- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03457480
Text Messages in Preventing Tobacco Use in Young Adults
Informing and Correcting Perceptions Regarding Tobacco Products Among Young Adults
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Texas
-
Houston, Texas, Estados Unidos, 77030
- M D Anderson Cancer Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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. |
Asistir al grupo de enfoque
Read computer messages
Receive text messages
Complete surveys about experience
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Baseline knowledge and risk perceptions of Tobacco Use Questionnaire
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Risk perceptions related to tobacco products Questionnaire
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Alexander V Prokhorov, M.D. Anderson Cancer Center
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 2013-0474 (Otro identificador: M D Anderson Cancer Center)
- NCI-2018-01277 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- P50CA180906 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Grupo de enfoque
-
Gerencia de Atención Primaria, MadridInstituto de Investigación Sanitaria Gregorio Marañón; Fundacio d'Investigacio... y otros colaboradoresInscripción por invitación
-
Weill Medical College of Cornell UniversityTerminadoConsentimiento informado entregado en tableta | Consentimiento informado en papelEstados Unidos
-
University of WashingtonReclutamientoTrastorno del espectro esquizofrénicoGhana
-
University of MichiganNational Cancer Institute (NCI); Wayne State University; Barbara Ann Karmanos Cancer... y otros colaboradoresTerminadoCáncer de mama | Cáncer colonrectal | Cáncer de pulmón | Cancer de prostataEstados Unidos
-
Umeå UniversityAún no reclutandoFracturas de cadera | Anestesia | Inestabilidad hemodinámica | Ecocardiografía | Evaluación de riesgos
-
Herbolab India Pvt. Ltd.Aún no reclutandoEstrés | Ansiedad | Estuporoso
-
Saglik Bilimleri UniversitesiAún no reclutandoEfecto de la reflexología en los síntomas del síndrome premenstrual
-
University of California, Los AngelesEunice Kennedy Shriver National Institute of Child Health and Human Development...TerminadoDepresión | Estrés Psicológico | Trastornos de Estrés, Traumáticos | Ansiedad | Relaciones entre padres e hijos | Crianza de los hijos | Estrés emocional | Habilidades de afrontamiento | Regulación emocional | Trauma Psicologico | Comportamiento, NiñoEstados Unidos
-
Nantes University HospitalDesconocido
-
University of LisbonAssociacao Protectora dos Diabeticos de PortugalTerminado