Reducing Tobacco Exposures Among African American Women and Children

Tobacco Use Clinical Trial

— FRESH  

Official title:

Reducing Tobacco Exposures Among African American Socially Disadvantaged Children and Women Caregivers in the AR Delta Region

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03476837
• Other study ID #: 207306
• Status: Completed
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Second Hand Tobacco Smoke
• Tobacco Use

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (3)

Lead Sponsor	Collaborator
University of Arkansas	Coalition for a Tobacco Free Arkansas, Tri-County Rural Health Network

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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")	12 months, rolling admissions
Secondary	Smoking abstinence	We will measure 7-day point prevalence abstinence	1, 3, 6,12 months
Secondary	Smoking reduction	We will measures number of cigarettes smoked per day	1, 3, 6,12 months