Reducing Tobacco Exposures Among African American Women and Children (FRESH)

University of Arkansas

Status: Completed

Conditions: Second Hand Tobacco Smoke; Tobacco Use

Treatments: Behavioral: Treatment; Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03476837

207306

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Behavioral Treatment

Experimental group

Description:

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.

Treatment:

Behavioral: Treatment

Control

Active Comparator group

Description:

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

Treatment:

Behavioral: Control