Smoking CessationNCT02492633
Prospective Evaluation of a Comprehensive Smoke-Free Public Housing Policy in a Multi-State Setting
A study testing Intervention in people with Smoking Cessation, run by Harvard School of Public Health (HSPH).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Have another household member enrolled in the study
About this study
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Control, Intervention
- Keywords
- Smoking cessation, Smoke-free housing, Affordable housing, Second-hand smoke, Tobacco control
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
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.
InterventionBehavioural
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:
- A web-based smoking cessation intervention via Facebook
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | The Standard Intervention will be offered to residents at all of Beacon Communities properties, regardless of the presence of this study. Receives: Behavioral: Control |
| Enhanced | Experimental | 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. Receives: Behavioral: Control; Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cigarettes smoked in the home
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.
Measured: 12 months
Secondary outcomes (2)
Air quality
Indoor air quality will be measured using airborne nicotine concentration (ug/m3) at the 12-month follow up assessment, compared with pre-baseline level.
Measured: 12 months
Change in motivation to quit smoking
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vaughan Rees, Harvard School of Public Health (HSPH)
- Investigators
- Vaughan Rees, PhD, Principal investigator, Harvard TH Chan School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492633
- Sponsor's protocol ID
- MAHHU0025-14
- Status last verified
- Aug 2017
- First submitted
- 6 Jul 2015
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a Comprehensive Smoke-Free Public Housing Policy in a Multi-State Setting
- ClinicalTrials.gov ID
- NCT02492633
- Acronym / sponsor ID
- MAHHU0025-14
- Conditions
- Smoking Cessation
- Keywords
- Smoking cessation, Smoke-free housing, Affordable housing, Second-hand smoke, Tobacco control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Boston University, Johns Hopkins Bloomberg School of Public Health
- Study start
- Jun 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Behavioral: ControlThe Standard Intervention will be offered to residents at all of Beacon Communities properties, regardless of the presence of this study. |
| Enhanced | Experimental | Behavioral: Control, Behavioral: InterventionAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Have smoked cigarettes or e-cigarettes in the last week
Key exclusion criteria (1 listed)
- Have another household member enrolled in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlThe 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. | Behavioural | Enhanced, Standard |
| InterventionAt 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. | Behavioural | Enhanced |
Primary outcome
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.
2 secondary outcomes
Air quality
Time frame: 12 months
Change in motivation to quit smoking
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vaughan Rees, PhD principal investigator
Harvard TH Chan School of Public Health
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Smoking Cessation, run by Harvard School of Public Health (HSPH).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cigarettes smoked in the home (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.