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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01282008
Other study ID # 999911067
Secondary ID 11-C-N067
Status Completed
Phase
First received
Last updated
Start date January 21, 2011

Study information

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

Clinical Trial Summary

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


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:

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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Cancer Institute (NCI), 9000 Rockville Pike Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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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