NCT00684437

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. 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. 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.
  3. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
494

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 22, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 26, 2008

Completed
18 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

18 years

First QC Date

May 22, 2008

Last Update Submit

January 13, 2026

Conditions

Keywords

Health LiteracySmoking RiskFocus GroupQuestionnaireSurvey

Outcome Measures

Primary Outcomes (1)

  • Factors that may influence how smokers understand smoking health risk informational messages.

    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

    2 years

Study Arms (4)

Factual Gain-Framed

EXPERIMENTAL

Smoking Risk Message - Factual Gain-Framed (FGF)

Behavioral: Focus GroupBehavioral: Questionnaire

Factual Loss-Framed

EXPERIMENTAL

Smoking Risk Message - Factual Loss-Framed (FLF)

Behavioral: Focus GroupBehavioral: Questionnaire

Emotional Gain-Framed

EXPERIMENTAL

Smoking Risk Message - Emotional Gain-Framed (EGF)

Behavioral: Focus GroupBehavioral: Questionnaire

Emotional Loss-Framed

EXPERIMENTAL

Smoking Risk Message - Emotional Loss-Framed (ELF)

Behavioral: Focus GroupBehavioral: Questionnaire

Interventions

Focus GroupBEHAVIORAL

Focus group discussion and evaluation of various smoking risk informational messages. The focus group session should last about 1 hour and 30 minutes.

Emotional Gain-FramedEmotional Loss-FramedFactual Gain-FramedFactual Loss-Framed
QuestionnaireBEHAVIORAL

Questionnaires taking 15-30 minutes to complete.

Also known as: Survey
Emotional Gain-FramedEmotional Loss-FramedFactual Gain-FramedFactual Loss-Framed

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • current use of nicotine replacement therapy or bupropion
  • current enrollment in a smoking cessation treatment program
  • expired CO\<10 ppm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Smoking

Interventions

Focus GroupsSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Lorna H. McNeill, MPH,PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2008

First Posted

May 26, 2008

Study Start

May 21, 2008

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations