- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03457480
Text Messages in Preventing Tobacco Use in Young Adults
Informing and Correcting Perceptions Regarding Tobacco Products Among Young Adults
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
Attend focus group
Read computer messages
Receive text messages
Complete surveys about experience
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline knowledge and risk perceptions of Tobacco Use Questionnaire
Time Frame: Up to 8 months
|
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
Time Frame: Up to 8 months
|
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
Time Frame: Up to 8 months
|
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
Time Frame: Up to 8 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk perceptions related to tobacco products Questionnaire
Time Frame: Up to 8 months
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alexander V Prokhorov, M.D. Anderson Cancer Center
Publications and helpful links
General 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2013-0474 (Other Identifier: M D Anderson Cancer Center)
- NCI-2018-01277 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- P50CA180906 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Subject
-
Changchun GeneScience Pharmaceutical Co., Ltd.Completed
-
CelltrionCompletedHealthy SubjectKorea, Republic of
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)Active, not recruiting
-
Staidson (Beijing) Biopharmaceuticals Co., LtdCompleted
-
GeneScience Pharmaceuticals Co., Ltd.Completed
-
Kyowa Kirin Co., Ltd.Completed
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingHealthy SubjectUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI); Texas A&M UniversityCompletedHealthy SubjectUnited States
-
Whanin Pharmaceutical CompanyCompletedHealthy SubjectKorea, Republic of
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); National Heart, Lung, and Blood Institute...Active, not recruitingHealthy SubjectUnited States
Clinical Trials on Focus Group
-
Queen's University, BelfastCompletedAge Related Macular DegenerationUnited Kingdom
-
M.D. Anderson Cancer CenterCompletedPediatric CancersUnited States
-
Stanford UniversityNational Institute of Mental Health (NIMH)Completed
-
Teesside UniversitySouth Tees Hospitals NHS Foundation TrustNot yet recruitingOveractive Bladder | Urinary Incontinence | Benign Prostatic Hyperplasia | Urinary Tract Infections | Urinary Retention | Underactive Bladder
-
University of Kansas Medical CenterEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedPregnancy RelatedUnited States
-
Beth FosterThe Hospital for Sick Children; University of Pittsburgh; Seattle Children's... and other collaboratorsCompletedTeen Adherence in KidnEy Transplant, Improving Tracking To Optimize Outcomes (Stage 1) (TAKE-IT TOO)Medication AdherenceCanada, United States
-
University of North Carolina, Chapel HillCompletedAcquired Immunodeficiency Syndrome
-
Sunnybrook Health Sciences CentreWithdrawnFocus of Study is on Dentist's Attitudes Toward BP MeasuresCanada
-
Oregon Health and Science UniversityRecruitingAttention Deficit/Hyperactivity Disorder | Irritable Mood | Emotional DysfunctionUnited States
-
University of Colorado, DenverRecruiting