SmokingNCT05231421
A Focus Group Study to Explore Smoking Triggers and Acceptability of Just-in-time Adaptive Intervent
An observational study of Smoking and Smoking Cessation, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This research intends to identify common smoking triggers and barriers to quitting smoking; understand useful and effective strategies for smoking cessation; and explore the feasibility and acceptability of mobile phone-based interventions among low-income smokers. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Smoking, Smoking Cessation, Smoking Behaviors
- What is being tested?
- Focus Group
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2020to 1 Feb 2025
- Phase
- Observational
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will recruit low-income current smokers
Who may be able to join
- between 18 and 89 years old
- current smokers
- reside in Denver Metropolitan Area
- have a personal cell phone
- have a household income at or lower than 200% of the federal poverty level; and
- ability to read and speak English or Spanish (since a large proportion of the low-SES population in Denver are Spanish speakers).
Who cannot join
- Unable to provide informed consent;
- age ≥ 89 years;
- unable to speak or understand English, or Spanish.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Focus Group Study to Explore Smoking Triggers and Acceptability of Just-in-time Adaptive Interventions (JITAI) for Smoking Cessation Among Low-income Smokers
This research intends to identify common smoking triggers and barriers to quitting smoking; understand useful and effective strategies for smoking cessation; and explore the feasibility and acceptability of mobile phone-based interventions among low-income smokers.
Read the detailed description
This research intends to identify common smoking triggers and barriers to quitting smoking; understand useful and effective strategies for smoking cessation; and explore the feasibility and acceptability of mobile phone-based interventions among low-income smokers.
Specific research questions of this research project are:
- What are the common smoking triggers and barriers to quitting smoking for low-income smokers?
- What are the preferred and useful smoking cessation strategies based on low-income smokers quitting experience?
- What is the feasibility and acceptability of using a) text messages, b) virtual reality programs, and c) just-in-time adaptive smoking cessation interventions among low-income smokers?
- Conditions
- Smoking, Smoking Cessation, Smoking Behaviors
- Being tested
- Focus Group
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupBehavioural
Each focus group will consist of 5-10 participants. They will first introduce to each other and be asked to keep information shared during the session private. The moderator will initiate some questions for the group to discuss. Prompt and follow-up questions will be asked. There is no right or wrong answer for each question and no sensitive questions will be asked. The conversations during the focus group discussion will be recorded. The group will be debriefed about the purpose of the study and have a chance to ask any questions about the study if they have. The focus group discussion for each session will last about 60-90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Low-income smokers | Interested participants will first complete a screening survey asking about their demographic information and checking whether are eligible for this study. If eligible, participants will read a consent statement. Only those who give consent would be allowed to proceed. If participants agree to be in this study, they will continue to participate in the study and schedule a time for focus group discussion. Receives: Behavioral: Focus Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use focus group discussion to identify barriers faced by low-income smokers
This study intends to identify the barriers faced by low-income smokers to obtaining smoking cessation services/support using focus groups of current smokers.
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 posted9 Feb 2022
- Study start18 Jan 2020
- Primary completion31 Aug 2022
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Shuo Zhou, Principal investigator, Colorado Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231421
- Sponsor's protocol ID
- 19-2555.cc
- Status last verified
- Feb 2025
- First submitted
- 21 Dec 2021
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Focus Group Study to Explore Smoking Triggers and Acceptability of Just-in-time Adaptive Interventions (JITAI) for Smoking Cessation Among Low-income Smokers
- ClinicalTrials.gov ID
- NCT05231421
- Acronym / sponsor ID
- 19-2555.cc
- Conditions
- Smoking, Smoking Cessation, Smoking Behaviors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 18 Jan 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 9 Feb 2022 (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.
This research intends to identify common smoking triggers and barriers to quitting smoking; understand useful and effective strategies for smoking cessation; and explore the feasibility and acceptability of mobile phone-based interventions among low-income smokers.
Detailed description
This research intends to identify common smoking triggers and barriers to quitting smoking; understand useful and effective strategies for smoking cessation; and explore the feasibility and acceptability of mobile phone-based interventions among low-income smokers.
Specific research questions of this research project are:
- What are the common smoking triggers and barriers to quitting smoking for low-income smokers?
- What are the preferred and useful smoking cessation strategies based on low-income smokers quitting experience?
- What is the feasibility and acceptability of using a) text messages, b) virtual reality programs, and c) just-in-time adaptive smoking cessation interventions among low-income smokers?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-income smokers | – | Behavioral: Focus GroupInterested participants will first complete a screening survey asking about their demographic information and checking whether are eligible for this study. If eligible, participants will read a consent statement. Only those who give consent would be allowed to proceed. If participants agree to be in this study, they will continue to participate in the study and schedule a time for focus group discussion. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit low-income current smokers
Key inclusion criteria (6 listed)
- between 18 and 89 years old
- current smokers
- reside in Denver Metropolitan Area
- have a personal cell phone
- have a household income at or lower than 200% of the federal poverty level; and
Key exclusion criteria (3 listed)
- Unable to provide informed consent;
- age ≥ 89 years;
- unable to speak or understand English, or Spanish.
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 |
|---|---|---|
| Focus GroupEach focus group will consist of 5-10 participants. They will first introduce to each other and be asked to keep information shared during the session private. The moderator will initiate some questions for the group to discuss. Prompt and follow-up questions will be asked. There is no right or wrong answer for each question and no sensitive questions will be asked. The conversations during the focus group discussion will be recorded. The group will be debriefed about the purpose of the study and have a chance to ask any questions about the study if they have. The focus group discussion for each session will last about 60-90 minutes. | Behavioural | Low-income smokers |
Primary outcome
Use focus group discussion to identify barriers faced by low-income smokers
Time frame: 12 months
This study intends to identify the barriers faced by low-income smokers to obtaining smoking cessation services/support using focus groups of current smokers.
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 Feb 2025.
- 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.
Shuo Zhou principal investigator
Colorado Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and Smoking Cessation, run by University of Colorado, Denver 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 6 inclusion and 3 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 Feb 2025. 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?
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?
Use focus group discussion to identify barriers faced by low-income smokers (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 Feb 2025.