NCT05273450

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2022

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2022

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

March 1, 2022

Last Update Submit

March 7, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    3 months

Study Arms (2)

Quitline Information with Reinforcement

EXPERIMENTAL
Behavioral: Quitline Information with Reinforcement

Quitline Information Only

NO INTERVENTION

Interventions

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.

Quitline Information with Reinforcement

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 1, 2022

First Posted

March 10, 2022

Study Start

February 14, 2022

Primary Completion

August 22, 2022

Study Completion

August 22, 2022

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations