Interventions to Help More Low-income Smokers Quit
SFH
Expanding Population-level Interventions to Help More Low-income Smokers Quit
2 other identifiers
interventional
1,973
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2020
CompletedFirst Posted
Study publicly available on registry
March 17, 2020
CompletedStudy Start
First participant enrolled
March 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2023
CompletedResults Posted
Study results publicly available
October 10, 2024
CompletedOctober 10, 2024
October 1, 2024
3.5 years
March 10, 2020
September 11, 2024
October 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
7day Point Prevalence for Smoking
Percentage of participants who have 7 day smoking abstinence
6 month follow-up
Secondary Outcomes (1)
Proportion of Participants Who Accept the Tobacco Quitline Program
Baseline and 3-month follow-up
Study Arms (2)
Tobacco Quitline only
ACTIVE COMPARATORSmokers in this study group will be offered their state Tobacco Quitline programs
Tobacco Quitline plus Smoke Free Homes
EXPERIMENTALSmokers 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
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").
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant women, because recommended tobacco cessation actions differ for this subset of smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Publications (2)
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.
PMID: 40018164DERIVEDWolff 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.
PMID: 37080354DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Matthew Kreuter, Ph.D.
- Organization
- Washington University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Kreuter, Ph.D.
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Participants are unaware of the arms and principal investigators are unaware of participant's randomization to study arm
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2020
First Posted
March 17, 2020
Study Start
March 31, 2020
Primary Completion
September 29, 2023
Study Completion
September 29, 2023
Last Updated
October 10, 2024
Results First Posted
October 10, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
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.