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Clinical Trials/NCT01035151
NCT01035151
Completed
Not Applicable

Social Ecological Based Smoking Cessation Intervention in Public Housing Neighborhoods

Medical University of South Carolina2 sites in 1 country420 target enrollmentJuly 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cigarette Smoking
Sponsor
Medical University of South Carolina
Enrollment
420
Locations
2
Primary Endpoint
Number of Participants Abstinent From Smoking
Status
Completed
Last Updated
7 years ago

Overview

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.

Detailed Description

This was a cluster randomized controlled study evaluating the effect of a multi-level intervention, Sister to Sister, on the smoking cessation in two Southeastern US metropolitan areas. Fourteen subsidized housing neighborhoods, eight in Charleston, SC and six in Augusta, GA, were pair matched based on size; with one neighborhood in each pair randomized to the intervention to ensure balanced recruitment between groups. Neighborhoods ranged in size from 22 to 33 participants with a total sample size of 409 women; neighborhoods were chosen as the primary sampling unit to prevent contamination of the outcome within neighborhoods, with women in the neighborhoods as secondary sampling unit. All statistical analyses were conducted using SAS 9.2 (SAS Institute, Cary, NC) with statistical significance at an alpha level of 0.05. Comparison between groups at baseline used t-tests for continuous variables and chi-square tests for categorical variables. The primary outcome of interest was smoking status which was dichotomized (smoker/non-smoker) at the 6 and 12 month measurements. Smoking status was determined by cotinine levels in saliva with non-smokers defined as those with cotinine levels of 14 ng/mL or less.

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
May 15, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Number of Participants Abstinent From Smoking

Time Frame: 12 month

Reported abstinence validated by exhaled CO and saliva cotinine

Study Sites (2)

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