Tobacco Use CessationSFHNCT04311983
Interventions to Help More Low-income Smokers Quit
A study testing Tobacco Quitline and Smoke Free Home in people with Tobacco Use Cessation and Smoking Behaviors, run by Washington University School of Medicine at 1 site in United States.
Trial summary
In a Hybrid Type 2 randomized trial, 1,980 low-income smokers from nine states with high smoking prevalence will be recruited from 2-1-1 helplines to receive either current standard practice (Quitline) or expanded services (Quitline + Smoke Free Homes) to increase tobacco cessation. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation, Smoking Behaviors, Health Disparity
- What is being tested?
- Tobacco Quitline and Smoke Free Home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,973 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2020to 29 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥21
- English-speaking
- Daily smoker
- Does not have a full home smoking ban
- Recruited from those who called 2-1-1 for themselves and are not in acute crisis
Who cannot join
- -Pregnant women, because recommended tobacco cessation actions differ for this subset of smokers
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Expanding Population-level Interventions to Help More Low-income Smokers Quit
In a Hybrid Type 2 randomized trial, 1,980 low-income smokers from nine states with high smoking prevalence will be recruited from 2-1-1 helplines to receive either current standard practice (Quitline) or expanded services (Quitline + Smoke Free Homes) to increase tobacco cessation.
Read the detailed description
There is an urgent need to engage more low-income smokers in activities that lead to quitting. The current standard of practice for population-level tobacco treatment is phone-based cessation counseling delivered by state tobacco quitlines. But quitline services are restricted to smokers who are ready to quit in the next 30 days, a criterion met by only 20-30% of low-income smokers. Thus, current population level tobacco treatment has nothing to offer 70-80% of low-income U.S. smokers. Based on extensive preliminary research by our study team, the investigators assert that offering a pre-cessation intervention - Smoke Free Homes - to low-income smokers who are not yet ready to quit will: (1) engage more smokers in using proven interventions; (2) increase their readiness to quit and quit attempts; (3) reduce the number of cigarettes they smoke per day; and (4) increase cessation. These benefits will accrue in addition to reducing exposure to harmful secondhand smoke for non-smokers in the home. In a Hybrid Type 2 randomized trial, 1,980 low-income smokers from nine states with high smoking prevalence will be recruited from 2-1-1 helplines to receive either current standard practice (Quitline) or expanded services (Quitline + Smoke Free Homes). In the latter condition, smokers will be offered cessation counseling first, just like current standard practice, but those who decline will then be offered Smoke Free Homes. At 3-month followup, those in the latter condition who accepted quitline services but did not quit will be offered Smoke Free Homes, and those that accepted Smoke Free Homes but did not quit will be offered quitline services. The effectiveness portion of the Hybrid Type 2 design (Aim 1) will use intent-to-treat analyses to compare group differences at 3- and 6-month follow-up in 7- and 30-day point prevalence abstinence with biochemical verification, as well as 24-hour quit attempts and cigarettes smoked per day. The implementation portion of the Hybrid Type 2 design (Aims 2-3) will measure smokers' acceptance and use of the interventions, as well as cost-effectiveness and cost-benefits of adding Smoke Free Homes to quitline services. With rates of smoking and smoking-related cancers much higher in low-income populations and treatment costs exceeding tens of billions of dollars annually in Medicaid alone, this large-scale practical trial will provide strong evidence with high external validity to answer an important policy question: Will changing the standard practice for population-level treatment of smoking result in increased cessation in low-income populations?
- Conditions
- Tobacco Use Cessation, Smoking Behaviors, Health Disparity
- Being tested
- Tobacco Quitline, Smoke Free Home
- Medical subject headings
- Tobacco Use Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco QuitlineBehavioural
Tobacco quitlines provide phone counseling from a quit coach, often supplemented with NRT (nicotine replacement therapy), a quit guide, text messages, or other support. Smokers can call directly or consent to be called by the quitline ("fax-back").
Smoke Free HomeBehavioural
The intervention guides participants though a 5-step process: (1) deciding to create a smoke-free home; (2) talking about it with household members; (3) setting a date for the home to become smoke-free; (4) making the home smoke-free; and (5) keeping the home smoke-free. Progress from one step to the next is facilitated over a 6-week period by three mailings sent to participants' homes and one telephone counseling call delivered by a trained smoke free homes coach.
| Study group | Role | What they receive |
|---|---|---|
| Tobacco Quitline only | Active comparator | Smokers in this study group will be offered their state Tobacco Quitline programs Receives: Behavioral: Tobacco Quitline |
| Tobacco Quitline plus Smoke Free Homes | Experimental | Smokers in this study group will be offered their state Tobacco Quitline programs, but if they decline, they will be offered a Smoke Free Homes intervention Receives: Behavioral: Tobacco Quitline; Behavioral: Smoke Free Home |
What is being measured
The primary outcome is the main question the study is designed to answer.
