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Smoking Cessation Intervention in Public Housing

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ClinicalTrials.gov Identifier: NCT01035151
Recruitment Status : Unknown
Verified December 2009 by Medical University of South Carolina.
Recruitment status was:  Enrolling by invitation
First Posted : December 18, 2009
Last Update Posted : December 18, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

The major aim of this study is to test the effectiveness of a bundled, multi-level intervention (Sister to Sister) on smoking cessation outcomes in female smokers residing in public housing neighborhoods.

Hypothesis 1.1: As compared to the control group, women receiving the Sister to Sister Intervention will have higher 7-day point prevalence quit rates at 6- and 12-months as validated by salivary cotinine.

Hypothesis 1.2: As compared to the control group, women receiving the Sister to Sister Intervention will have higher 6- and 12-month prolonged smoking abstinence as validated by salivary cotinine.


Condition or disease Intervention/treatment
Cigarette Smoking Behavioral: Sister to Sister Behavioral: Control

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Social Ecological Based Smoking Cessation Intervention in Public Housing Neighborhoods
Study Start Date : July 2009
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Bundled Intervention Behavioral: Sister to Sister
Neighborhood level interventions, peer group (counseling, NRT), and individual level (Coach/CHW)
Experimental: Delayed Control Behavioral: Control
Written Cessation Materials


Outcome Measures

Primary Outcome Measures :
  1. smoking abstinence [ Time Frame: 6 and 12 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 yrs of age and older,
  • female, resident of public housing, daily smoker

Exclusion Criteria:

  • pregnant,
  • breastfeeding,
  • no intentions to quit smoking
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01035151


Locations
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30901
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jeannette Andrews, PhD Medical University of South Carolina
More Information

Responsible Party: Jeannette O. Andrews PhD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01035151     History of Changes
Other Study ID Numbers: MUS08022834
R01HL090951 ( U.S. NIH Grant/Contract )
First Posted: December 18, 2009    Key Record Dates
Last Update Posted: December 18, 2009
Last Verified: December 2009

Keywords provided by Medical University of South Carolina:
randomized cluster design
tobacco cessation
smoking cessation
African American