Smoking CessationNCT05273450
An Intervention to Promote Use of Smoking Cessation Resources Among Adults Using Community Food Pantries
A study testing Quitline Information with Reinforcement in people with Smoking Cessation and Food Insecurity, run by Case Western Reserve University at 1 site in United States.
Trial summary
The primary objective of this pilot randomized controlled study is to raise awareness and use of an evidence-based tobacco cessation resource that is underutilized among smokers (the Ohio Tobacco Quitline), specifically targeting Cleveland-area residents who have experiences with food insecurity. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Smoking Cessation, Food Insecurity
- What is being tested?
- Quitline Information with Reinforcement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2022to 22 Aug 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 21 or older
- Current tobacco smoker willing to receive information about quitting resources
- Lives in Cuyahoga County, Ohio
- Has a reliable telephone number and an email address
Who cannot join
- Aged 20 or younger
- Current non-smoker, or current smoking who is not willing to receive information about quitting resources
- Lives outside Cuyahoga County, Ohio
- Does not have a reliable telephone number and an email address
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44106
About this study
Official title: Promoting Smoking Cessation Among Individuals With Food Insecurity: Promoting the Use of Evidence-Based Tobacco Cessation Resources Through Community Food Pantries
The primary objective of this pilot randomized controlled study is to raise awareness and use of an evidence-based tobacco cessation resource that is underutilized among smokers (the Ohio Tobacco Quitline), specifically targeting Cleveland-area residents who have experiences with food insecurity. The study will assess the feasibility and acceptability of conducting informational outreach on tobacco cessation resources in community settings in which there is a relatively high proportion of tobacco users (i.e., food pantries). The study will derive preliminary estimates regarding the effectiveness of tobacco cessation outreach, by assessing whether outreach activities result in changes in awareness/knowledge of the quitline and use/engagement of the quitline.
- Conditions
- Smoking Cessation, Food Insecurity
- Being tested
- Quitline Information with Reinforcement
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quitline Information with ReinforcementBehavioural
The intervention arm involves direct referral to the Ohio Tobacco Quitline, with up to two brief follow-up telephone calls from the research team to elicit motivation to quit, emphasize benefits of calling the quitline, encourage use and address concerns. Participants are surveyed at baseline and at 3-month follow-up to assess awareness and use of the quitline.
| Study group | Role | What they receive |
|---|---|---|
| Quitline Information with Reinforcement | Experimental | Not described Receives: Behavioral: Quitline Information with Reinforcement |
| Quitline Information Only | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awareness of the quitline
How familiar are you with the Ohio Tobacco Quitline? (a) Not familiar at all - I have not heard about the quitline, (b) Somewhat familiar - I have heard of the quit line but have not used it, (c) Familiar - I have used their services but it was over a year ago, (d) Very familiar - I am currently connected to their services
Measured: 3 months
Use of the quitline
After enrolling in this research study [past 3 months], did you receive a referral to the Ohio Tobacco Quitline? (a) Yes, and I enrolled, (b) Yes, but I did not enroll, (c) No
Measured: 3 months
Use of the quitline
In the past 3 months, which of the following methods did you try to stop smoking? 'Called the Ohio Tobacco Quitline' is checked
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 posted10 Mar 2022
- Study start14 Feb 2022
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
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.
- 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
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Kim-Mozeleski, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273450
- Sponsor's protocol ID
- Kim-MozeleskiStudy20211283
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Smoking Cessation Among Individuals With Food Insecurity: Promoting the Use of Evidence-Based Tobacco Cessation Resources Through Community Food Pantries
- ClinicalTrials.gov ID
- NCT05273450
- Acronym / sponsor ID
- Kim-MozeleskiStudy20211283
- Conditions
- Smoking Cessation, Food Insecurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 10 Mar 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.
The primary objective of this pilot randomized controlled study is to raise awareness and use of an evidence-based tobacco cessation resource that is underutilized among smokers (the Ohio Tobacco Quitline), specifically targeting Cleveland-area residents who have experiences with food insecurity. The study will assess the feasibility and acceptability of conducting informational outreach on tobacco cessation resources in community settings in which there is a relatively high proportion of tobacco users (i.e., food pantries). The study will derive preliminary estimates regarding the effectiveness of tobacco cessation outreach, by assessing whether outreach activities result in changes in awareness/knowledge of the quitline and use/engagement of the quitline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quitline Information with Reinforcement | Experimental | Behavioral: Quitline Information with Reinforcement |
| Quitline Information Only | No intervention | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 21 or older
- Current tobacco smoker willing to receive information about quitting resources
- Lives in Cuyahoga County, Ohio
- Has a reliable telephone number and an email address
Key exclusion criteria (4 listed)
- Aged 20 or younger
- Current non-smoker, or current smoking who is not willing to receive information about quitting resources
- Lives outside Cuyahoga County, Ohio
- Does not have a reliable telephone number and an email address
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 |
|---|---|---|
| Quitline Information with ReinforcementThe intervention arm involves direct referral to the Ohio Tobacco Quitline, with up to two brief follow-up telephone calls from the research team to elicit motivation to quit, emphasize benefits of calling the quitline, encourage use and address concerns. Participants are surveyed at baseline and at 3-month follow-up to assess awareness and use of the quitline. | Behavioural | Quitline Information with Reinforcement |
Primary outcome
Awareness of the quitline
Time frame: 3 months
How familiar are you with the Ohio Tobacco Quitline? (a) Not familiar at all - I have not heard about the quitline, (b) Somewhat familiar - I have heard of the quit line but have not used it, (c) Familiar - I have used their services but it was over a year ago, (d) Very familiar - I am currently connected to their services
Use of the quitline
Time frame: 3 months
After enrolling in this research study [past 3 months], did you receive a referral to the Ohio Tobacco Quitline? (a) Yes, and I enrolled, (b) Yes, but I did not enroll, (c) No
Use of the quitline
Time frame: 3 months
In the past 3 months, which of the following methods did you try to stop smoking? 'Called the Ohio Tobacco Quitline' is checked
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 12 Mar 2024.
- 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.
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 Quitline Information with Reinforcement in people with Smoking Cessation and Food Insecurity, run by Case Western Reserve 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 4 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 12 Mar 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?
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?
Awareness of the quitline (time frame: 3 months). The study lists 3 primary outcomes in all. 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 12 Mar 2024.