Reducing Tobacco Exposures Among African American Women and Children

NCT03476837 | Completed DMC

• 1 other identifier: 207306
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use; Second Hand Tobacco Smoke

Keywords

secondhand smoke, African Americans, policies, tobacco use

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Smoking abstinence

  1, 3, 6,12 months

• Smoking reduction

  1, 3, 6,12 months

Study Arms (2)

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.

Behavioral: Treatment

Control

ACTIVE COMPARATOR

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

Behavioral: Control

Interventions

Treatment 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.

Behavioral Treatment

Control 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.

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: The caregiver must be female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Women outside of intervention counties
• 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 who uses any form of tobacco
• Does not live in the home of the WCG

Sponsors & Collaborators

• University of Arkansas: lead
• Coalition for a Tobacco Free Arkansas: collaborator
• Tri-County Rural Health Network: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (4)

• 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.

  PMID: 36370892 BACKGROUND

• 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.

  PMID: 34682623 RESULT

• 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.

  PMID: 40795917 DERIVED

• 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. 2025 Jan;44(1):66-79. doi: 10.1037/hea0001418. Epub 2024 Sep 30.

  PMID: 39347763 DERIVED

MeSH Terms

Conditions

Tobacco Use

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Pebbles Fagan, PhD, MPH

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The recruiter will not know the client allocation. The CHW will not know who the women are in the control group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 26, 2018
• Study Start: January 15, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)