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临床试验/NCT01035151
NCT01035151已完成不适用

Social Ecological Based Smoking Cessation Intervention in Public Housing Neighborhoods

Medical University of South Carolina4 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2009年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
420
试验地点
4
主要终点
Number of Participants Abstinent From Smoking

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Delayed Control

Active Comparator

Women in the delayed control condition received culturally sensitive smoking cessation written materials at week 1, and mailed materials at week 6, 12, and 18. At the end of the study (i.e., after the 12 month data collection), participants were offered counseling, nicotine patches, and community health worker contacts.

干预措施: Control (Behavioral)

Experimental

Experimental

Women in neighborhoods randomized to the S2S received 24-week bundled multi-level intervention. Individual-led strategies were led by paid community health workers (CHWs). The CHWs provided 1:1 contact to reinforce social support, and enhanced self-efficacy with cessation attempts. A certified smoking cessation counselor led behavioral group sessions using the S2S handbook based on the PHS Guidelines. The weekly group sessions were initiated during the 1st week of the intervention, with a total of 6 group sessions over a 6-week period. Transdermal nicotine patches were offered to participants who set a quit date. Within the 24-week study period, the neighborhood tenant association, in partnership with study staff, implemented at least two neighborhood level anti-smoking activities

干预措施: Experimental (Behavioral)

结局指标

主要结局

Number of Participants Abstinent From Smoking

时间窗: 12 month

Reported abstinence validated by exhaled CO and saliva cotinine

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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