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CompletedNCT03457480Updated Feb 2, 2021

Text Messages in Preventing Tobacco Use in Young Adults

An interventional study of Computer-Assisted Intervention and Focus Group in Healthy Subject, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-02.

Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
781
Allocation
Not applicable
Ages
18 Years to 25 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Healthy Subject
03

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

-Currently a smoker (Phase 3)

04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
781 participants (actual)

Study arms

  • Experimental
    Prevention (text messages, computer messages)

    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.

    Other: Computer-Assisted Intervention · Behavioral: Focus Group · Other: Informational Intervention · Other: Survey Administration

Interventions

  • OtherComputer-Assisted Intervention

    Read computer messages

  • BehavioralFocus Group

    Attend focus group

  • OtherInformational Intervention

    Receive text messages

  • OtherSurvey Administration

    Complete surveys about experience

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 8 months

  2. 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.

    Time frame: Up to 8 months

  3. 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.

    Time frame: Up to 8 months

  4. 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.

    Time frame: Up to 8 months

Secondary outcomes

  1. 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.

    Time frame: Up to 8 months

06

Study locations

1 site
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
07

References and documents

Publications

  • Prokhorov AV, Calabro KS, Arya A, Russell S, Czerniak KW, Botello GC, Chen M, Yuan Y, Perez A, Vidrine DJ, Perry CL, Khalil GE. Mobile Text Messaging for Tobacco Risk Communication Among Young Adult Community College Students: Randomized Trial of Project Debunk. JMIR Mhealth Uhealth. 2021 Nov 24;9(11):e25618. doi: 10.2196/25618. PubMed 34822339 ↗
  • Prokhorov AV, Khalil GE, Calabro KS, Machado TC, Russell S, Czerniak KW, Botello GC, Chen M, Perez A, Vidrine DJ, Perry CL. Mobile Phone Text Messaging for Tobacco Risk Communication Among Young Adult Community College Students: Protocol and Baseline Overview for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Oct 15;7(10):e10977. doi: 10.2196/10977. PubMed 30322833 ↗
08

Registry details

Key details

Study ID
NCT03457480
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Mar 7, 2018
Start date
Sep 20, 2013
Primary completion
Jan 29, 2021
Completion
Jan 29, 2021
Last update
Feb 2, 2021

Study contacts

Alexander V Prokhorov
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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