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

Primary Purpose

Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational print materials and coaching call
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Disease focused on measuring Secondhand smoke exposure, Smoke-free homes, Smoke-free home bans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of North Carolina, Chapel Hill

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 one 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)
Successful cessation (for smokers)

Full Information

First Posted
May 30, 2013
Last Updated
August 1, 2014
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Cancer Institute (NCI), Emory University, The University of Texas Health Science Center, Houston, Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01868672
Brief Title
Brief Intervention to Create Smoke-Free Homes Policies in Low-Income Households: North Carolina Effectiveness Trial
Official Title
Brief Intervention to Create Smoke-Free Homes Policies in Low-Income Households: North Carolina Effectiveness Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Cancer Institute (NCI), Emory University, The University of Texas Health Science Center, Houston, 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 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.

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, Smoke-free homes, Smoke-free home bans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
500 (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 one 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 fro 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
Successful cessation (for smokers)
Time Frame
Change from baseline in successful 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: All participants who are not in immediate crisis will be invited to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca S Williams, MHS, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina, Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
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

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

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