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

Primary Purpose

Nicotine Dependence

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exposure to smoking advertising with coupon

Exposure to smoking advertising without coupons

Exposure to non health related images

About this trial

This is an interventional other trial for Nicotine Dependence focused on measuring Cigarettes, Behaviors, Attitudes, Beliefs

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

National Institutes of Health Clinical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

1/Part 1

2/Part 2 - Discount Coupons

3/Part 2 - No Discount Coupons

4/Part 2 - Control

Arm Description

60 Participants of high and low SES

Randomized to view direct mail marketing

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02974582

First Posted

November 22, 2016

Last Updated

September 30, 2023

Sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

1. Study Identification

Unique Protocol Identification Number

NCT02974582

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 9, 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 5, 2023 (Anticipated)

Primary Completion Date

October 6, 2025 (Anticipated)

Study Completion Date

October 6, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nicotine Dependence

Keywords

Cigarettes, Behaviors, Attitudes, Beliefs

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

530 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1/Part 1

Arm Type

Experimental

Arm Description

60 Participants of high and low SES

Arm Title

2/Part 2 - Discount Coupons

Arm Type

Experimental

Arm Description

Randomized to view direct mail marketing

Arm Title

3/Part 2 - No Discount Coupons

Arm Type

Experimental

Arm Description

Randomized to view direct mail marketing

Arm Title

4/Part 2 - Control

Arm Type

Experimental

Arm Description

Randomized to view direct mail marketing

Intervention Type

Behavioral

Intervention Name(s)

Exposure to smoking advertising with coupon

Intervention Description

Direct mail marketing of smoking advertising with discount coupon

Intervention Type

Behavioral

Intervention Name(s)

Exposure to smoking advertising without coupons

Intervention Description

Direct mail marketing of smoking advertising without discount coupon

Intervention Type

Behavioral

Intervention Name(s)

Exposure to non health related images

Intervention Description

Control group

Primary Outcome Measure Information:

Title

To collect pilot data to examine the variability in beliefs, affective responses, and arousal between young adult smokers of high and low socioeconomic status.

Description

Measure of physiological responses.

Time Frame

1 Day

Title

Description

Measure of physiological responses.

Time Frame

1 Day

Secondary Outcome Measure Information:

Title

To select cigarette direct mail marketing materials that are perceived to be similar in their persuasiveness for Part 2 of the study.

Description

Measure of physiological responses.

Time Frame

1 Day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

29 Years

Accepts Healthy Volunteers

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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bambi JE Jewett

Phone

(301) 827-0493

bambi.jewett@nih.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Tsz (Kelvin) C Choi, Ph.D.

Phone

(301) 496-3400

tsz.choi@nih.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tsz (Kelvin) C Choi, Ph.D.

Organizational Affiliation

National Institute on Minority Health and Health Disparities (NIMHD)

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institutes of Health Clinical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Phone

800-411-1222

Ext

TTY8664111010

prpl@cc.nih.gov

12. IPD Sharing Statement

Links:

URL

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2017-MD-0015.html

Description

NIH Clinical Center Detailed Web Page

Learn more about this trial

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

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