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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02097914
Other study ID # HSC-SPH-13-0902
Secondary ID U10CA154282-03
Status Completed
Phase N/A
First received March 24, 2014
Last updated March 11, 2016
Start date March 2014
Est. completion date November 2015

Study information

Verified date March 2016
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority USA: NIH/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 systematically test an intervention designed to create smoke-free homes in low income households among 2-1-1 callers. During this randomized control trial, researchers will disseminate and evaluate a brief smoke-free homes intervention through the established infrastructure of a Texas 2-1-1 call center. 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 main hypothesis to be tested is that a higher proportion of households in the intervention group will establish and maintain a smoke-free home than in the measures-only control group.


Recruitment information / eligibility

Status Completed
Enrollment 508
Est. completion date November 2015
Est. primary completion date January 2015
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:

- Participants who are in immediate crisis

- Participants who are calling to be transferred to the TIERS program

- Participants who are homeless or facing homelessness

Study Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
Educational print materials and 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 University of Texas School of Public Health Houston Texas

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

References & Publications (2)

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, 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 smoked (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 Cessation (for smokers) Change from baseline in cessation (for smokers) at 3-month and 6-month follow-up No
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