- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07296848
Health Communications for Adults Smoking Nondaily
April 27, 2026 updated by: Bethany Shorey Fennell, PhD
The goal of this study is to develop smoking health risk messaging targeted to adults who smoke some days, but not smoke every day (nondaily).
The main purpose is to learn what type of smoking health risk messages will be most likely to encourage adults nondaily to quit completely.
Aim 1will iteratively obtain qualitative feedback from adults smoking nondaily on initial message designs, resulting in 12 final messages.
Aim 2 will test message properties using a 2 (health vs. social messages) x 2 (positive vs. negative messages) between subjects design to ascertain which messages promote proximal outcomes associated with quitting cigarettes (e.g., new knowledge, risk perceptions, motivation and intentions to quit).
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
320
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
-
-
Kentucky
-
Lexington, Kentucky, United States, 40506
- University of Kentucky
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- individuals that report smoking at least one combustible cigarette per day on 4-28 days in the past 30 days
- able to read/write in English
- able to give informed consent
- no history of daily smoking
Exclusion Criteria:
- enrolled in smoking cessation treatment
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Positive Health Messaging (PH)
|
Participants will view 3 messages within the assigned condition (PH, PS, NH, NS) in a random order.
Each message will be displayed for a minimum of 30 seconds.
|
|
Active Comparator: Negative Health Messaging (NH)
|
Participants will view 3 messages within the assigned condition (PH, PS, NH, NS) in a random order.
Each message will be displayed for a minimum of 30 seconds.
|
|
Experimental: Positive Social Messaging (PS)
|
Participants will view 3 messages within the assigned condition (PH, PS, NH, NS) in a random order.
Each message will be displayed for a minimum of 30 seconds.
|
|
Experimental: Negative Social Messaging (NS)
|
Participants will view 3 messages within the assigned condition (PH, PS, NH, NS) in a random order.
Each message will be displayed for a minimum of 30 seconds.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Knowledge
Time Frame: Baseline and post-intervention (approximately 1 hour)
|
Knowledge will be assessed with items based on the ITC-4 (International Tobacco Control (ITC) Four Country Survey) that map onto information presented in the messages (e.g., "Does smoking cause…" heart disease, lung cancer in others; Yes, No, I don't know)
|
Baseline and post-intervention (approximately 1 hour)
|
|
Change in Worry
Time Frame: Baseline and post-intervention (approximately 1 hour)
|
Worry will be assessed with 4 items, "How [worried, anxious, fearful, concerned] are you about the effects of smoking?" (1=Not at all, 7=Extremely).
|
Baseline and post-intervention (approximately 1 hour)
|
|
Change in Risk perception
Time Frame: Baseline and post-intervention (approximately 1 hour)
|
Risk perceptions will be assessed with 3 items, "If you [don't/do] quit smoking for good, what are your chances of ever developing a smoking-related health problem?" and "How susceptible do you feel you are to developing a smoking-related health problem?" (1=Lowest susceptibility, 7=Highest susceptibility).
These will be averaged to form a measure of personal absolute risk
|
Baseline and post-intervention (approximately 1 hour)
|
|
Change in the Contemplation Ladder
Time Frame: Baseline and post-intervention (approximately 1 hour)
|
Motivation to quit will be measured with the Contemplation Ladder, rating the position on an 11-rung ladder (0-10) corresponding to stages from "no thought of quitting" (0) to "taking action" (10)
|
Baseline and post-intervention (approximately 1 hour)
|
|
Change in the Motivation to Stop Scale
Time Frame: Baseline and post-intervention (approximately 1 hour)
|
Motivation to quit will be measured with the Motivation to Stop Scale, Level of motivation to stop smoking is measured with seven response categories ranging from 1 (lowest) to level 7 (highest level of motivation to stop smoking)
|
Baseline and post-intervention (approximately 1 hour)
|
|
Change in intention to quit
Time Frame: Baseline and post-intervention (approximately 1 hour)
|
Intention to quit will be measured with the question "What best describes your intent to stop smoking completely, not even a puff?" (1=Never expect to quit, 4=Will quit in the next 30 days)
|
Baseline and post-intervention (approximately 1 hour)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bethany Shorey Fennell, PhD, University of Kentucky
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)
April 17, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Study Registration Dates
First Submitted
December 18, 2025
First Submitted That Met QC Criteria
December 18, 2025
First Posted (Actual)
December 22, 2025
Study Record Updates
Last Update Posted (Actual)
April 28, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 94633
- R03CA286623 (U.S. NIH Grant/Contract)
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.
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