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| ID | Type | Description | Link |
|---|---|---|---|
| 17-MD-0015 |
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Study closed due to staffing, operational, and technical challenges that have prevented study initiation; no participant activities or data collection have occurred.
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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
Smoking remains a public health problem in the US, and cigarette marketing has been concluded as one of the causal factors for the epidemic. Previous studies on cigarette direct mail marketing yielded a limited data on mechanisms influencing smoking behavior. Therefore, there is a need for a study that would provide a stronger evidence on how direct mail marketing influences smoking behavior. The proposed study will consist of two parts where pilot data are to be collected in Part 1, and further data are to be collected in Part 2 conducted as a randomized comparative trial. Up to a total of 530 volunteers ages 18-29 are to be recruited for the study. After meeting the eligibility and enrolling onto the study, participants will have their biospecimens collected followed by an experiment in which they are to be shown images on the computer. Study participants will then take a break and afterwards will provide additional sociodemographic and psychosocial information through an audio computer assisted self-administered interview.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1/Part 1 | Experimental | 60 Participants of high and low SES |
|
| 2/Part 2 - Discount Coupons | Experimental | Randomized to view direct mail marketing |
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| 3/Part 2 - No Discount Coupons | Experimental | Randomized to view direct mail marketing |
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| 4/Part 2 - Control | Experimental | Randomized to view direct mail marketing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure to smoking advertising with coupon | Behavioral | Direct mail marketing of smoking advertising with discount coupon |
|
| 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. | 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. | Measure of physiological responses. | 1 Day |
| 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. | Measure of physiological responses. | 1 Day |
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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.
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:
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| Name | Affiliation | Role |
|---|---|---|
| Tsz Chun Choi, Ph.D. | National Institute on Minority Health and Health Disparities (NIMHD) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
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| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| Exposure to smoking advertising without coupons | Behavioral | Direct mail marketing of smoking advertising without discount coupon |
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| Exposure to non health related images | Behavioral | Control group |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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