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Brief Interventions to Create Smoke-Free Home Policies in Low-Income Households: Texas Effectiveness Trial (SFH)

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ClinicalTrials.gov Identifier: NCT02097914
Recruitment Status : Completed
First Posted : March 27, 2014
Last Update Posted : March 14, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Emory University
University of North Carolina, Chapel Hill
Washington University School of Medicine
Information provided by (Responsible Party):
Patricia Dolan Mullen, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE March 24, 2014
First Posted Date  ICMJE March 27, 2014
Last Update Posted Date March 14, 2016
Study Start Date  ICMJE March 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02097914 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2014)
  • 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 ]
  • Cessation attempts (for smokers) [ Time Frame: 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 ]
  • 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 ]
  • Cessation (for smokers) [ Time Frame: Change from baseline in cessation (for smokers) at 3-month and 6-month follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brief Interventions to Create Smoke-Free Home Policies in Low-Income Households: Texas Effectiveness Trial
Official Title  ICMJE Brief Interventions to Create Smoke-Free Home Policies in Low-Income Households: Texas Effectiveness Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Disease
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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: Behavioral: Educational print materials and coaching call
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2016)
508
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2014)
550
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02097914
Other Study ID Numbers  ICMJE HSC-SPH-13-0902
U10CA154282-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Patricia Dolan Mullen, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Emory University
  • University of North Carolina, Chapel Hill
  • Washington University School of Medicine
Investigators  ICMJE
Principal Investigator: Patricia D Mullen, DrPH The University of Texas Health Science Center, Houston
Principal Investigator: Maria E Fernandez, PhD 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
PRS Account The University of Texas Health Science Center, Houston
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP