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Understanding How Cigarette Direct Mail Marketing Influences Smoking Behaviors Among High and Low Socioeconomic Status Young Adult Smokers

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ClinicalTrials.gov Identifier: NCT02974582
Recruitment Status : Recruiting
First Posted : November 28, 2016
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Minority Health and Health Disparities (NIMHD) )

Brief Summary:

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:

Healthy 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


Condition or disease
Nicotine Dependence

Detailed Description:
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 prosed 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 healthy 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.

Study Type : Observational
Estimated Enrollment : 530 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Understanding How Cigarette Direct Mail Marketing Influences Smoking Behaviors Among High and Low Socioeconomic Status Young Adult Smokers
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : October 6, 2021
Estimated Study Completion Date : October 6, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Group/Cohort
High SES
Experimental
Low SES
Experimental



Primary Outcome Measures :
  1. Perceived persuasiveness of advertisement [ Time Frame: During the study ]
    Participants rate the persuasiveness of each tobacco advertisement seen during the experiment


Secondary Outcome Measures :
  1. Event-related potentials, visual attention, affective reponses [ Time Frame: during the study ]
    Measures are being passively captured throughout the experiment as participants are going through the images of advertisement and references



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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers, young adult smokers (ages 18-29 years old) of high SES will be recruited.
Criteria
  • 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.
  • Gender: Both male and female
  • 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.

    1. 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.
    2. 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. i. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974582


Contacts
Contact: Tsz (Kelvin) C Choi, Ph.D. (301) 496-3400 tsz.choi@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Tsz (Kelvin) C Choi, Ph.D. National Institute on Minority Health and Health Disparities (NIMHD)

Additional Information:
Responsible Party: National Institute on Minority Health and Health Disparities (NIMHD)
ClinicalTrials.gov Identifier: NCT02974582     History of Changes
Other Study ID Numbers: 170015
17-MD-0015
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 26, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Minority Health and Health Disparities (NIMHD) ):
Marketing
Smoking
Cigarette
Young Adult
Socioeconomic Status
Behaviors
Attitudes
Beliefs

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders