of CS policy (no policy/partial policy). WCGs in the treatment group will receive a three-session dose at 1, 3, and 6 months. During each treatment group session, the CHW will provide the tobacco biofeedback, motivational interviewing and educational materials at the end of the session. WCGs in the control group will receive by mail the same series of educational materials received by the treatment group at 1, 3 and 6 months. Survey and other assessments will be collected at baseline, 1, 3, 6, and 12 months.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Coalition for a Tobacco Free Arkansas, Tri-County Rural Health Network
- Responsible party
- Sponsor
- Investigators
- Pebbles Fagan, PhD, MPH, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476837
- Sponsor's protocol ID
- 207306
- Acronym
- FRESH
- Status last verified
- Oct 2023
- First submitted
- 28 Feb 2018
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jones DM, Bullock S, Donald K, Cooper S, Miller W, Davis AH, Cottoms N, Orloff M, Bryant-Moore K, Guy MC, Fagan P. Factors associated with smokefree rules in the homes of Black/African American women smokers residing in low-resource rural communities. Prev Med. 2022 Dec;165(Pt B):107340. doi: 10.1016/j.ypmed.2022.107340. Epub 2022 Nov 10.
PubMed 36370892Jones DM, Clawson AH, Jin J, Bullock S, Donald K, Cooper S, Miller W, Huff Davis A, Orloff M, Bryant-Moore K, Hasan A, Guy MC, Fagan P. Evidence-based practices are effective in increasing smoke-free home rules among Black women who smoke. J Natl Cancer Inst Monogr. 2025 Aug 1;2025(70):224-234. doi: 10.1093/jncimonographs/lgaf026.
PubMed 40795917Clawson AH, Jones DM, Jin J, Du R, Bullock S, Donald K, Orloff M, Miller W, Cooper S, Fagan P. Caregiver restrictions on child access to tobacco in the home and home Smoking/Vaping bans among Black/African American women caregivers who smoke and live in Resource-limited, rural areas. Prev Med Rep. 2024 Oct 28;48:102918. doi: 10.1016/j.pmedr.2024.102918. eCollection 2024 Dec.
PubMed 39534461Clawson AH, Jones DM, Bullock S, Donald K, Cottoms N, Orloff M, Fagan P. Home environment and cigarette quitting behaviors among rural Black/African American women caregivers. Health Psychol. 2025 Jan;44(1):66-79. doi: 10.1037/hea0001418. Epub 2024 Sep 30.
PubMed 39347763Jones DM, Kulik MC, Baezconde-Garbanati L, Bullock S, Guy MC, Fagan P. Menthol Smoking and Nicotine Dependence among Black/African American Women Smokers Living in Low-Resource, Rural Communities. Int J Environ Res Public Health. 2021 Oct 16;18(20):10877. doi: 10.3390/ijerph182010877.
PubMed 34682623
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Tobacco Exposures Among African American Socially Disadvantaged Children and Women Caregivers in the AR Delta Region
- ClinicalTrials.gov ID
- NCT03476837
- Acronym / sponsor ID
- FRESH / 207306
- Conditions
- Tobacco Use, Second Hand Tobacco Smoke
- Keywords
- secondhand smoke, African Americans, policies, tobacco use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Coalition for a Tobacco Free Arkansas, Tri-County Rural Health Network
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Secondhand smoke exposure in the home can causes sudden infant death syndrome (SIDS), asthma, respiratory illnesses, and ear infections in children. In addition to cigarette smoke, exposure to other tobacco products can further compromise the safety of children in the home. This study aims to reduce the burden of multiple tobacco exposures, improve access to preventive care, and reduce the disproportionate risk for chronic diseases, including cancer, among African American women and children living in the Arkansas Delta region. Our central hypothesis is that messages delivered by a community health worker that aim to modify knowledge, attitudes, beliefs, and subjective norms may influence the perceived threat of tobacco exposures and provide cues for African American women caregivers to implement comprehensive smokefree policies to protect their children from the harms of tobacco and in-turn, influence their quitting.
Detailed description
Cigarette smoking among African American women in Arkansas is nearly double the prevalence for African American women in the United States. Historical trends show increasing lung cancer mortality among African American Arkansan women. Further, secondhand (SHS) exposure is highest among African Americans and persons living in poverty. Declines in SHS exposure are much slower among these groups than their comparative groups. Smokefree policies in the home can reduce SHS exposure and increase quit attempts. To date, few trials have investigated how to increase the adoption and implementation of evidence-based strategies to reduce SHS exposure in the homes of women caregivers in rural disadvantaged communities. Our study will develop and test the feasibility and efficacy of brief motivational counseling and risk-communication messages delivered by community health workers (CHWs) on the implementation of comprehensive smokefree policies (e.g. ban on cigarettes, cigars, e-cigarettes, and safekeeping of tobacco products from children) in the home. The specific aims are to 1) conduct semi-structured interviews among African American women caregivers (WCGs) and CHWs to understand risk perceptions, knowledge, attitudes, beliefs, and safety practices related to tobacco products and sociocultural and environmental influences on tobacco use and policy practices; 2) use the interview data to develop, adapt, and pilot test educational materials, motivational counseling, and tobacco exposure feedback using an iterative process of six focus groups of WCGs; and 3) assess the influence of the intervention on the primary outcome, implementation of comprehensive smokefree policies, and secondary outcomes, 7-day point prevalence abstinence and smoking reduction. H3:1 Compared to WCGs in the control group (n = 103), WCGs in the intervention group will be more likely to implement CS policies (n = 103); H3:2. will have higher 7-day point prevalence abstinence and smoke fewer cigarettes per day at 1, 3, 6, and 12 months; and H3:3. their attitudes will mediate the effects of tobacco exposure biofeedback on the outcomes. The data from this study could 1) greatly enhance the adoption of voluntary comprehensive smokefree policies in a state where the strength of state-level tobacco control policies is low and 2) reduce the risk for smoking-attributable mortality, including cancer, among socially disadvantaged women and children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Participants will be randomized into two groups based on the baseline assessment of CS policy (no policy/partial policy). WCGs in the treatment group will receive a three-session dose at 1, 3, and 6 months. During each treatment group session, the CHW will provide the tobacco biofeedback, motivational interviewing and educational materials at the end of the session. WCGs in the control group will receive by mail the same series of educational materials received by the treatment group at 1, 3 and 6 months. Survey and other assessments will be collected at baseline, 1, 3, 6, and 12 months.
