NCT03457480

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
781

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 20, 2013

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2021

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

7.4 years

First QC Date

February 28, 2018

Last Update Submit

January 29, 2021

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • Risk perceptions related to tobacco products Questionnaire

    Up to 8 months

Study Arms (1)

Prevention (text messages, computer messages)

EXPERIMENTAL

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 InterventionBehavioral: Focus GroupOther: Informational InterventionOther: Survey Administration

Interventions

Computer-Assisted InterventionOTHER

Read computer messages

Prevention (text messages, computer messages)
Focus GroupBEHAVIORAL

Attend focus group

Prevention (text messages, computer messages)
Informational InterventionOTHER

Receive text messages

Prevention (text messages, computer messages)
Survey AdministrationOTHER

Complete surveys about experience

Prevention (text messages, computer messages)

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Currently a smoker (Phase 3)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • 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.

    PMID: 34822339DERIVED

  • 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.

    PMID: 30322833DERIVED

Related Links

MeSH Terms

Interventions

Focus Groups

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Alexander V Prokhorov

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 7, 2018

Study Start

September 20, 2013

Primary Completion

January 29, 2021

Study Completion

January 29, 2021

Last Updated

February 2, 2021

Record last verified: 2021-01

Locations

US(1)