Quit4Health Intervention in Supporting Smoking Cessation and Preventing Smoking Initiation in Young Adults
Quit4Health: Expanding the Reach of an Innovative Tobacco Control Program for Young Adults
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVES:
I. To evaluate whether smokers randomized to Quit4Health are more likely to quit smoking and remain tobacco-free at 6 months than subjects randomized to the education only control group.
II. To evaluate whether non-smokers who are randomized to Quit4Health are less likely to initiate tobacco usage and remain tobacco-free at 6 months than non-smokers randomized to the education only control group.
SECONDARY OBJECTIVES:
I. To evaluate whether well-established predictors of susceptibility and barriers to cessation (e.g. self-efficacy, knowledge about associated risks, normative beliefs, attitudes, resistance skills, peer pressure) and recently identified predictors of tobacco use (e.g., depression, nicotine dependence, alcohol use, risk-taking propensity) will mediate the effect of the intervention on both onset (for non-smokers) and cessation (for smokers) of tobacco use.
II. To evaluate whether, at the end-of-treatment (EOT) assessment, participants (both smokers and non-smokers) in Quit4Health will report a significantly better perception of Quit4Health (message relevance, tailoring to specific needs based on tobacco use status, motivation to quit, etc.) compared with their counterparts in the education only control arm.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants utilize Quit4Health intervention that includes interactive features, coping strategies and games related to cigarettes and other tobacco products for 1 month.
GROUP II: Participants read an educational booklet about cigarettes and other tobacco products for 1 month.
After completion of study, participants are followed at 3 and 6 months.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Texas
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Houston, Texas, Estados Unidos, 77030
- M D Anderson Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Be enrolled in at least one class at Houston Community College (HCC) Central campus, West Loop campus or Spring Branch campus (cessation and prevention/advocacy groups)
- Speak and read English (cessation and prevention/advocacy groups)
- Own an Android or iOS smartphone (cessation and prevention/advocacy groups)
- Provide current and relevant contact information (cessation and prevention/advocacy groups)
- Smoked at least one cigarette (or more) in the past 30 days (cessation group)
- Have data and wifi capabilities on their mobile device (cessation and prevention/advocacy groups)
- Evidence of smoking susceptibility as defined by the Smoking Susceptibility Scale (prevention/advocacy groups)
Exclusion Criteria:
- People who score 16 or above on the Center for Epidemiologic Studies Depression (CESD) thus showing evidence of major depressive disorder (cessation and prevention/advocacy groups)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: GROUP I (Quit4Health)
Participants utilize Quit4Health intervention that includes interactive features, coping strategies and games related to cigarettes and other tobacco products for 1 month.
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Estudios complementarios
Utilize Quit4Health
Otros nombres:
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Comparador activo: Group II (educational booklet)
Participants read an educational booklet about cigarettes and other tobacco products for 1 month.
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Estudios complementarios
Read educational booklet
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Abstinence from tobacco
Periodo de tiempo: At 6 months
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Any abstinence is defined as "subjective reports of abstinence from tobacco for at least 24 hours or more in the past 30 days", the 7-day point prevalence of abstinence at follow-ups will be verified by measurement of saliva cotinine.
The primary analysis will compare the abstinence rates at 6 months in the control and treatment group using a 2-sample test of proportion for all smokers.
A secondary analysis will involve a simple post-test analysis among smokers using logistic regression.
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At 6 months
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Susceptibility to tobacco initiation
Periodo de tiempo: At 6 months
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Will assess susceptibility to smoking using the measure proposed by Pierce and colleagues.
Will employ similar analytic methods as in primary objective 1 to evaluate the prevalence of susceptibility at the 6-month follow-up in subjects randomized to the experimental intervention condition with respect to subjects assigned to the control condition.
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At 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mediation effect of predictors of smoking and recently identified predictors of tobacco use
Periodo de tiempo: Up to 6 months
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The mediation effect estimate will be computed as the product of the effect of the treatment on the mediators and the mediators on the outcome controlling for the treatment.
The Bayesian mediation analysis method detailed by Yuan and MacKinnon will be used to estimate and make inference on the mediation effect.
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Up to 6 months
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Behavior modification
Periodo de tiempo: Up to 6 months
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Will evaluate the motivational appeal, educational relevance and knowledge acquired in specific modules of the app that lead to behavior modification.
Similar assessments will be done among participants in the control condition with educational materials.
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Up to 6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Alexander V Prokhorov, M.D. Anderson Cancer Center
Publicaciones y enlaces útiles
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
- 2018-0186 (Otro identificador: M D Anderson Cancer Center)
- NCI-2018-03518 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- R42DA035012 (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.
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Ensayos clínicos sobre Administración del Cuestionario
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Washington University School of MedicineTerminadoFilariasis linfatica | Oncocercosis | Infecciones por helmintos transmitidos por el suelo (STH)Liberia