- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02098603
Health Protection & Promotion for Oregon Correctional Officers (DOC HEALTH)
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Investigators will enroll up to 100 Correctional Officers from four Oregon Department of Corrections facilities for a randomized controlled 1-year assessment of the intervention. Participants will be evaluated at baseline, 6, and 12 months.
Primary study aims are; 1) Implement a randomized controlled efficacy trial of the Team-centered health promotion intervention, and assess its behavioral and occupational outcomes among COs, 2) Perform a cost analysis to determine the potential economic impact of this CO worksite health promotion program on illness/injury rates and disability claims, and 3) Determine relationships among specific intervention components with changes to behavior and occupational outcomes and assess by mediation analysis.
The intervention involves a scripted peer-taught interactive curriculum, which is delivered as twelve, 30 minute weekly sessions incorporated into a team's usual work time activities. The curriculum is designed to build understanding, healthy decision making skills and engender the social support of teammates; its content and scope reflects the core lifestyles activities used with fire fighters and law enforcement, along with adaptations for the needs of Correctional Officers in domains of the team-building, family support and psychological health.
Participant assessments include established survey instruments, physiological measures and selected laboratory parameters of outcomes and potential mediating variables at the individual, interpersonal and organizational levels. Intervention delivery and fidelity will be assessed. Multilevel and latent growth modeling and mediation analyses will be used to assess outcomes and the relationships among variables. At proposal completion there will be an evidenced-based, exportable occupational safety and health program for COs. Its critical components will be defined, and its benefits clearly determined.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Oregon
-
Portland, Oregon, Estados Unidos, 97239
- Oregon Health and Science University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- security employee of a participating facility in the Oregon Department of Corrections
Exclusion Criteria:
- none
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 |
---|---|
Sin intervención: Solo prueba
|
|
Experimental: Pruebas e Intervención
|
Intervention involves a scripted peer-taught interactive curriculum, which is delivered as twelve, 30 minute weekly sessions incorporated into a team's usual work time or overtime activities.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline in BMI at 6 and 12 months
Periodo de tiempo: Baseline, 6 months, 12 months
|
calculation of direct measurement of height and weight
|
Baseline, 6 months, 12 months
|
Change from baseline in Fruit and Vegetable Intake at 6 and 12 months
Periodo de tiempo: Baseline, 6 months, 12 months
|
questionnaire, NCI fruit/vegetables (Thompson et al., 2002)
|
Baseline, 6 months, 12 months
|
Change from baseline in Physical Activity at 6 and 12 months
Periodo de tiempo: Baseline, 6 months, 12 months
|
questionnaire; Elliot et al., 2007
|
Baseline, 6 months, 12 months
|
Change from baseline in Stress at 6 and 12 months
Periodo de tiempo: Baseline, 6 months, 12 months
|
questionnaire; Netemeyer RG et al, 1996; Cohen et al., 1983; Stanton et al, 2001
|
Baseline, 6 months, 12 months
|
Change from baseline in Sleep at 6 and 12 months
Periodo de tiempo: Baseline, 6 months, 12 months
|
questionnaire; Sorenson et al., 2011; Buysee et al., 1989; Buxton et al.; Rajaratnam et al., 2011
|
Baseline, 6 months, 12 months
|
Change from baseline in Alcohol Use at 6 and 12 months
Periodo de tiempo: Baseline, 6 months, 12 months
|
questionnaire
|
Baseline, 6 months, 12 months
|
Change from baseline in Tobacco Use at 6 and 12 months
Periodo de tiempo: Baseline, 6 months, 12 months
|
questionnaire; study specific development
|
Baseline, 6 months, 12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline in Blood Pressure at 6 and 12 months
Periodo de tiempo: Baseline, 6 months, 12 months
|
direct measurement
|
Baseline, 6 months, 12 months
|
Change from baseline in Percent Body Fat at 6 and 12 months
Periodo de tiempo: Baseline, 6 months, 12 months
|
direct measurement via Bioelectric Impedance Analysis scale
|
Baseline, 6 months, 12 months
|
Change from baseline in Lipids and Lipoproteins at 6 and 12 months
Periodo de tiempo: Baseline, 6 months, 12 months
|
direct measurement via Cholestech LDX analyzer
|
Baseline, 6 months, 12 months
|
Change from baseline in Glucose at 6 and 12 months
Periodo de tiempo: Baseline, 6 months, 12 months
|
direct measurement via Cholestech LDX analyzer
|
Baseline, 6 months, 12 months
|
Cost-Effective Analysis
Periodo de tiempo: 12 months
|
analysis of departmental aggregate data of injury rates and workers compensation claims
|
12 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kerry S Kuehl, MD, DrPH, Oregon Health and Science University
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- e7925
- U19OH010154 (Subvención/contrato del NIH 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. .
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