- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02097914
Brief Interventions to Create Smoke-Free Home Policies in Low-Income Households: Texas Effectiveness Trial (SFH)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas School of Public Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Participant receives usual care.
|
|
Experimental: Intervention
Educational print materials and coaching call: Intervention group participants receive three sets of mailed educational materials about making their home smoke-free and once coaching call.
|
Intervention group participants receive three sets of mailed educational materials about making their home smoke-free and one coaching call.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Presence of a total home smoking ban
Time Frame: Change from baseline in reported total home smoking bans at 3-month and 6-month follow-up
|
Change from baseline in reported total home smoking bans at 3-month and 6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weekly secondhand smoke exposure for non-smokers
Time Frame: Change from baseline in reported secondhand smoke exposure for non-smokers at 3-month and 6-month follow-up
|
Change from baseline in reported secondhand smoke exposure for non-smokers at 3-month and 6-month follow-up
|
Cessation attempts (for smokers)
Time Frame: Change from baseline in reported cessation attempts (for smokers) at 3-month and 6-month follow-up
|
Change from baseline in reported cessation attempts (for smokers) at 3-month and 6-month follow-up
|
Number of cigarettes smoked (for smokers)
Time Frame: Change from baseline in reported number of cigarettes smoked (for smokers) at 3-month and 6-month follow-up
|
Change from baseline in reported number of cigarettes smoked (for smokers) at 3-month and 6-month follow-up
|
Stage of change to quit smoking (for smokers)
Time Frame: Change from baseline in stage of change to quit smoking (for smokers) at 3-month and 6-month follow-up
|
Change from baseline in stage of change to quit smoking (for smokers) at 3-month and 6-month follow-up
|
Cessation (for smokers)
Time Frame: Change from baseline in cessation (for smokers) at 3-month and 6-month follow-up
|
Change from baseline in cessation (for smokers) at 3-month and 6-month follow-up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Maria E Fernandez, PhD, The University of Texas Health Science Center, Houston
- Principal Investigator: Patricia D Mullen, DrPH, The University of Texas Health Science Center, Houston
- Principal Investigator: Lara Savas, PhD, The University of Texas Health Science Center, Houston
- Study Director: Jo Ann A Gutierrez, MPH, The University of Texas Health Science Center, Houston
Publications and helpful links
General Publications
- Kegler MC, Escoffery C, Bundy L, Berg CJ, Haardorfer 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.
- Escoffery C, Bundy L, Carvalho M, Yembra D, Haardorfer 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.
- Mullen PD, Savas LS, Bundy LT, Haardorfer R, Hovell M, Fernandez ME, Monroy JA, Williams RS, Kreuter MW, Jobe D, Kegler MC. Minimal intervention delivered by 2-1-1 information and referral specialists promotes smoke-free homes among 2-1-1 callers: a Texas generalisation trial. Tob Control. 2016 Oct;25(Suppl 1):i10-i18. doi: 10.1136/tobaccocontrol-2016-053045.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-SPH-13-0902
- U10CA154282-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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