| Arm | Type | Receives |
|---|---|---|
| Behavioral Treatment | Experimental | Behavioral: TreatmentFollowing baseline, the CHWs will deliver three doses of the intervention to the treatment (intervention) group over a 6-month period with follow-up at 12 months for all WCGs. At 1, 3, and 6 months, WCGs will receive motivational interviewing, educational materials and biofeedback based on the child's saliva sample and WCG's carbon monoxide. |
| Control | Active comparator | Behavioral: ControlWCGs will receive educational materials in the mail at 1, 3, and 6 months. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| TreatmentThe CHWs will go to the homes of the WCGs who enroll in the study and will use a culturally-adapted motivational interviewing protocol, educational messages pilot tested during the formative research phase, and biofeedback based on the child's saliva sample and WCG's carbon monoxide. Saliva samples will be collect from one child in the home at baseline and final. Baseline saliva data and carbon monoxide monitoring will be used to develop feedback that aims to motivate WCGs to implement and sustain comprehensive smoke free policies. The intervention will last 6 months. We will measure changes in primary and secondary outcomes at multiple assessment points. | Behavioural | Behavioral Treatment |
| ControlFollowing baseline assessment, at 1, 3, and 6 months, WCGs in the control group will educational materials in the mail. Final follow-up assessments will occur at 12 months. | Behavioural | Control |
Primary outcome
Comprehensive smokefree policy implementation
Time frame: 12 months, rolling admissions
We will measure and compare comprehensive smoke free policy implementation in the intervention and control groups, adapting standard measures from the Tobacco Use Supplement to the Current Population Survey (i.e. "Which statement best describes rules about smoking in your home? (1) no one is allowed to smoke anywhere inside your home; (2) smoking is allowed in some places or at some time inside your home; (3) smoking is permitted anywhere inside your home")
2 secondary outcomes
Smoking abstinence
Time frame: 1, 3, 6,12 months
Smoking reduction
Time frame: 1, 3, 6,12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 36370892Jones DM, Bullock S, Donald K, Cooper S, Miller W, Davis AH, Cottoms N, Orloff M, Bryant-Moore K, Guy MC, Fagan P. Factors associated with smokefree rules in the homes of Black/African American women smokers residing in low-resource rural communities. Prev Med. 2022 Dec;165(Pt B):107340. doi: 10.1016/j.ypmed.2022.107340. Epub 2022 Nov 10.
- Background: PubMed 40795917Jones DM, Clawson AH, Jin J, Bullock S, Donald K, Cooper S, Miller W, Huff Davis A, Orloff M, Bryant-Moore K, Hasan A, Guy MC, Fagan P. Evidence-based practices are effective in increasing smoke-free home rules among Black women who smoke. J Natl Cancer Inst Monogr. 2025 Aug 1;2025(70):224-234. doi: 10.1093/jncimonographs/lgaf026.
- Background: PubMed 39534461Clawson AH, Jones DM, Jin J, Du R, Bullock S, Donald K, Orloff M, Miller W, Cooper S, Fagan P. Caregiver restrictions on child access to tobacco in the home and home Smoking/Vaping bans among Black/African American women caregivers who smoke and live in Resource-limited, rural areas. Prev Med Rep. 2024 Oct 28;48:102918. doi: 10.1016/j.pmedr.2024.102918. eCollection 2024 Dec.
- Background: PubMed 39347763Clawson AH, Jones DM, Bullock S, Donald K, Cottoms N, Orloff M, Fagan P. Home environment and cigarette quitting behaviors among rural Black/African American women caregivers. Health Psychol. 2025 Jan;44(1):66-79. doi: 10.1037/hea0001418. Epub 2024 Sep 30.
- Results publication: PubMed 34682623Jones DM, Kulik MC, Baezconde-Garbanati L, Bullock S, Guy MC, Fagan P. Menthol Smoking and Nicotine Dependence among Black/African American Women Smokers Living in Low-Resource, Rural Communities. Int J Environ Res Public Health. 2021 Oct 16;18(20):10877. doi: 10.3390/ijerph182010877.
- Individual participant dataSharing planned: No
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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.
Pebbles Fagan, PhD, MPH principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment in people with Tobacco Use and Second Hand Tobacco Smoke, run by University of Arkansas at 1 site 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?
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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comprehensive smokefree policy implementation (time frame: 12 months, rolling admissions). 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 NCT03476837, which also lists 5 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 8 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.