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

March 11, 2016 updated by: Patricia Dolan Mullen, The University of Texas Health Science Center, Houston

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

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

508

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 27, 2014

Study Record Updates

Last Update Posted (Estimate)

March 14, 2016

Last Update Submitted That Met QC Criteria

March 11, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

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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