Smoking Clinical Trial
Official title:
Message Testing for Tobacco-Related Corrective Statements
NCT number | NCT01282008 |
Other study ID # | 999911067 |
Secondary ID | 11-C-N067 |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 21, 2011 |
Verified date | January 22, 2019 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
BACKGROUND:
This document outlines the study design and procedures to be used to evaluate a series of
corrective statements to augment consumer knowledge and beliefs about smoking as related to
past actions of tobacco companies. The statements were ordered by a U.S. Federal Court in
U.S. v. Philip Morris USA, Inc., and are intended to target potential misperceptions
resultant of past marketing and promotion practices undertaken by the tobacco industry.
OBJECTIVES:
The U.S. Department of Justice has asked NCI to take the lead on developing and testing
corrective statements with adult and youth audiences to ensure both message comprehension and
avoidance of unintended consequences of message exposure, such as boomerang effects, smoking
triggers, or knowledge gaps.
The court has identified five areas that the statements shall address:
1. The adverse health effects of smoking;
2. The addictiveness of smoking and nicotine;
3. The lack of any significant health benefit from smoking low tar, light, ultra light,
mild, and natural cigarettes;
4. The tobacco industry s manipulation of cigarette design and composition to ensure
optimum nicotine delivery;
5. The adverse health effects of secondhand smoke.
ELIGIBILITY:
Message testing will be undertaken with the following audiences:
- Current smokers (with an oversample of low socioeconomic status individuals)
- General population nonsmokers and former smokers (with an oversample of low
socioeconomic status individuals)
- Spanish-speaking Hispanics
- Youth age 14-17
DESIGN:
Both qualitative and quantitative methods (focus groups and post-test comparison group
Web-enabled surveys) will be used to develop and test a range of corrective statements in the
five areas outlined by the court.
- Focus group participants: 48-64
- Survey participants: 2500
Status | Completed |
Enrollment | 627 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 17 Years |
Eligibility |
- INCLUSION CRITERIA: - Youth age 14-17 - Youth current smokers, former smokers, and never smokers - Youth male and female genders - Youth of all race/ethnicity categories, including: White, Black/African American, Asian, Hispanic/Latino, American Indian/Alaskan Native, Native Hawaiian/Pacific Islander EXCLUSION CRITERIA: Participants will be excluded from focus groups and survey if they work in: - Media - Advertising, market research - Public health or health promotion - An employee of the Federal Govemment who works at HHS or DoJ - The tobacco or alcohol industries |
Country | Name | City | State |
---|---|---|---|
United States | National Cancer Institute (NCI), 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Ayanian JZ, Cleary PD. Perceived risks of heart disease and cancer among cigarette smokers. JAMA. 1999 Mar 17;281(11):1019-21. — View Citation
Evans WD, Crankshaw E, Nimsch C, Morgan-Lopez A, Farrelly MC, Allen J. Media and secondhand smoke exposure: results from a national survey. Am J Health Behav. 2006 Jan-Feb;30(1):62-71. — View Citation
Stryker JE, Moriarty CM, Jensen JD. Effects of newspaper coverage on public knowledge about modifiable cancer risks. Health Commun. 2008 Jul;23(4):380-90. doi: 10.1080/10410230802229894. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knowledge | Tobacco-related knowledge, attitudes, and beliefs were measured at baseline and after exposure to message stimuli. | Immediately upon exposure to stimuli |
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