- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01282008
Message Testing for Tobacco-Related Corrective Statements
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:
- The adverse health effects of smoking;
- The addictiveness of smoking and nicotine;
- The lack of any significant health benefit from smoking low tar, light, ultra light, mild, and natural cigarettes;
- The tobacco industry s manipulation of cigarette design and composition to ensure optimum nicotine delivery;
- 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
Study Overview
Status
Conditions
Detailed Description
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:
- The adverse health effects of smoking;
- The addictiveness of smoking and nicotine;
- The lack of any significant health benefit from smoking low tar, light, ultra light, mild, and natural cigarettes;
- The tobacco industry s manipulation of cigarette design and composition to ensure optimum nicotine delivery;
- 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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
Maryland
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Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI), 9000 Rockville Pike
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
|---|
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Focus Groups
Focus Groups about smoking messages
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge
Time Frame: Immediately upon exposure to stimuli
|
Tobacco-related knowledge, attitudes, and beliefs were measured at baseline and after exposure to message stimuli.
|
Immediately upon exposure to stimuli
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kelly D Blake, D.Sc., National Cancer Institute (NCI)
Publications and helpful links
General Publications
- Ayanian JZ, Cleary PD. Perceived risks of heart disease and cancer among cigarette smokers. JAMA. 1999 Mar 17;281(11):1019-21. doi: 10.1001/jama.281.11.1019.
- 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. doi: 10.5555/ajhb.2006.30.1.62.
- 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.
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 999911067
- 11-C-N067
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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