7day Point Prevalence for Smoking
Percentage of participants who have 7 day smoking abstinence
Measured: 6 month follow-up
Secondary outcomes (1)
Proportion of Participants Who Accept the Tobacco Quitline Program
- All participants are asked at baseline if they are interested in trying the <STATE> tobacco quitline. Some participants are asked this question again at the 3-month follow-up
- The probability is the proportion who answer "yes".
- Due to our study design, at 3-month follow-up, Tobacco Quitline plus Smoke Free Homes participants were only offered the Quitline if they had not chosen it at baseline. The proportion in the table is the number of participants who accepted the Quitline divided by number who were offered the Quitline.
Measured: Baseline and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start31 Mar 2020
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group intervention; standard care vs. standard + additional service
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,973 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Matthew Kreuter, Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311983
- Sponsor's protocol ID
- 202002125-1001
- Other IDs
- 1R01CA235773-01A1
- Acronym
- SFH
- Status last verified
- Oct 2024
- First submitted
- 10 Mar 2020
- Last updated
- 10 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The HCRL Data Center will make the datasets and other materials available without cost to researchers and analysts after a data sharing agreement is completed. Consistent with NIH guidelines, the data sharing agreement: (1) records a request for data use and detailed description of the intent of use; (2) details the study's publication guidelines, including acknowledging and citing project personnel as appropriate; (3) ensures IRB compliance, including not using these data for non-research purposes; and (4) stipulates that users will not share or distribute the data to others without written permission.
Publications
McQueen A, Wolff J, Grimes L, Teshome E, Garg R, Thompson T, Carpenter K, Kegler MC, Kreuter MW. Comparing acceptance of smoking cessation and smoke-free home intervention offers and associated factors among people with low income in the USA: baseline results of a randomised controlled trial. BMJ Public Health. 2024 Apr 22;2(1):e000843. doi: 10.1136/bmjph-2023-000843. eCollection 2024 Jun.
PubMed 40018164Wolff JM, McQueen A, Garg R, Thompson T, Fu Q, Brown DS, Kegler M, Carpenter KM, Kreuter MW. Expanding population-level interventions to help more low-income smokers quit: Study protocol for a randomized controlled trial. Contemp Clin Trials. 2023 Jun;129:107202. doi: 10.1016/j.cct.2023.107202. Epub 2023 Apr 18.
PubMed 37080354
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Population-level Interventions to Help More Low-income Smokers Quit
- ClinicalTrials.gov ID
- NCT04311983
- Acronym / sponsor ID
- SFH / 202002125-1001
- Conditions
- Tobacco Use Cessation, Smoking Behaviors, Health Disparity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,973 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Posted 10 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a Hybrid Type 2 randomized trial, 1,980 low-income smokers from nine states with high smoking prevalence will be recruited from 2-1-1 helplines to receive either current standard practice (Quitline) or expanded services (Quitline + Smoke Free Homes) to increase tobacco cessation.
