Smoking Cessation Intervention in Public Housing

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01035151
First received: December 17, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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 Intervention
Cigarette Smoking
Behavioral: Sister to Sister
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Social Ecological Based Smoking Cessation Intervention in Public Housing Neighborhoods

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • smoking abstinence [ Time Frame: 6 and 12 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 420
Study Start Date: July 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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: 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
Investigators
Principal Investigator: Jeannette Andrews, PhD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Jeannette O. Andrews PhD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01035151     History of Changes
Other Study ID Numbers: MUS08022834, R01HL090951
Study First Received: December 17, 2009
Last Updated: December 17, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 29, 2014