Message Testing for Tobacco-Related Corrective Statements

Smoking Clinical Trial

Official title:

Message Testing for Tobacco-Related Corrective Statements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01282008
• Other study ID #: 999911067
• Secondary ID: 11-C-N067
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Communication
• Smoking
• Tobacco

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