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Completed

NCT Number: NCT01035151

Smoking Cessation Intervention in Public Housing

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Georgia, Augusta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • pregnant,
  • breastfeeding,
  • no intentions to quit smoking

Treatment and study plan

Experimental

Behavioral

Neighborhood level interventions, peer group (counseling, NRT), and individual level (Coach/CHW)

Control

Behavioral

Written Cessation Materials

Primary outcomes

  1. Number of Participants Abstinent From Smoking

    Time frame: 12 month

    Reported abstinence validated by exhaled CO and saliva cotinine

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Social Ecological Based Smoking Cessation Intervention in Public Housing Neighborhoods

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Dec 18, 2009
Registry last updated
Dec 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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