Clinical trial NCT02097914: Brief Interventions to Create Smoke-Free Home Policies in Low-Income Households: Texas Effectiveness Trial
Official title: Brief Interventions to Create Smoke-Free Home Policies in Low-Income Households: Texas Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: Secondhand smoke exposure
Secondhand smoke
Environmental Tobacco Smoke
Smoke-free homes
Smoke-free homes ban
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Emory University
name: University of North Carolina, Chapel Hill
name: Washington University School of Medicine
First posted: 2014-03-27
Enrollment: 508
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Presence of a total home smoking ban
timeFrame: Change from baseline in reported total home smoking bans at 3-month and 6-month follow-up
Secondary outcomes:
measure: Weekly secondhand smoke exposure for non-smokers
timeFrame: Change from baseline in reported secondhand smoke exposure for non-smokers at 3-month and 6-month follow-up
measure: Cessation attempts (for smokers)
timeFrame: Change from baseline in reported cessation attempts (for smokers) at 3-month and 6-month follow-up
measure: Number of cigarettes smoked (for smokers)
timeFrame: Change from baseline in reported number of cigarettes smoked (for smokers) at 3-month and 6-month follow-up
measure: Stage of change to quit smoking (for smokers)
timeFrame: Change from baseline in stage of change to quit smoking (for smokers) at 3-month and 6-month follow-up
measure: Cessation (for smokers)
timeFrame: Change from baseline in cessation (for smokers) at 3-month and 6-month follow-up
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas School of Public Health
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Patricia D Mullen, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Maria E Fernandez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Lara Savas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Jo Ann A Gutierrez, MPH
role: STUDY_DIRECTOR
References:
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.
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.
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.