Brief Intervention to Create Smoke-Free Homes Policies in Low-Income Households: North Carolina Effectiveness Trial

This study has been completed.
Sponsor:
Collaborators:
Emory University
The University of Texas Health Science Center, Houston
Washington University School of Medicine
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01868672
First received: May 30, 2013
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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 North Carolina 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.


Condition Intervention
Chronic Disease
Behavioral: Educational print materials and coaching call

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brief Intervention to Create Smoke-Free Homes Policies in Low-Income Households: North Carolina Effectiveness Trial

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weekly secondhand smoke exposure for non-smokers [ Time Frame: Change from baseline in reported secondhand smoke exposure fro non-smokers at 3-month and 6-month follow-up ] [ Designated as safety issue: No ]
  • Cessation attempts (for smokers) [ Time Frame: Change from baseline in reported cessation attempts (for smokers) at 3-month and 6-month follow-up ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Successful cessation (for smokers) [ Time Frame: Change from baseline in successful cessation (for smokers) at 3-month and 6-month follow-up ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: June 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 one coaching call.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

  • All participants who are not in immediate crisis will be invited to participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01868672

Locations
United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Emory University
The University of Texas Health Science Center, Houston
Washington University School of Medicine
Investigators
Principal Investigator: Rebecca S Williams, MHS, PhD University of North Carolina, Chapel Hill
  More Information

Publications:
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01868672     History of Changes
Other Study ID Numbers: 13-1808, U01CA154282
Study First Received: May 30, 2013
Last Updated: August 1, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
Secondhand smoke exposure
Smoke-free homes
Smoke-free home bans

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014