Reducing Tobacco Exposures Among African American Women and Children

NCT ID: NCT03476837

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2023-06-30

Brief 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. 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.

Conditions

Tobacco Use; Second Hand Tobacco Smoke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Behavioral Treatment

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.

Group Type: EXPERIMENTAL

Treatment

Intervention Type: BEHAVIORAL

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.

Control

WCGs will receive educational materials in the mail at 1, 3, and 6 months.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: BEHAVIORAL

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.

Interventions

Treatment

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.

Intervention Type: BEHAVIORAL

Control

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• 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

Exclusion Criteria

• Women outside of intervention counties

• Child who uses any form of tobacco
• Does not live in the home of the WCG

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Coalition for a Tobacco Free Arkansas

UNKNOWN

Sponsor Role: collaborator

Tri-County Rural Health Network

UNKNOWN

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pebbles Fagan, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 36370892 (View on PubMed)

Jones 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.

Reference Type: RESULT

PMID: 34682623 (View on PubMed)

Jones 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.

Reference Type: DERIVED

PMID: 40795917 (View on PubMed)

Clawson 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. 2024 Sep 30:10.1037/hea0001418. doi: 10.1037/hea0001418. Online ahead of print.

Reference Type: DERIVED

PMID: 39347763 (View on PubMed)

Other Identifiers

207306

Identifier Type: -

Identifier Source: org_study_id