- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03457480
Text Messages in Preventing Tobacco Use in Young Adults
Informing and Correcting Perceptions Regarding Tobacco Products Among Young Adults
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Texas
-
Houston, Texas, Förenta staterna, 77030
- M D Anderson Cancer Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
Delta i fokusgrupp
Read computer messages
Receive text messages
Complete surveys about experience
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Baseline knowledge and risk perceptions of Tobacco Use Questionnaire
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Risk perceptions related to tobacco products Questionnaire
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Alexander V Prokhorov, M.D. Anderson Cancer Center
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2013-0474 (Annan identifierare: M D Anderson Cancer Center)
- NCI-2018-01277 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- P50CA180906 (U.S.S. NIH-anslag/kontrakt)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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