Prospective Evaluation of a Comprehensive Smoke-Free Public Housing Policy in a Multi-State Setting

December 5, 2017 updated by: Vaughan Rees, Harvard School of Public Health (HSPH)
The primary objective of this project is to evaluate the effectiveness of an enhanced intervention vs. a standard intervention to complement a comprehensive smoke-free policy, in a multi-site, privately managed affordable housing context.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Beacon Communities, a private property management company, is unveiling a comprehensive smoking ban at all 52 of its properties. A multi-component, "enhanced" intervention designed to promote, strengthen, and maintain a smoke-free policy across public housing developments will be implemented prior to commencement of the smoke-free policy. The enhanced intervention will be tested against a standard intervention of educational materials and information on cessation options. This study will be open to residents at 12 Beacon Communities properties at which a Resident Service Coordinator (RSC) is located.

The primary objective of this project is to evaluate the effectiveness of enhanced intervention vs. standard intervention to support a comprehensive smoke-free policy, in a multi-site, privately managed affordable housing context. A further objective is to develop a toolkit of strategies for the large-scale implementation and maintenance of a smoke-free policy in multi-unit affordable housing developments. The toolkit will be the first to be developed directly from an extensive two-stage qualitative analysis and will apply the lessons learned in this study to provide a sustainable resource for property managers seeking to implement smoke-free policies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
238

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 and over
  • Able to speak English or Spanish
  • A resident of Beacon Communities housing development (12 selected sites)
  • Thinks that he/she will be living in his/her Beacon Community for at least the next 12 months

For Smokers:

  • Have smoked cigarettes or e-cigarettes in the last week

For Non-Smokers:

  • Self-reported exposure to secondhand smoke in the previous 2 months

Exclusion Criteria:

  • Have another household member enrolled in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard
The Standard Intervention will be offered to residents at all of Beacon Communities properties, regardless of the presence of this study.
Behavioral: Control
The Standard Intervention will be offered to residents at all of Beacon Communities properties, regardless of the presence of this study. The standard intervention will be implemented as part of the smoke-free initiative roll out and will consist of: monthly articles in newsletters, re-usable shopping bag giveaways touting cessation messages, information provided via the property websites, and training of Residential Service Coordinators (RSCs) using the 8-session smoking cessation group training provided by the American Lung Association. The RSCs will offer group cessation counseling sessions for residents who would like support to quit smoking.
Experimental: Enhanced
At a subset of 6 Beacon Communities properties, residents will receive an 'enhanced intervention' in addition to the 'standard intervention' that Beacon Communities is already providing.
Behavioral: Control
The Standard Intervention will be offered to residents at all of Beacon Communities properties, regardless of the presence of this study. The standard intervention will be implemented as part of the smoke-free initiative roll out and will consist of: monthly articles in newsletters, re-usable shopping bag giveaways touting cessation messages, information provided via the property websites, and training of Residential Service Coordinators (RSCs) using the 8-session smoking cessation group training provided by the American Lung Association. The RSCs will offer group cessation counseling sessions for residents who would like support to quit smoking.
Behavioral: Intervention

At a subset of 6 Beacon Communities properties, residents will receive an 'enhanced intervention' in addition to the 'standard intervention' that Beacon Communities is already providing. The enhanced intervention will consist of the following:

  1. A web-based smoking cessation intervention via Facebook
  2. Enhanced gain-framed messaging communicated via several channels. Gain framed messages will incorporate themes of smoking cessation and policies which aim to distinguish from the vast 'library' of traditional messages which focus on loss-framing.
  3. A behavioral "nudge" designed to enhance public support for the smoke free policy, through personal adoption and adherence to the policy. This will be done by promoting a publicly viewable "pledge" program.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in cigarettes smoked in the home
Time Frame: 12 months
Cigarettes smoked in the home (defined as self-reported number of cigarettes smoked in the home in past 30 days) at the 12-month follow up assessment, compared with pre-baseline level.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Air quality
Time Frame: 12 months
Indoor air quality will be measured using airborne nicotine concentration (ug/m3) at the 12-month follow up assessment, compared with pre-baseline level.
12 months
Change in motivation to quit smoking
Time Frame: 12 months
Motivation to quit smoking (assessed by self-report on the 12-month follow up assessment), at 12 month follow-up, compared with pre-baseline level.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harvard School of Public Health (HSPH)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston University
Johns Hopkins Bloomberg School of Public Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vaughan Rees, PhD, Harvard TH Chan School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MAHHU0025-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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