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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03457480
Other study ID # 2013-0474
Secondary ID NCI-2018-0127720
Status Completed
Phase N/A
First received
Last updated
Start date September 20, 2013
Est. completion date January 29, 2021

Study information

Verified date January 2021
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial studies how well text messages work in preventing tobacco use in young adults. Text messaging may help to teach young adults about the risks of tobacco products.


Description:

PRIMARY OBJECTIVES: I. To assess baseline knowledge and risk perceptions about the use of conventional and new and emerging tobacco products among a subset of community college students from the two participating Houston Community College (HCC) campuses (Central and Coleman campuses). (Phase 1.1) II. Test the text messages with university students enrolled in the health communications academic programs. (Phase 1.2) III. Assess the awareness, attitudes, receptivity, and comprehension of the harmful effects of conventional and new and emerging tobacco products among young adults. (Phase 2) IV. Identify the most effective combinations of text message framing for communicating information about the potential harmful effects of tobacco products to young adults. (Phase 2) V. To obtain an objective measure of the psychological (i.e., emotional and cognitive) effect of the messages on young adults. (Phase 3) EXPLORATORY OBJECTIVES: I. Define and analyze key moderators of young adult awareness, attitudes, receptivity, and understanding of the harmful risks and constituents of conventional, new and emerging tobacco products. (Phase 2) OUTLINE: PHASE I: Participants attend focus group over 2 hours. PHASE II: Participants receive 2 text messages per day for 30 days at baseline and after 3 months. PHASE III: Participants read 64 computer messages with or without images over 30 minutes and have their facial expressions assessed.


Recruitment information / eligibility

Status Completed
Enrollment 781
Est. completion date January 29, 2021
Est. primary completion date January 29, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - Age 18-25 (Phase 1, Phase 2, Phase 3) - Attend classes at either Houston Community College (HCC) Central Campus or Coleman Campus (Phase 1 and Phase 2), Spring Branch Campus (Phase 2) or the University of Houston (Phase 3) - Own a smartphone capable of receiving texts from the study's text messaging ) resource (Phase 1, Phase 2 and Phase 3) - Use phone text-messaging features on a regular basis (Phase 1, Phase 2, Phase 3) - Provide cell phone number (Phase 1, Phase 2, Phase 3) - Speak and read English (Phase 1, Phase 2, Phase 3) - Enrolled in a communication program (Phase 1, health communication student review) - Evidence of smoking susceptibility as defined by the Smoking Susceptibility Scale (Phase 3) Exclusion Criteria: -Currently a smoker (Phase 3)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Computer-Assisted Intervention
Read computer messages
Behavioral:
Focus Group
Attend focus group
Other:
Informational Intervention
Receive text messages
Survey Administration
Complete surveys about experience

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Baseline knowledge and risk perceptions of Tobacco Use Questionnaire Participants will take baseline knowledge and risk perceptions about the use of conventional and new and emerging tobacco products among a subset of community college students from the two participating Houston Community College (HCC) campuses (Central and Coleman campuses) Knowledge about whether products contain nicotine scale Yes or No (0-1) A higher score indicates higher knowledge Risk perception for using tobacco products scale from( 1-5) A higher score indicates a higher perception of risk of harm. No scale being used. Up to 8 months
Primary Focus Groups Questionnaire No scale being used. Participants will take part in use of text messages within the university students enrolled in the health communications academic programs. Students will review and rate the messages with the goal of achieving 70% agreement among students across each text message. No scale will be used. Up to 8 months
Primary Perceived Risk Perception changes amongst young adults Questionnaire Participants will show the awareness, attitudes, receptivity, and comprehension of the harmful effects of conventional and new and emerging tobacco products among young adults. 4-point Likert Scale. Higher scores will endorse beliefs for greater benefits of electronic cigarette use. 3-point Likert scale higher score endorse greater addictiveness. Risk perception for using tobacco products. Response format 1-5. A higher score indicates a higher perception of risk of harm. No scale being used. Up to 8 months
Primary Information seeking and avoidance about tobacco products Questionnaire Participants will identify the most effective combinations of text message framing for communicating information about the potential harmful effects of tobacco products to young adults. Risk perception for using tobacco products. Response format 1-5. A Higher score indicates a higher perception of risk of harm. No scale being used. Up to 8 months
Secondary Risk perceptions related to tobacco products Questionnaire Participants will have the two-way interactions for synergistic effects on perceived risk for young adults after post 3 month follow up used for determining high and low risk perceptions. Risk perception for using tobacco products. Response format 1-5. A higher score indicates a higher perception of risk of harm. No scale being used. Up to 8 months
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