TobaccoNCT01282008
Message Testing for Tobacco-Related Corrective Statements
An observational study of Tobacco and Smoking, run by National Cancer Institute (NCI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Tobacco, Smoking, Communication
- How many people
- 627 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2011to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Random sample of GfK Web panel participants.@@@@@@
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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
Read the 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
- Conditions
- Tobacco, Smoking, Communication
- Keywords
- Online Surveys, Tobacco Corrective Statements, Message Testing, Focus Groups
- Medical subject headings
- Smoking, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Focus Groups | Focus Groups about smoking messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge
Tobacco-related knowledge, attitudes, and beliefs were measured at baseline and after exposure to message stimuli.
Measured: Immediately upon exposure to stimuli
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study start21 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TobaccoStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 627 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kelly D Blake, D.Sc., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282008
- Sponsor's protocol ID
- 999911067
- Other IDs
- 11-C-N067
- Status last verified
- 22 Jan 2019
- First submitted
- 21 Jan 2011
- Last updated
- 20 Dec 2019
- Results posted
- No
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.
PubMed 10086437Evans 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.
PubMed 16430321Stryker 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.
PubMed 18702002
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Message Testing for Tobacco-Related Corrective Statements
- ClinicalTrials.gov ID
- NCT01282008
- Acronym / sponsor ID
- 999911067
- Conditions
- Tobacco, Smoking, Communication
- Keywords
- Online Surveys, Tobacco Corrective Statements, Message Testing, Focus Groups
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 627 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 21 Jan 2011
- First posted
- 24 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focus Groups | – | –Focus Groups about smoking messages |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Random sample of GfK Web panel participants.@@@@@@
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Knowledge
Time frame: Immediately upon exposure to stimuli
Tobacco-related knowledge, attitudes, and beliefs were measured at baseline and after exposure to message stimuli.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Background: PubMed 10086437Ayanian 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.
- Background: PubMed 16430321Evans 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.
- Background: PubMed 18702002Stryker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly D Blake, D.Sc. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tobacco and Smoking, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge (time frame: Immediately upon exposure to stimuli). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01282008, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.