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

• ClinicalTrials.gov Identifier: NCT02974582
• Recruitment Status: Not yet recruiting
• First Posted: November 28, 2016
• Last Update Posted: June 9, 2023
• Sponsor: National Institute on Minority Health and Health Disparities (NIMHD)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Institute on Minority Health and Health Disparities (NIMHD) )

Tracking Information

• First Submitted Date: November 22, 2016
• First Posted Date: November 28, 2016
• Last Update Posted Date: June 9, 2023
• Estimated Study Start Date: November 5, 2023
• Estimated Primary Completion Date: October 6, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 8, 2019)

• 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.
• 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.

Original Primary Outcome Measures (submitted: November 23, 2016)

• To collect pilot data to examine the variability in beliefs, effective responses, and arousal to cigarette direct mail marketing materials between young adult smokers of high and low socioeconomic status. [ Time Frame: 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 ]

Current Secondary Outcome Measures (submitted: October 8, 2019)

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.

• Original Secondary Outcome Measures (submitted: November 23, 2016): 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 ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Understanding How Cigarette Direct Mail Marketing Influences Smoking Behaviors Among High and Low Socioeconomic Status Young Adult Smokers
• Official Title: Understanding How Cigarette Direct Mail Marketing Influence Smoking Behaviors Among High and Low Socioeconomic Status Young Adult Smokers

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...

• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Nicotine Dependence

Intervention

• Behavioral: Exposure to smoking advertising with coupon
  Direct mail marketing of smoking advertising with discount coupon
• Behavioral: Exposure to smoking advertising without coupons
  Direct mail marketing of smoking advertising without discount coupon
• Behavioral: Exposure to non health related images
  Control group

Study Arms

• Experimental: 1/Part 1
  60 Participants of high and low SES
  Intervention: Behavioral: Exposure to non health related images
• Experimental: 2/Part 2 - Discount Coupons
  Randomized to view direct mail marketing
  Intervention: Behavioral: Exposure to smoking advertising with coupon
• Experimental: 3/Part 2 - No Discount Coupons
  Randomized to view direct mail marketing
  Intervention: Behavioral: Exposure to smoking advertising without coupons
• Experimental: 4/Part 2 - Control
  Randomized to view direct mail marketing
  Intervention: Behavioral: Exposure to non health related images

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: November 23, 2016): 530
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 6, 2027
• Estimated Primary Completion Date: October 6, 2025 (Final data collection date for primary outcome measure)

Eligibility 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 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.

  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. 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 29 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Bambi JE Jewett; (301) 827-0493; bambi.jewett@nih.gov

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02974582
• Other Study ID Numbers: 170015; 17-MD-0015
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Minority Health and Health Disparities (NIMHD) )
• Original Responsible Party: Same as current
• Current Study Sponsor: National Institute on Minority Health and Health Disparities (NIMHD)
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Tsz (Kelvin) C Choi, Ph.D.; National Institute on Minority Health and Health Disparities (NIMHD)

• PRS Account: National Institutes of Health Clinical Center (CC)
• Verification Date: May 9, 2023