- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05273450
An Intervention to Promote Use of Smoking Cessation Resources Among Adults Using Community Food Pantries
March 7, 2024 updated by: Jin Kim-Mozeleski, Case Western Reserve University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Case Western Reserve University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Quitline Information with Reinforcement
|
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.
|
|
No Intervention: Quitline Information Only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3 months
|
|
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
|
3 months
|
|
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
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 14, 2022
Primary Completion (Actual)
August 22, 2022
Study Completion (Actual)
August 22, 2022
Study Registration Dates
First Submitted
March 1, 2022
First Submitted That Met QC Criteria
March 1, 2022
First Posted (Actual)
March 10, 2022
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 7, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Kim-MozeleskiStudy20211283
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.