Brief Interventions to Create Smoke-Free Home Policies in Low-Income Households: Texas Effectiveness Trial (SFH)
Primary Purpose
Chronic Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational print materials and coaching call
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Disease focused on measuring Secondhand smoke exposure, Secondhand smoke, Environmental Tobacco Smoke, Smoke-free homes, Smoke-free homes ban
Eligibility Criteria
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
Sites / Locations
- University of Texas School of Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
Participant receives usual care.
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.
Outcomes
Primary Outcome Measures
Presence of a total home smoking ban
Secondary Outcome Measures
Weekly secondhand smoke exposure for non-smokers
Cessation attempts (for smokers)
Number of cigarettes smoked (for smokers)
Stage of change to quit smoking (for smokers)
Cessation (for smokers)
Full Information
NCT ID
NCT02097914
First Posted
March 24, 2014
Last Updated
March 11, 2016
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Cancer Institute (NCI), Emory University, University of North Carolina, Chapel Hill, Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02097914
Brief Title
Brief Interventions to Create Smoke-Free Home Policies in Low-Income Households: Texas Effectiveness Trial
Acronym
SFH
Official Title
Brief Interventions to Create Smoke-Free Home Policies in Low-Income Households: Texas Effectiveness Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Cancer Institute (NCI), Emory University, University of North Carolina, Chapel Hill, Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Secondhand smoke exposure, Secondhand smoke, Environmental Tobacco Smoke, Smoke-free homes, Smoke-free homes ban
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
508 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participant receives usual care.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Educational print materials and coaching call
Intervention Description
Intervention group participants receive three sets of mailed educational materials about making their home smoke-free and one coaching call.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Cessation attempts (for smokers)
Time Frame
Change from baseline in reported cessation attempts (for smokers) at 3-month and 6-month follow-up
Title
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
Title
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
Title
Cessation (for smokers)
Time Frame
Change from baseline in cessation (for smokers) at 3-month and 6-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia D Mullen, DrPH
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria E Fernandez, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lara Savas, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jo Ann A Gutierrez, MPH
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Study Director
Facility Information:
Facility Name
University of Texas School of Public Health
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22675374
Citation
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.
Results Reference
background
PubMed Identifier
23669213
Citation
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.
Results Reference
background
PubMed Identifier
27697943
Citation
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.
Results Reference
derived
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Brief Interventions to Create Smoke-Free Home Policies in Low-Income Households: Texas Effectiveness Trial
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