- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03002883
STAND Community College Tobacco Cessation Trial
Sacramento Taking Action Against Nicotine Dependence (STAND) at Sacramento City College
Community colleges have 45% of the nation's undergraduates and have a higher smoking prevalence rate than 4-year colleges. California's community colleges comprise the nation's largest higher education system, and Sacramento has the second largest community college district. As more colleges are encouraged to become smoke and tobacco-free campuses, smokers enrolled at community college campuses need greater support. However, community colleges may lack the student health clinic resources that 4-year colleges have for students who live on campus. Little evidence to date demonstrates effective interventions for smokers on community college campuses.
This pilot study seeks to demonstrate the feasibility and promising outcomes of two cessation interventions, compared with usual care on a community college campus. The first intervention was based on a promising model of brief motivational interviewing delivered by peer educators, developed by the community lead Breathe California of Sacramento-Emigrant Trails (BCSET) through the Sacramento Taking Action Against Tobacco Dependence (STAND) project. The second intervention was based on direct enrollment into the California Smokers' Helpline, which has demonstrated utility for promoting smoking cessation among young adults with low socioeconomic status. Usual care consisted of students going to the student health center for smoking cessation assistance.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- adult 18 years or older
- current smoker in the past 30 days
- smoker wants to quit
- smoker not currently participating in other smoking cessation activities, and
- smoker must be willing to accept randomization into any of the 3 study arms
Exclusion Criteria:
- students not proficient in communicating in English
- adults unable to consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: Usual Care
Students referred to student health for tobacco cessation resources including campus "Quit Kits"
|
Participant provided "Quit Kit" water bottle with small cessation aids (eg.
sunflower seeds) and educated about student health as a cessation resource
|
Comparador activo: Brief Motivational Interviewing
Students received brief motivational interviewing by a student peer educator about tobacco cessation
|
Participant provided "Quit Kit" water bottle with small cessation aids (eg.
sunflower seeds) and educated about student health as a cessation resource
Peer educator conducts brief motivational interviewing about smoking cessation and participant goals
|
Comparador activo: Direct referral to quitline
Students were directly referred to the state quitline for follow-up counseling
|
Participant provided "Quit Kit" water bottle with small cessation aids (eg.
sunflower seeds) and educated about student health as a cessation resource
Peer educator educates about state quitline services and gets verbal consent to use quitline's direct referral web portal for quitline to contact participant in 1-2 business days about free counseling services to make a quit plan
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Biochemically validated smoking cessation
Periodo de tiempo: 6 months
|
Point prevalence abstinence validated by saliva cotinine level
|
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Self-reported smoking cessation
Periodo de tiempo: 6 months
|
Point prevalence abstinence by self-report on survey
|
6 months
|
Self-reported smoking cessation
Periodo de tiempo: 3 months
|
Point prevalence abstinence by self-report on survey
|
3 months
|
Self-reported smoking cessation
Periodo de tiempo: 1 month
|
Point prevalence abstinence by self-report on survey
|
1 month
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Elisa Tong, MD, University of California, Davis
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
- 491744
- 22BT-0057 (Otro identificador: Other)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .
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