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Interventions to Help More Low-income Smokers Quit

Expanding Population-level Interventions to Help More Low-income Smokers Quit

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04311983
Acronym
SFH
Enrollment
1973
Registered
2020-03-17
Start date
2020-03-31
Completion date
2023-09-29
Last updated
2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use Cessation, Smoking Behaviors, Health Disparity

Brief 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.

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?

Interventions

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).

BEHAVIORALSmoke Free Home

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.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Masking description

Participants are unaware of the arms and principal investigators are unaware of participant's randomization to study arm

Intervention model description

Two group intervention; standard care vs. standard + additional service

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

-Pregnant women, because recommended tobacco cessation actions differ for this subset of smokers

Design outcomes

Primary

MeasureTime frameDescription
7day Point Prevalence for Smoking6 month follow-upPercentage of participants who have 7 day smoking abstinence

Secondary

MeasureTime frameDescription
Proportion of Participants Who Accept the Tobacco Quitline ProgramBaseline and 3-month follow-up* 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Tobacco Quitline Only
Smokers in this study group will be offered their state Tobacco Quitline programs
987
Tobacco Quitline Plus Smoke Free Homes
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
986
Total1,973

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath10
Overall StudyIncomplete survey79
Overall StudyLost to Follow-up421456

Baseline characteristics

CharacteristicTobacco Quitline Plus Smoke Free HomesTotalTobacco Quitline Only
Age, Continuous51 years51 years51 years
Ethnicity (NIH/OMB)
Hispanic or Latino
52 Participants98 Participants46 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
928 Participants1867 Participants939 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
6 Participants8 Participants2 Participants
Race/Ethnicity, Customized
American Indian/Alaskan Native
17 Participants31 Participants14 Participants
Race/Ethnicity, Customized
Asian/Asian American
0 Participants2 Participants2 Participants
Race/Ethnicity, Customized
Black/African American
406 Participants811 Participants405 Participants
Race/Ethnicity, Customized
Multiracial
52 Participants117 Participants65 Participants
Race/Ethnicity, Customized
Native Hawaiian/Pacific
3 Participants4 Participants1 Participants
Race/Ethnicity, Customized
Other
27 Participants64 Participants37 Participants
Race/Ethnicity, Customized
Unknown/Missing
18 Participants25 Participants7 Participants
Race/Ethnicity, Customized
White
463 Participants919 Participants456 Participants
Region of Enrollment
United States
986 participants1973 participants987 participants
Sex/Gender, Customized
Female
677 Participants1342 Participants665 Participants
Sex/Gender, Customized
Male
304 Participants621 Participants317 Participants
Sex/Gender, Customized
Unknown
5 Participants10 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 9870 / 986
other
Total, other adverse events
0 / 9870 / 986
serious
Total, serious adverse events
0 / 9870 / 986

Outcome results

Primary

7day Point Prevalence for Smoking

Percentage of participants who have 7 day smoking abstinence

Time frame: 6 month follow-up

Population: Participants were not included if they were lost to follow-up or were duplicate enrollees.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Tobacco Quitline Only7day Point Prevalence for Smoking78 Participants
Tobacco Quitline Plus Smoke Free Homes7day Point Prevalence for Smoking83 Participants
Secondary

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.

Time frame: Baseline and 3-month follow-up

Population: At baseline, participants weren't included if they were duplicate entries. At 3-month follow-up, participants weren't included if they were duplicated entries or if they were lost to follow-up. Also, in Arm 2 at 3-month follow-up, if participants had chosen the quitline at baseline and did not quit, they were not re-offered the quitline; they were only offered Smoke-Free Homes. This was a planned part of the study design.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Tobacco Quitline OnlyProportion of Participants Who Accept the Tobacco Quitline ProgramBaseline592 Participants
Tobacco Quitline OnlyProportion of Participants Who Accept the Tobacco Quitline Program3-month follow-up385 Participants
Tobacco Quitline Plus Smoke Free HomesProportion of Participants Who Accept the Tobacco Quitline ProgramBaseline587 Participants
Tobacco Quitline Plus Smoke Free HomesProportion of Participants Who Accept the Tobacco Quitline Program3-month follow-up142 Participants

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026