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Literacy and Smoking Risk Communications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00684437
Recruitment Status : Active, not recruiting
First Posted : May 26, 2008
Last Update Posted : October 5, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Objectives:

Smokers with varying levels of health literacy as assessed by the S-TOFHLA (i.e., inadequate, marginal, adequate) recruited from the community will listen to one of 4 different types of messages emphasizing the health consequences of smoking recorded on a computer in the form of audio scripts (i.e., a human voice pre-recorded on a computer will read each message). Messages written at a 5th to 6th grade reading level will be concurrently presented in written form via a computer monitor and be manipulated in terms of 1) emotionality (i.e., primarily fact- vs. primarily emotion-based), and 2) framing (i.e., gain-framed messages that highlight the potential benefits of quitting smoking vs. loss-framed messages that emphasize the potential costs of failing to quit smoking). Emotionality and framing will be completely crossed to create four different types of messages, 1) factual gain-framed (FGF), 2) factual loss-framed (FLF), 3) emotional gain-framed (EGF), and 4) emotional loss-framed (ELF).

The primary objectives are to:

  1. Examine whether main effects emerge for health literacy as assessed by the S-TOFHLA (inadequate, marginal, adequate) and the different message types (fact- vs. emotion-based and gain- vs. loss-framed) on the primary explicit and implicit outcomes: a) intention to quit, and b) implicit and explicit attitudes toward smoking.
  2. Examine whether health literacy interacts with the different types of messages (fact-based vs. emotion-based and gain-framed vs. loss-framed) to influence the primary explicit and implicit outcome measures: a) intention to quit smoking, and b) implicit and explicit attitudes toward smoking.

    A secondary, exploratory aim is to:

  3. Examine potential associations between a) the primary explicit and implicit outcomes, and b) the secondary explicit and implicit outcomes: knowledge, risk perception, attitudes, self-efficacy, message evaluations, implicit fear of disease, and implicit associations between smoking and disease.

Condition or disease Intervention/treatment
Smoking Behavioral: Focus Group Behavioral: Questionnaire

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 495 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Literacy and Smoking Risk Communications
Actual Study Start Date : May 2008
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Factual Gain-Framed
Smoking Risk Message - Factual Gain-Framed (FGF)
Behavioral: Focus Group
Focus group discussion and evaluation of various smoking risk informational messages. The focus group session should last about 1 hour and 30 minutes.
Behavioral: Questionnaire
Questionnaires taking 15-30 minutes to complete.
Other Name: Survey
Experimental: Factual Loss-Framed
Smoking Risk Message - Factual Loss-Framed (FLF)
Behavioral: Focus Group
Focus group discussion and evaluation of various smoking risk informational messages. The focus group session should last about 1 hour and 30 minutes.
Behavioral: Questionnaire
Questionnaires taking 15-30 minutes to complete.
Other Name: Survey
Experimental: Emotional Gain-Framed
Smoking Risk Message - Emotional Gain-Framed (EGF)
Behavioral: Focus Group
Focus group discussion and evaluation of various smoking risk informational messages. The focus group session should last about 1 hour and 30 minutes.
Behavioral: Questionnaire
Questionnaires taking 15-30 minutes to complete.
Other Name: Survey
Experimental: Emotional Loss-Framed
Smoking Risk Message - Emotional Loss-Framed (ELF)
Behavioral: Focus Group
Focus group discussion and evaluation of various smoking risk informational messages. The focus group session should last about 1 hour and 30 minutes.
Behavioral: Questionnaire
Questionnaires taking 15-30 minutes to complete.
Other Name: Survey


Outcome Measures

Primary Outcome Measures :
  1. Factors that may influence how smokers understand smoking health risk informational messages. [ Time Frame: 2 years ]
    Examine whether main effects emerge for health literacy as assessed by the Short Test of Functional Health Literacy in Adults (S-TOFHLA) (inadequate, marginal, adequate) and the different message types (fact- vs. emotion-based and gain- vs. loss-framed) on the primary explicit and implicit outcomes: a) intention to quit, and b) implicit and explicit attitudes toward smoking


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. age 18 to 70 years
  2. current smoker with a history of at least 5 cigarettes/day for the last year
  3. can speak, read, and write in English
  4. home address and a functioning home telephone number

Exclusion Criteria:

  1. current use of nicotine replacement therapy or bupropion
  2. current enrollment in a smoking cessation treatment program
  3. expired CO<10 ppm
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684437


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Lorna H. McNeill, PHD, MPH M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00684437     History of Changes
Other Study ID Numbers: 2006-0699
1R01CA125413-01 ( U.S. NIH Grant/Contract )
NCI-2015-00727 ( Registry Identifier: NCI-CTRP )
First Posted: May 26, 2008    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017

Keywords provided by M.D. Anderson Cancer Center:
Health Literacy
Smoking Risk
Focus Group
Questionnaire
Survey