Clinical trial NCT03476837: Reducing Tobacco Exposures Among African American Women and Children
Official title: Reducing Tobacco Exposures Among African American Socially Disadvantaged Children and Women Caregivers in the AR Delta Region
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Second Hand Tobacco Smoke
Keywords: secondhand smoke, African Americans, policies, tobacco use
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Coalition for a Tobacco Free Arkansas
name: Tri-County Rural Health Network
First posted: 2018-03-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comprehensive smokefree policy implementation
timeFrame: 12 months, rolling admissions
Secondary outcomes:
measure: Smoking abstinence
timeFrame: 1, 3, 6,12 months
measure: Smoking reduction
timeFrame: 1, 3, 6,12 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Pebbles Fagan, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.3390/ijerph182010877.