Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Success & Health Impacts For Transit Drivers During Onboarding (SHIFTOnboard)

1 de febrero de 2023 actualizado por: Ryan Olson, Oregon Health and Science University

SHIFT Onboard: Protecting New Transit Operators Against Safety and Health Hazards

The project is a cluster randomized controlled trial of an occupational health intervention for newly hired bus operators. Transit authorities will be randomized to intervention and usual practice conditions and new bus operators will be recruited to participate in a two year study. Intervention participants will complete a program designed to prevent weight gain while also supporting early adjustment and job success. Control participants will experience standard or usual practice working conditions.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Epidemiological evidence indicates that bus driving is associated with increased risk for obesity and some chronic diseases, and that it is time for interventions. In this regard, the early transition into bus driving has been neglected. Not only are interventions lacking for new employees entering potentially obesogenic occupations, but workplace training and socialization programs for new hires (referred to as onboarding) rarely address potential occupational health hazards.

To address research gaps, investigators will integrate an effective health intervention approach with traditional onboarding programs for new bus drivers. This intervention approach, which was originally developed with commercial truck drivers, was implemented through a mobile friendly website, and tactics included an incentivized game-like competition that was supported with behavior and body weight logging, computer-based training, and motivational interviewing. In a cluster-randomized trial with commercial truck drivers the intervention produced a mean body weight effect of -7.29 lbs (p<.0001; Olson et al, 2016), which is among the strongest results observed globally with occupational drivers.

In the proposed intervention adaptation, the "SHIFT Onboard" intervention (Success & Health Impacts For Transit drivers during Onboarding) will be designed to prevent weight gain among new bus drivers while also supporting early adjustment and job success. The primary hypotheses are that relative to usual practice, SHIFT Onboard participants will have (1) superior energy balance behaviors (sleep, eating, exercise) and (2) less weight gain. Investigators will also evaluate impacts on new employee adjustment and economic outcomes that are critical to employers; the ultimate adopters of occupational health interventions. This project will take place over five years and will accomplish three specific aims:

  1. Adapt proven tactics and pilot SHIFT Onboard with new bus drivers: Through formative research with transit partners and iterative testing with drivers investigators will adapt existing web technology, intervention tactics, and training content for newly hired mass transit bus drivers. The adapted SHIFT Onboard intervention will then be pilot tested with new drivers at a partner transit authority.
  2. Determine the efficacy of SHIFT Onboard for preventing weight gain. Metropolitan transit authorities, stratified by size, will be randomly assigned to intervention or usual practice control conditions. SHIFT Onboard will be implemented with natural groups of bus operators who complete training together during the first year. Primary intervention effectiveness outcomes will be between-groups differences at 1- and 2-year follow-ups in changes in energy balance behaviors (sleep, eating, exercise) and body weight.
  3. Evaluate new employee adjustment and economic impacts of SHIFT Onboard. Investigators will also evaluate intervention impacts on new bus operator adjustment (role stress, confidence, connectedness) and job attitudes (job satisfaction, intention to remain). Economic return on investment calculations will contrast intervention costs relative to savings projected from intervention effects (e.g., health care costs, absenteeism, safety).

Investigators will also collect measures of work demands, stressors, and strains (responses to stressors) at all time points to characterize occupational exposures among the sample, and to explore for possible associations with workers' health outcomes.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

284

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • Oregon Health & Science University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

21 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Hired to work as a transit bus operator at a participating transit authority, and currently in the pre-service training period

Exclusion Criteria:

  • Female participants who are pregnant or become pregnant during the study period will be excluded from body weight related intervention activities and outcome analyses

