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临床试验/NCT05016505
NCT05016505已完成不适用

A Randomized Controlled Trial to Support Smoke-Free Policy Compliance in Public Housing

Columbia University1 个研究点 分布在 1 个国家目标入组 405 人开始时间: 2022年2月3日最近更新:
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
405
试验地点
1
主要终点
Change in number of cigarettes smoked per day

研究概览

简要总结

This project seeks to determine the effectiveness of two types of interventions to reduce exposure to secondhand smoke in residential buildings. One intervention is geared toward all building residents (resident endorsement) and the other targets smokers (smoking reduction via relocation and reduction in personal smoking/cessation) with the goal of reducing personal smoking and secondhand smoke exposure.

详细描述

Smoke-free housing policies in multi-unit housing are promising and increasingly widespread interventions to reduce smoking and secondhand smoke exposure. Little research has identified factors that improve compliance with smoke-free housing policies in low-income multi-unit housing and test corresponding solutions.

The proposed randomized controlled trial (RCT) addresses key gaps in knowledge and capitalizes on key scientific opportunities by: 1) leveraging the federal mandate to ban smoking in a public housing system of more than sufficient size to conduct an adequately powered RCT; 2) expanding our understanding of smoke-free policy compliance beyond policy implementation by testing two novel treatments: a) in-residence smoking cessation and b) resident endorsement, while 3) addressing population and location-specific tobacco-related disparities.

The investigators hypothesize that the relocation/cessation plus resident endorsement intervention will yield significantly larger reductions in personal smoking and secondhand smoke exposure, compared to standalone interventions and the standard approach.

研究设计

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

入排标准

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

入选标准

  • Building Inclusion Criteria:
  • NYCHA buildings in Manhattan & the Bronx (stratified evenly by borough) with more than 50 units, not undergoing major renovations.

排除标准

  • Buildings in a borough that is not in Manhattan or the Bronx
  • Buildings smaller than 50 units
  • Buildings undergoing major renovations
  • Buildings that are or will be part of Rental Assistance Demonstration (RAD) or Permanent Affordability Commitment Together (PACT)
  • Buildings that are mixed finance
  • Buildings that are exclusively for elderly
  • Buildings that are privately managed
  • Buildings that have other research studies ongoing
  • Participant Inclusion Criteria:
  • Recruit NYCHA residents via door knocking and lobby intercepts until we reach our targeted number per group (4 smokers, 4 non-smokers in each building).
  • Residents will be screened for smoking status. Both smokers and non-smokers to be recruited but only one participant- smoker or a non-smoker- will be recruited per apartment.
  • Smoking will be defined as those that report using a cigarette or other combustible tobacco product (e.g., little cigar, cigarillo) at least 5 days in the past month. Non-smokers include never smokers and former smokers who had quit 12 months ago or earlier.
  • Additional eligibility criteria include individuals above 18 years old living in the building at least 5 days/week and 9 months/year, not planning on moving in the next 2 years.
  • Participant Exclusion Criteria:
  • Individuals with severe physical or mental medical conditions (i.e. cognitive disability) or other factors that could limit participation or ability to give informed consent in the study at baseline or during follow-ups.
  • Individuals who participated in the earlier focus groups.
  • Individuals who only smoke non-tobacco products (e.g., marijuana).

研究组 & 干预措施

Compliance through reduction (relocation and reduction of personal smoking) and cessation

Experimental

Smokers will be referred by the survey team to peer educators from a community-based organization trained to provide peer to peer health education including tobacco cessation support. The peer educator will coordinate smoking cessation support, including serving as a liaison between participant and research team, providing information regarding the smoke-free policy and opportunities for relocation, and connecting participant to access to tobacco replacement therapy and/or physician support if deemed appropriate.

干预措施: Reduction (relocation and reduction of personal smoking) and cessation (Behavioral)

Compliance through resident endorsement

Experimental

Buildings assigned will be targeted for a series of 2 in-residence programs that involve community forums and the creative arts to garner resident endorsements of smoke-free living environments. Premised on resident engagement, this arm seeks to impact social and physical dimensions of the residential environment to achieve compliance. The sessions will: 1) inform residents of risks associated with smoking and secondhand smoke; 2) identify reasons to have a smoke-free home, 3) ask residents to sign a pledge on paper and/or virtually; 4) display smoke-free signage on doors and/or social media pages with an original hashtag (#Smokefree[building address]); and 5) refer residents to the Smoke-free NYCHA website for information on the policy and existing cessation resources.

干预措施: Resident Endorsement (Behavioral)

Compliance through reduction/cessation plus resident endorsement (combined)

Experimental

The combined intervention will be carried out in the buildings assigned to this RCT arm, which will provide in-residence programs based on the resident endorsement treatment and the smoking relocation/cessation treatment. Both will occur simultaneously with one geared toward all building residents (resident endorsement) and the other targeting smokers (smoking relocation/cessation) with the goal of reducing both personal smoking and secondhand smoke exposure.

干预措施: Reduction (relocation and reduction of personal smoking) and cessation (Behavioral)

Compliance through reduction/cessation plus resident endorsement (combined)

Experimental

The combined intervention will be carried out in the buildings assigned to this RCT arm, which will provide in-residence programs based on the resident endorsement treatment and the smoking relocation/cessation treatment. Both will occur simultaneously with one geared toward all building residents (resident endorsement) and the other targeting smokers (smoking relocation/cessation) with the goal of reducing both personal smoking and secondhand smoke exposure.

干预措施: Resident Endorsement (Behavioral)

Standard NYCHA approach (control)

No Intervention

Buildings and study participants assigned to this arm will be recruited and followed over a 12-month period to assess outcomes. No additional programs or services will be delivered to the buildings or residents assigned to this arm beyond standard programs that NYCHA may provide to support the smoke-free mandate. Field staff will document any policy-related signage, activities or information to which these participants are exposed.

结局指标

主要结局

Change in number of cigarettes smoked per day

时间窗: Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)

Self-reported average number of cigarettes smoked per day among smokers

Change in salivary cotinine

时间窗: At baseline and at the 12-month follow-up

Salivary cotinine (saliva collected as passive drool) will be measured for 25% of the sample among smokers and non-smokers alike

Change in secondhand smoke exposure

时间窗: Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)

Self-reported secondhand smoking exposure (hours of secondhand smoke exposure in the building in the past 7 days); among smokers \& non-smokers

次要结局

  • Change in number of hours of secondhand smoke exposure(Number of hours observed someone smoking indoors within the past 7 days measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview))
  • Change in number of quit attempts(Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview))
  • Change in number of participants with secondhand smoke observations(Ever observing someone smoking indoors within the past 7 days measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview))
  • Change in number of participants with successful quit attempts(Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview))
  • Change in number of smokers(At each building visit at baseline and 12 months)
  • Change in number of cigarette butts(At each building visit at baseline and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Diana Hernandez, PhD

Associate Professor of Sociomedical Sciences

Columbia University

研究点 (1)

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