- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02974582
Understanding How Cigarette Direct Mail Marketing Influences Smoking Behaviors Among High and Low Socioeconomic Status Young Adult Smokers
Understanding How Cigarette Direct Mail Marketing Influence Smoking Behaviors Among High and Low Socioeconomic Status Young Adult Smokers
Background:
Smoking is a major public health problem in the U.S. Almost a half a million Americans die from it in a year. One thing that contributes to why people smoke is the marketing of cigarettes. Cigarette direct mail marketing usually targets young smokers of lower socioeconomic status. Researchers want to find out more about how this kind of marketing influences smoking behavior in young people from different socioeconomic levels.
Objectives:
To study the effects of cigarette direct mail marketing on beliefs, responses, and arousal. To study how these things may differ among young adult smokers of high and low socioeconomic status.
Eligibility:
Volunteer adults ages 18 to 29 who smoke.
Design:
Participants will have 1 visit.
Participants will be asked questions about their health and recent smoking.
A nurse will check their vital signs.
Participants will have a simple eye exam.
They will give blood and urine samples.
Participants will be connected to equipment. This will collect data while they look at pictures.
Then they will have a 10-minute break. A nurse will observe them during the break.
Participants will have their breath analyzed.
Participants will answer questions. The topics will include:
Education
Job
Income
Family history
Tobacco use
Exposure to pro-smoking and anti-smoking messages
History of drug and alcohol use
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bambi JE Jewett
- Phone Number: (301) 827-0493
- Email: bambi.jewett@nih.gov
Study Contact Backup
- Name: Kelvin C Choi, Ph.D.
- Phone Number: (301) 496-3400
- Email: tsz.choi@nih.gov
Study Locations
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-
Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
-
Contact:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- Phone Number: TTY8664111010 800-411-1222
- Email: prpl@cc.nih.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
- INCLUSION CRITERIA:
- Age: 18 to 29 years, given our focus on young adults.
- Smoking status: Current smokers who report smoking every day and who have smoked at least 100 cigarettes in their lifetime with a breath carbon monoxide level greater than 6ppm per device guidelines
SES: For the purpose of the study, we will use the empirical groups from our analysis of the Current Population Survey -Tobacco Use Supplement data. Two groups are chosen based on their social determinants and prevalence of smoking.
- Low SES: Young adults who do not have a four-year college degree, are not currently enrolled in a four-year college, were born in the US, and have an annual income less than $50,000. This is the group that has been shown to have the highest prevalence of smoking.
- High SES: Young adults who are currently enrolled in or graduated from a four year college. This is the group that has been shown to have the lowest prevalence of smoking.
- English proficiency: since study materials are available only in English, only participants who are able to understand English and follow instructions in English are to be enrolled.
- Cognitive ability: Able to understand and willing to sign a written informed consent document.
- General health: Participants need to be generally healthy, as defined as someone with no known significant health problems. Participants can have chronic health conditions if the condition is well managed.
EXCLUSION CRITERIA:
- Inability, in the judgment of the investigator, to understand and follow the requirements of the protocol.
- Currently enrolled in high school.
- Participants with eye conditions that restrict their ability to track an object with their eyes.
- Participants with myopia, hyperopia, and/or astigmatism who cannot pass a simple vision test even with corrective lenses.
- Participants with medical condition(s) that may be triggered by infrared radiation (e.g., epilepsy).
- Self-reported use of alcohol, recreational drugs or prescription medications used for recreational purposes (e. g. amphetamines, cannabis, cocaine, MDMA, ketamines, LSD, opiates and opioids, tranquilizers or opioid analgesics) that may influence their judgement at the time of study in the past 12 hours before the study visit.
- Participants who cannot see an object located between 15 to 27 inches away from them (the required distance between the computer screen and the participants for accurate eye-tracking), even with corrective contact lenses.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1/Part 1
60 Participants of high and low SES
|
Control group
|
Experimental: 2/Part 2 - Discount Coupons
Randomized to view direct mail marketing
|
Direct mail marketing of smoking advertising with discount coupon
|
Experimental: 3/Part 2 - No Discount Coupons
Randomized to view direct mail marketing
|
Direct mail marketing of smoking advertising without discount coupon
|
Experimental: 4/Part 2 - Control
Randomized to view direct mail marketing
|
Control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To collect pilot data to examine the variability in beliefs, affective responses, and arousal between young adult smokers of high and low socioeconomic status.
Time Frame: 1 Day
|
Measure of physiological responses.
|
1 Day
|
To conduct a randomized comparative trial to examine the effect of cigarette direct mail materials on beliefs, affective responses, arousal, and smoking behavior, and their variation by SES among young adult smokers.
Time Frame: 1 Day
|
Measure of physiological responses.
|
1 Day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To select cigarette direct mail marketing materials that are perceived to be similar in their persuasiveness for Part 2 of the study.
Time Frame: 1 Day
|
Measure of physiological responses.
|
1 Day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kelvin C Choi, Ph.D., National Institute on Minority Health and Health Disparities (NIMHD)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 170015
- 17-MD-0015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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