Smoking CessationNCT04657250
mHealth for Smoking Cessation in Public Housing
A study testing Smoking cessation + quitline linkage text messages and Passive quitline referral in people with Smoking Cessation, run by George Washington University at 1 site in United States.
Trial summary
Smoking rates among public housing residents are more than twice as high as in the general population. In August 2018, the U.S. Department of Housing and Urban Development (HUD) required all public housing in the U.S. to become smoke-free. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Smoking cessation + quitline linkage text messages and Passive quitline referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2020to 31 Jul 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- resident of D.C. public housing
- smoked a cigarette in the 7 days prior to screening (self-report)
- has daily access to a working cell phone with an unlimited text message plan
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University
Washington D.C., District of Columbia, 20052
About this study
Smoking rates among public housing residents are more than twice as high as in the general population. In August 2018, the U.S. Department of Housing and Urban Development (HUD) required all public housing in the U.S. to become smoke-free. While HUD recommended that Public Housing Authorities provide smoking cessations services, at present, the D.C. Housing Authority (DCHA) does not offer any cessation services to its residents. Low-income smokers face unique challenges to smoking cessation and require sustained support for smoking cessation. Digital interventions such as text messaging programs and quitline (QL) phone counseling are scalable, evidence-based interventions for smoking cessation that can provide support over an extended timeframe at low cost.
The aim of this proposed research is to conduct a feasibility trial to assess the acceptability, levels of engagement, and preliminary efficacy of an integrated program that combines text-messaging for smoking cessation and text messages providing proactive linkage to the quitline compared to a single passive quitline text message referral among DCHA residents. The investigators hypothesize that the integrated program (combining text messages for smoking cessation and proactive quitline linkage) will yield significantly higher rates of quit attempts than passive quitline referral only.
- Conditions
- Smoking Cessation
- Being tested
- Smoking cessation + quitline linkage text messages, Passive quitline referral
- Keywords
- mobile phone, mHealth, text messaging
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation + quitline linkage text messagesBehavioural
Smoking cessation text messages will provide behavioral skills and support for quitting smoking. Quitline linkage text messages will include contact information for the quitline, option to be contacted by the quitline and active referral to the quitline upon setting a Quit Date.
Passive quitline referralBehavioural
Single text message with contact information for the Quitline
| Study group | Role | What they receive |
|---|---|---|
| Smoking cessation + quitline linkage text messages | Experimental | Text messaging for smoking cessation + text messages with proactive linkage to quitline Receives: Behavioral: Smoking cessation + quitline linkage text messages |
| Passive quitline referral | Placebo comparator | Single text message with contact information for the Quitline Receives: Behavioral: Passive quitline referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants making a quit attempt
not smoking for 24 hours or more because trying to quit smoking
Measured: 3 months
Secondary outcomes (2)
Proportion of participants who quit smoking
self reported 7 day point prevalence abstinence
Measured: 3 months
Number of cigarettes smoked per day
change in number of cigarettes smoked per day between baseline and follow-up
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start26 Oct 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Why it stopped: COVID-19
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.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorien Abroms, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657250
- Sponsor's protocol ID
- NCR191457
- Status last verified
- Nov 2022
- First submitted
- 1 Dec 2020
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth for Smoking Cessation in Public Housing
- ClinicalTrials.gov ID
- NCT04657250
- Acronym / sponsor ID
- NCR191457
- Conditions
- Smoking Cessation
- Keywords
- mobile phone, mHealth, text messaging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 8 Dec 2020 (actual)
- 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.
Smoking rates among public housing residents are more than twice as high as in the general population. In August 2018, the U.S. Department of Housing and Urban Development (HUD) required all public housing in the U.S. to become smoke-free. While HUD recommended that Public Housing Authorities provide smoking cessations services, at present, the D.C. Housing Authority (DCHA) does not offer any cessation services to its residents. Low-income smokers face unique challenges to smoking cessation and require sustained support for smoking cessation. Digital interventions such as text messaging programs and quitline (QL) phone counseling are scalable, evidence-based interventions for smoking cessation that can provide support over an extended timeframe at low cost.
The aim of this proposed research is to conduct a feasibility trial to assess the acceptability, levels of engagement, and preliminary efficacy of an integrated program that combines text-messaging for smoking cessation and text messages providing proactive linkage to the quitline compared to a single passive quitline text message referral among DCHA residents. The investigators hypothesize that the integrated program (combining text messages for smoking cessation and proactive quitline linkage) will yield significantly higher rates of quit attempts than passive quitline referral only.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking cessation + quitline linkage text messages | Experimental | Behavioral: Smoking cessation + quitline linkage text messagesText messaging for smoking cessation + text messages with proactive linkage to quitline |
| Passive quitline referral | Placebo comparator | Behavioral: Passive quitline referralSingle text message with contact information for the Quitline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- resident of D.C. public housing
- smoked a cigarette in the 7 days prior to screening (self-report)
- has daily access to a working cell phone with an unlimited text message plan
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Smoking cessation + quitline linkage text messagesSmoking cessation text messages will provide behavioral skills and support for quitting smoking. Quitline linkage text messages will include contact information for the quitline, option to be contacted by the quitline and active referral to the quitline upon setting a Quit Date. | Behavioural | Smoking cessation + quitline linkage text messages |
| Passive quitline referralSingle text message with contact information for the Quitline | Behavioural | Passive quitline referral |
Primary outcome
Proportion of participants making a quit attempt
Time frame: 3 months
not smoking for 24 hours or more because trying to quit smoking
2 secondary outcomes
Proportion of participants who quit smoking
Time frame: 3 months
Number of cigarettes smoked per day
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation + quitline linkage text messages and Passive quitline referral in people with Smoking Cessation, run by George Washington University at 1 site in United States.
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 4 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: withdrawn, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Proportion of participants making a quit attempt (time frame: 3 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 8 Nov 2022.