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Experimental: SHIFT Onboard Intervention
A 12-month onboarding process and social challenge supported with goal setting, computer-based training, self-monitoring, and group motivational interviewing.
A 12-month onboarding process and social challenge supported with goal setting, computer-based training, self-monitoring, and group motivational interviewing.
Sin intervención: Usual Practice Control
Participants experience standard or "Usual Practices" in new employee onboarding processes at their workplace.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline in body weight at 12 and 24 months
Periodo de tiempo: Baseline, 12, and 24 months
Directly measured body weight in kg.
Baseline, 12, and 24 months
Body Mass Index
Periodo de tiempo: Baseline, 12 and 24 months
Calculated from directly measured weight and height (kg/m^2).
Baseline, 12 and 24 months
Change from baseline in percent body fat
Periodo de tiempo: Baseline, 12 and 24 months
Percent body fat measured through bioelectric impedence
Baseline, 12 and 24 months
Change from baseline in self-reported fruit and vegetable intake at 12 and 24 months
Periodo de tiempo: Baseline, 12, and 24 months
Survey measures of fruit and vegetable intake.
Baseline, 12, and 24 months
Change from baseline in self-reported consumption of high fat foods at 12 and 24 months.
Periodo de tiempo: Baseline, 12 and 24 months.
Survey measure of high fat food consumption frequency and portion sizes.
Baseline, 12 and 24 months.
Change from baseline in self-reported sugary food and drink consumption at 12 and 24 months
Periodo de tiempo: Baseline, 12 and 24 months.
Survey measure of the frequency of sugary food and drink consumption.
Baseline, 12 and 24 months.
Change from baseline in self-reported fast food consumption.
Periodo de tiempo: Baseline, 12 and 24 months.
Survey measure of the frequency of fast food consumption.
Baseline, 12 and 24 months.
Change from baseline in self-reported physical activity at 12 and 24 months
Periodo de tiempo: Baseline, 12, and 24 months
Survey measures of daily/weekly physical activity levels.
Baseline, 12, and 24 months
Change from baseline in actigraphically measured physical activity at 12 and 24 months
Periodo de tiempo: Baseline, 12 and 24 months
Actigraphy measures of daily/weekly of physical activity levels.
Baseline, 12 and 24 months
Change from baseline in self-reported sleep quality at 12 and 24 months
Periodo de tiempo: Baseline, 12, and 24 months
Survey measures of typical sleep quality.
Baseline, 12, and 24 months
Change from baseline in self-reported sleep quantity at 12 and 24 months
Periodo de tiempo: Baseline, 12 and 24 months
Survey measures of typical daily sleep time.
Baseline, 12 and 24 months
Change from baseline in actigraphically measured sleep quality at 12 and 24 months
Periodo de tiempo: Baseline, 12 and 24 months
Actigraphy measures of sleep quality as indicated by minutes of Wake After Sleep Onset in main sleep periods.
Baseline, 12 and 24 months
Change from baseline in actigraphically measured sleep quantity at 12 and 24 months
Periodo de tiempo: Baseline, 12 and 24 months
Actigraphy measures of sleep duration in minutes for the daily main sleep period and naps.
Baseline, 12 and 24 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in job role conflict
Periodo de tiempo: Baseline, 12, and 24 months
Survey measures of job role conflict.
Baseline, 12, and 24 months
Changes in perceived acceptance by others
Periodo de tiempo: Baseline, 12 and 24 months
Survey measures of perceived acceptance by others.
Baseline, 12 and 24 months
Changes in job-related self-efficacy
Periodo de tiempo: Baseline, 12 and 24 months
Survey measures of job-related self-efficacy.
Baseline, 12 and 24 months
Changes in job satisfaction
Periodo de tiempo: Baseline, 12 and 24 months
Survey measure of job satisfaction
Baseline, 12 and 24 months
Changes in intention to remain at job
Periodo de tiempo: Baseline, 12 and 24 months
Survey measures of intention to remain.
Baseline, 12 and 24 months
Economic cost-benefit factors
Periodo de tiempo: 12 month intervention costs, and a target minimum of four years of corporate data for each agency (2 historical, 2 during study period)
Intervention costs (e.g., participant wages, fees for group facilitators, cost of resources/tech support, intervention incentives) will be contrasted with estimated savings (e.g., estimates of health care cost savings based on weight changes, and estimates of costs/savings utilizing corporate data for study participants on absenteeism, job turnover, bus collisions, driver injuries and workers' compensation claims, and passenger/pedestrian/other driver injuries).
12 month intervention costs, and a target minimum of four years of corporate data for each agency (2 historical, 2 during study period)
Absenteeism
Periodo de tiempo: Baseline, 12 and 24 months
Organizational records of absenteeism for new bus operators
Baseline, 12 and 24 months
Job turnover
Periodo de tiempo: Baseline, 12 and 24 months
Organizational records of job turnover among new bus operators
Baseline, 12 and 24 months
Bus collisions
Periodo de tiempo: Baseline, 12 and 24 months
Organizational records of bus collisions among new bus operators
Baseline, 12 and 24 months
Injuries
Periodo de tiempo: Baseline, 12 and 24 months
Organizational records of bus operator and passenger injuries
Baseline, 12 and 24 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Baseline body weight as a moderator of intervention effects on weight at follow-ups
Periodo de tiempo: Baseline, 12, and 24 months
Baseline body weight evaluated as a moderator of intervention effects at 12 and 24 months.
Baseline, 12, and 24 months
Change from baseline in blood pressure at 12 and 24 months
Periodo de tiempo: Baseline, 12, and 24 months
Direct measurement in mmHg.
Baseline, 12, and 24 months
Change from baseline in triglycerides
Periodo de tiempo: Baseline, 12, and 24 months
Direct measurement of triglycerides via Cholestech LDX Analyzer in mg/dL.
Baseline, 12, and 24 months
Change from baseline in Hemoglobin A1c at 12 and 24 months
Periodo de tiempo: Baseline, 12, and 24 months
HbA1c measured via fingerprick blood sample.
Baseline, 12, and 24 months
Change from baseline in Total cholesterol
Periodo de tiempo: Baseline, 12, and 24 months
Total cholesterol measured from fingerstick blood sample via Cholestech LDX Analyzer in mg/dL.
Baseline, 12, and 24 months
Change from baseline in HDL cholesterol
Periodo de tiempo: Baseline, 12 and 24 months
HDL measured from fingerstick blood sample via Cholestech LDX Analyzer in mg/dL.
Baseline, 12 and 24 months
Change from baseline in LDL cholesterol
Periodo de tiempo: Baseline, 12 and 24 months
LDL measured from fingerstick blood sample via Cholestech LDX Analyzer in mg/dL.
Baseline, 12 and 24 months
Change from baseline in the LDL/HDL cholesterol ratio
Periodo de tiempo: Baseline, 12, and 24 months
LDL/HDL cholesterol ratio computed from values measured via Cholestech LDX Analyzer in mg/dL
Baseline, 12, and 24 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Ryan Olson, PhD, Oregon Health and Science University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de julio de 2019

Finalización primaria (Anticipado)

31 de julio de 2023

Finalización del estudio (Anticipado)

31 de julio de 2023

Fechas de registro del estudio

Enviado por primera vez

30 de octubre de 2018

Primero enviado que cumplió con los criterios de control de calidad

1 de noviembre de 2018

Publicado por primera vez (Actual)

5 de noviembre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de febrero de 2023

Última actualización enviada que cumplió con los criterios de control de calidad

1 de febrero de 2023

Última verificación

1 de febrero de 2023

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 3061
  • 2R01HL105495-06A1 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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 SHIFT Onboard Intervention

3
Suscribir