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Healthy SubjectNCT03457480

Text Messages in Preventing Tobacco Use in Young Adults

A study testing Computer-Assisted Intervention, Focus Group and Informational Intervention in people with Healthy Subject, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subject
What is being tested?
Computer-Assisted Intervention, Focus Group and Informational Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
781 participants
Where
1 siteUnited States
Study dates
20 Sep 2013to 29 Jan 2021
Phase
Interventional
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 18 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • -Currently a smoker (Phase 3)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Informing and Correcting Perceptions Regarding Tobacco Products Among Young Adults

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:

  1. 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:

  1. 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.

Conditions
Healthy Subject
Being tested
Computer-Assisted Intervention, Focus Group, Informational Intervention, Survey Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computer-Assisted InterventionOther

    Read computer messages

  • Focus GroupBehavioural

    Attend focus group

  • Informational InterventionOther

    Receive text messages

  • Survey AdministrationOther

    Complete surveys about experience

Study groups in NCT03457480
Study groupRoleWhat they receive
Prevention (text messages, computer messages)ExperimentalPHASE 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.
Receives: Other: Computer-Assisted Intervention; Behavioral: Focus Group; Other: Informational Intervention; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Up to 8 months

Secondary outcomes (1)

  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.

    Measured: Up to 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2018
  2. Study start20 Sep 2013
  3. Primary completion29 Jan 2021
  4. Study completion29 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
781 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03457480
Sponsor's protocol ID
2013-0474
Other IDs
NCI-2018-01277, 2013-0474, P50CA180906
Status last verified
Jan 2021
First submitted
28 Feb 2018
Last updated
2 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Computer-Assisted Intervention, Focus Group and Informational Intervention in people with Healthy Subject, run by M.D. Anderson Cancer Center 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 8 inclusion and 1 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 2 Feb 2021. 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?

Baseline knowledge and risk perceptions of Tobacco Use Questionnaire (time frame: Up to 8 months). The study lists 4 primary outcomes in all. 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 NCT03457480, which also lists 2 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 2 Feb 2021.

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