Detailed description
There is an urgent need to engage more low-income smokers in activities that lead to quitting. The current standard of practice for population-level tobacco treatment is phone-based cessation counseling delivered by state tobacco quitlines. But quitline services are restricted to smokers who are ready to quit in the next 30 days, a criterion met by only 20-30% of low-income smokers. Thus, current population level tobacco treatment has nothing to offer 70-80% of low-income U.S. smokers. Based on extensive preliminary research by our study team, the investigators assert that offering a pre-cessation intervention - Smoke Free Homes - to low-income smokers who are not yet ready to quit will: (1) engage more smokers in using proven interventions; (2) increase their readiness to quit and quit attempts; (3) reduce the number of cigarettes they smoke per day; and (4) increase cessation. These benefits will accrue in addition to reducing exposure to harmful secondhand smoke for non-smokers in the home. In a Hybrid Type 2 randomized trial, 1,980 low-income smokers from nine states with high smoking prevalence will be recruited from 2-1-1 helplines to receive either current standard practice (Quitline) or expanded services (Quitline + Smoke Free Homes). In the latter condition, smokers will be offered cessation counseling first, just like current standard practice, but those who decline will then be offered Smoke Free Homes. At 3-month followup, those in the latter condition who accepted quitline services but did not quit will be offered Smoke Free Homes, and those that accepted Smoke Free Homes but did not quit will be offered quitline services. The effectiveness portion of the Hybrid Type 2 design (Aim 1) will use intent-to-treat analyses to compare group differences at 3- and 6-month follow-up in 7- and 30-day point prevalence abstinence with biochemical verification, as well as 24-hour quit attempts and cigarettes smoked per day. The implementation portion of the Hybrid Type 2 design (Aims 2-3) will measure smokers' acceptance and use of the interventions, as well as cost-effectiveness and cost-benefits of adding Smoke Free Homes to quitline services. With rates of smoking and smoking-related cancers much higher in low-income populations and treatment costs exceeding tens of billions of dollars annually in Medicaid alone, this large-scale practical trial will provide strong evidence with high external validity to answer an important policy question: Will changing the standard practice for population-level treatment of smoking result in increased cessation in low-income populations?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two group intervention; standard care vs. standard + additional service
| Arm | Type | Receives |
|---|---|---|
| Tobacco Quitline only | Active comparator | Behavioral: Tobacco QuitlineSmokers in this study group will be offered their state Tobacco Quitline programs |
| Tobacco Quitline plus Smoke Free Homes | Experimental | Behavioral: Tobacco Quitline, Behavioral: Smoke Free HomeSmokers in this study group will be offered their state Tobacco Quitline programs, but if they decline, they will be offered a Smoke Free Homes intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥21
- English-speaking
- Daily smoker
- Does not have a full home smoking ban
- Recruited from those who called 2-1-1 for themselves and are not in acute crisis
Key exclusion criteria (1 listed)
- -Pregnant women, because recommended tobacco cessation actions differ for this subset of smokers
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 |
|---|---|---|
| Tobacco QuitlineTobacco quitlines provide phone counseling from a quit coach, often supplemented with NRT (nicotine replacement therapy), a quit guide, text messages, or other support. Smokers can call directly or consent to be called by the quitline ("fax-back"). | Behavioural | Tobacco Quitline only, Tobacco Quitline plus Smoke Free Homes |
| Smoke Free HomeThe intervention guides participants though a 5-step process: (1) deciding to create a smoke-free home; (2) talking about it with household members; (3) setting a date for the home to become smoke-free; (4) making the home smoke-free; and (5) keeping the home smoke-free. Progress from one step to the next is facilitated over a 6-week period by three mailings sent to participants' homes and one telephone counseling call delivered by a trained smoke free homes coach. | Behavioural | Tobacco Quitline plus Smoke Free Homes |
Primary outcome
7day Point Prevalence for Smoking
Time frame: 6 month follow-up
Percentage of participants who have 7 day smoking abstinence
1 secondary outcome
Proportion of Participants Who Accept the Tobacco Quitline Program
Time frame: Baseline and 3-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40018164McQueen A, Wolff J, Grimes L, Teshome E, Garg R, Thompson T, Carpenter K, Kegler MC, Kreuter MW. Comparing acceptance of smoking cessation and smoke-free home intervention offers and associated factors among people with low income in the USA: baseline results of a randomised controlled trial. BMJ Public Health. 2024 Apr 22;2(1):e000843. doi: 10.1136/bmjph-2023-000843. eCollection 2024 Jun.
- Derived from this study: PubMed 37080354Wolff JM, McQueen A, Garg R, Thompson T, Fu Q, Brown DS, Kegler M, Carpenter KM, Kreuter MW. Expanding population-level interventions to help more low-income smokers quit: Study protocol for a randomized controlled trial. Contemp Clin Trials. 2023 Jun;129:107202. doi: 10.1016/j.cct.2023.107202. Epub 2023 Apr 18.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The HCRL Data Center will make the datasets and other materials available without cost to researchers and analysts after a data sharing agreement is completed. Consistent with NIH guidelines, the data sharing agreement: (1) records a request for data use and detailed description of the intent of use; (2) details the study's publication guidelines, including acknowledging and citing project personnel as appropriate; (3) ensures IRB compliance, including not using these data for non-research purposes; and (4) stipulates that users will not share or distribute the data to others without written permission.
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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.
Matthew Kreuter, Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tobacco Quitline and Smoke Free Home in people with Tobacco Use Cessation and Smoking Behaviors, run by Washington University School of Medicine 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 5 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 10 Oct 2024. 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. 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?
Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
7day Point Prevalence for Smoking (time frame: 6 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04311983, which also lists 2 linked publications.
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 10 Oct 2024.