NCT02097914

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
508

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

March 14, 2016

Status Verified

March 1, 2016

Enrollment Period

10 months

First QC Date

March 24, 2014

Last Update Submit

March 11, 2016

Conditions

Keywords

Secondhand smoke exposureSecondhand smokeEnvironmental Tobacco SmokeSmoke-free homesSmoke-free homes ban

Outcome Measures

Primary Outcomes (1)

  • Presence of a total home smoking ban

    Change from baseline in reported total home smoking bans at 3-month and 6-month follow-up

Secondary Outcomes (5)

  • Weekly secondhand smoke exposure for non-smokers

    Change from baseline in reported secondhand smoke exposure for non-smokers at 3-month and 6-month follow-up

  • Cessation attempts (for smokers)

    Change from baseline in reported cessation attempts (for smokers) at 3-month and 6-month follow-up

  • Number of cigarettes smoked (for smokers)

    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)

    Change from baseline in stage of change to quit smoking (for smokers) at 3-month and 6-month follow-up

  • Cessation (for smokers)

    Change from baseline in cessation (for smokers) at 3-month and 6-month follow-up

Study Arms (2)

Control

NO INTERVENTION

Participant receives usual care.

Intervention

EXPERIMENTAL

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.

Behavioral: Educational print materials and coaching call

Interventions

Intervention group participants receive three sets of mailed educational materials about making their home smoke-free and one coaching call.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants who are in immediate crisis
  • Participants who are calling to be transferred to the TIERS program
  • Participants who are homeless or facing homelessness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas School of Public Health

Houston, Texas, 77030, United States

Location

Related Publications (3)

  • 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.

    PMID: 22675374BACKGROUND
  • 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.

    PMID: 23669213BACKGROUND
  • 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.

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
  • Jo Ann A Gutierrez, MPH

    The University of Texas Health Science Center, Houston

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor - Health Prom & Behavioral Sci - SPH

Study Record Dates

First Submitted

March 24, 2014

First Posted

March 27, 2014

Study Start

March 1, 2014

Primary Completion

January 1, 2015

Study Completion

November 1, 2015

Last Updated

March 14, 2016

Record last verified: 2016-03

Locations