- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01587092
Workstation Pilot Study
WorkStation Pilot Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Eligible participants will be randomized by chance to the WorkStation Intervention Group or to a Usual Working Condition Group.
The WorkStation Intervention Group will be asked to walk for up to 1.5 hours per day during the work week of Monday through Friday on the treadmill. Participants will complete two sessions per day for up to 45 minutes per session, tracking time and speed.
Usual Working Condition Group will be asked to continue working in usual environment and accustomed manner.
Regardless of which group the participants are assigned to, the participants will be asked to complete baseline and follow up assessment visits. Months 3 and 6 for approximately 1 hour for Body measurements (height, weight and waist circumference), body fat percent, gait speed, questionnaires, and accelerometry.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70808
- Pennington Biomedical Research 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:
- Males or females
- BMI ≥ 25 kg/m2
- Willing to give informed consent
- Willing to accept randomization to group assignment and willing to follow the protocol for the group to which they have been assigned
- Willing to maintain fulltime employment at the company for the next 6 months
- Willing to receive frequent contacts and communication from study staff over the next 6 months
Exclusion Criteria:
- Current participation in other Pennington Biomedical research studies
- BMI < 25 kg/m2
- Type 1 diabetes
- Average step count of ≥ 7,500 steps/day
- Self-reporting exercising > 20 minutes on 3 or more days/wk, within the past 6 months
- Unable to walk 45 minutes continuously without taking a rest
- Unable to walk without the use of an assistive device, such as a cane or walker
- Have had a cardiovascular event (stroke or heart attack) in the past 6 months
- Have a pacemaker or any other internal electrical medical device
- Have been diagnosed with Schizophrenia or bipolar disorder
- Have any condition that would limit participation in a physical activity program
- Women who are pregnant, have been pregnant in the last 6 months, or are breastfeeding
- Actively participating in a weight loss program
- Plan to move out of the study area within the next 6 months or plan to be away from work for more than 4 weeks in the next 6 months
- Have another member of household participating in the study
- Have any condition, which, in the opinion of the investigator would impede competence or compliance or possibly hinder completion of the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Usual Working Condition Group
Participants assigned to the usual working condition control group will continue to work in their usual environment and accustomed manner.
The control group participants will have access to the Workstations at the completion of study.
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Participants will be asked to continue working at their desk in their usual manner.
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Comparador activo: WorkStation Intervention Group
Participants will be asked to walk for up to 1.5 hours per day on the treadmill.
This will be split into two 45 minute sessions per day.
Behavioral support will focus on adherence to frequency (attending scheduled sessions).
Participants self-select speed of walking and time (they have up to 45 minutes allotted, but may choose less as they like).
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Participants will be asked to attend 2 scheduled sessions per day of treadmill walking, which will replace their sitting desk time.
Participants will complete 2 sessions per day for 6 months.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Waist
Periodo de tiempo: 6 months
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Waist circumference will decrease in workers assigned to the WorkStation working condition relative to the usual working condition.
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Weight Assessments
Periodo de tiempo: 6 months
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Weight will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
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6 months
|
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Body Fat Percent
Periodo de tiempo: 6 months
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Body fat percent will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
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6 months
|
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Accelerometry
Periodo de tiempo: 6 months
|
Participants' activity level measured by the accelerometer will increase in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
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6 months
|
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Gait Speed
Periodo de tiempo: 6 months
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Participants' gait speed will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
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6 months
|
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Stress
Periodo de tiempo: 6 months
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Participants' stress level will decrease in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
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6 months
|
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Fatigue
Periodo de tiempo: 6 months
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Participants' fatigue level will decrease in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
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6 months
|
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Quality of life Questionnaire
Periodo de tiempo: 6 months
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Participants' quality of life will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
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6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Catrine Tudor-Locke, PhD, Principal Investigator
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
Palabras clave
Otros números de identificación del estudio
- PBRC 12015
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. .