Brief Interventions to Create Smoke-Free Home Policies in Low-Income Households

Chronic Diseases Clinical Trial

Official title:

Brief Interventions to Create Smoke-Free Home Policies in Low-Income Households

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625468
• Other study ID #: IRB00056797
• Secondary ID: U01CA154282-01
• Status: Completed
• Phase: N/A
• First received: May 31, 2012
• Last updated: March 7, 2015
• Start date: June 2012
• Est. completion date: July 2013

Study information

• Verified date: March 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Office for Human Research ProtectionsUnited States: Emory Institutional Review BoardUnited States: Emory Office of Research ComplianceUnited States: National Cancer Institute
• Study type: Interventional

Clinical Trial Summary

The burden of tobacco use falls disproportionately on low-income populations, through high rates of primary smoking and exposure to secondhand smoke. The remarkable progress in creating smoke-free environments in the U.S. over the past two decades has left smoker's homes as one of the primary sources of exposure to secondhand smoke for both children and nonsmoking adults. Intervention research that identifies effective and practical strategies for reaching the minority of households that still allow smoking in the home has considerable potential to reduce smoke exposure, but suitable channels to reach low-income families are limited. The proposed research will develop, evaluate and disseminate a brief smoke-free homes intervention through the established national infrastructure of 2-1-1 call centers. 2-1-1 is a nationally designated 3-digit telephone exchange, similar to 9-1-1 for emergencies or 4-1-1 for directory assistance, that links callers to community-based health and social services.

The proposed research has four specific aims: 1) Conduct formative research on intervention messages and materials for promoting smoke-free homes in low-income populations, applicable to both smokers and nonsmokers as household change agents; 2) Conduct a randomized controlled trial in the Atlanta 2-1-1 service area to evaluate the efficacy of a brief intervention to create smoke-free homes among 2-1-1 callers; 3) Conduct replication studies in Houston and North Carolina 2-1-1 systems to systematically test the intervention in varied populations and tobacco control climates, and 4) Disseminate the research-tested smoke-free homes intervention through a variety of mechanisms including a national grants program to 2-1-1 systems and through the Tobacco Technical Assistance Consortium's linkages to the state and local tobacco control infrastructure in the U.S.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be 18 years of age or older.

• Must speak and understand English.

• Must smoke and live with at least one other non-smoking person OR be a non-smoker who lives with a smoker(s).

• Must not have a total smoking ban in their home.

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Diseases

Intervention

Behavioral:
• Educational print materials and a coaching call
Intervention group participants receive three sets of mailed educational materials about making their home smoke-free and one coaching call.

Locations

Country	Name	City	State
United States	Emory University Rollins School of Public Health	Atlanta	Georgia

Sponsors (5)

Lead Sponsor	Collaborator
Emory University	National Cancer Institute (NCI), The University of Texas Health Science Center, Houston, University of North Carolina, Chapel Hill, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (4)

Berg CJ, Bundy L, Escoffery C, Haardörfer R, Kegler MC. Telephone-assisted placement of air nicotine monitors to validate self-reported smoke-free home policies. Public Health. 2013 Apr;127(4):342-4. doi: 10.1016/j.puhe.2013.01.002. Epub 2013 Mar 6. — View Citation

Escoffery C, Bundy L, Carvalho M, Yembra D, Haardörfer R, Berg C, Kegler MC. Third-hand smoke as a potential intervention message for promoting smoke-free homes in low-income communities. Health Educ Res. 2013 Oct;28(5):923-30. doi: 10.1093/her/cyt056. Epub 2013 May 13. — View Citation

Kegler MC, Bundy L, Haardörfer R, Escoffery C, Berg C, Yembra D, Kreuter M, Hovell M, Williams R, Mullen PD, Ribisl K, Burnham D. A minimal intervention to promote smoke-free homes among 2-1-1 callers: a randomized controlled trial. Am J Public Health. 20 — View Citation

Kegler MC, Escoffery C, Bundy L, Berg CJ, Haardörfer R, Yembra D, Schauer G. Pilot study results from a brief intervention to create smoke-free homes. J Environ Public Health. 2012;2012:951426. doi: 10.1155/2012/951426. Epub 2012 May 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of a total home smoking ban		Change from baseline in reported total home smoking bans at 3-month and 6-month follow-up	No
Secondary	Weekly secondhand smoke exposure for non-smokers		Change from baseline in reported secondhand smoke exposure for non-smokers at 3-month and 6-month follow-up	No
Secondary	Cessation attempts (for smokers)		Change from baseline in reported cessation attempts (for smokers) at 3-month and 6-month follow-up	No
Secondary	Number of cigarettes smokes (for smokers)		Change from baseline in reported number of cigarettes smoked (for smokers) at 3-month and 6-month follow-up	No
Secondary	Stage of change to quit smoking (for smokers)		Change from baseline in stage of change to quit smoking (for smokers) at 3-month and 6-month follow-up	No
Secondary	Successful cessation (for smokers)		Change from baseline in successful cessation (for smokers) at 3-month and 6-month follow-up	No