- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03730792
Success & Health Impacts For Transit Drivers During Onboarding (SHIFTOnboard)
SHIFT Onboard: Protecting New Transit Operators Against Safety and Health Hazards
Descripción general del estudio
Estado
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:
- 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.
- 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.
- 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
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health & Science University
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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:
- 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
¿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.
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A 12-month onboarding process and social challenge supported with goal setting, computer-based training, self-monitoring, and group motivational interviewing.
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Sin intervención: Usual Practice Control
Participants experience standard or "Usual Practices" in new employee onboarding processes at their workplace.
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¿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
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Directly measured body weight in kg.
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Baseline, 12, and 24 months
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Body Mass Index
Periodo de tiempo: Baseline, 12 and 24 months
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Calculated from directly measured weight and height (kg/m^2).
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Baseline, 12 and 24 months
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Change from baseline in percent body fat
Periodo de tiempo: Baseline, 12 and 24 months
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Percent body fat measured through bioelectric impedence
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Baseline, 12 and 24 months
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Change from baseline in self-reported fruit and vegetable intake at 12 and 24 months
Periodo de tiempo: Baseline, 12, and 24 months
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Survey measures of fruit and vegetable intake.
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Baseline, 12, and 24 months
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Change from baseline in self-reported consumption of high fat foods at 12 and 24 months.
Periodo de tiempo: Baseline, 12 and 24 months.
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Survey measure of high fat food consumption frequency and portion sizes.
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Baseline, 12 and 24 months.
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Change from baseline in self-reported sugary food and drink consumption at 12 and 24 months
Periodo de tiempo: Baseline, 12 and 24 months.
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Survey measure of the frequency of sugary food and drink consumption.
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Baseline, 12 and 24 months.
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Change from baseline in self-reported fast food consumption.
Periodo de tiempo: Baseline, 12 and 24 months.
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Survey measure of the frequency of fast food consumption.
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Baseline, 12 and 24 months.
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Change from baseline in self-reported physical activity at 12 and 24 months
Periodo de tiempo: Baseline, 12, and 24 months
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Survey measures of daily/weekly physical activity levels.
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Baseline, 12, and 24 months
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Change from baseline in actigraphically measured physical activity at 12 and 24 months
Periodo de tiempo: Baseline, 12 and 24 months
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Actigraphy measures of daily/weekly of physical activity levels.
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Baseline, 12 and 24 months
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Change from baseline in self-reported sleep quality at 12 and 24 months
Periodo de tiempo: Baseline, 12, and 24 months
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Survey measures of typical sleep quality.
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Baseline, 12, and 24 months
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Change from baseline in self-reported sleep quantity at 12 and 24 months
Periodo de tiempo: Baseline, 12 and 24 months
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Survey measures of typical daily sleep time.
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Baseline, 12 and 24 months
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Change from baseline in actigraphically measured sleep quality at 12 and 24 months
Periodo de tiempo: Baseline, 12 and 24 months
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Actigraphy measures of sleep quality as indicated by minutes of Wake After Sleep Onset in main sleep periods.
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Baseline, 12 and 24 months
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Change from baseline in actigraphically measured sleep quantity at 12 and 24 months
Periodo de tiempo: Baseline, 12 and 24 months
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Actigraphy measures of sleep duration in minutes for the daily main sleep period and naps.
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Baseline, 12 and 24 months
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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
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Survey measures of job role conflict.
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Baseline, 12, and 24 months
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Changes in perceived acceptance by others
Periodo de tiempo: Baseline, 12 and 24 months
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Survey measures of perceived acceptance by others.
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Baseline, 12 and 24 months
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Changes in job-related self-efficacy
Periodo de tiempo: Baseline, 12 and 24 months
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Survey measures of job-related self-efficacy.
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Baseline, 12 and 24 months
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Changes in job satisfaction
Periodo de tiempo: Baseline, 12 and 24 months
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Survey measure of job satisfaction
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Baseline, 12 and 24 months
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Changes in intention to remain at job
Periodo de tiempo: Baseline, 12 and 24 months
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Survey measures of intention to remain.
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Baseline, 12 and 24 months
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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)
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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).
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12 month intervention costs, and a target minimum of four years of corporate data for each agency (2 historical, 2 during study period)
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Absenteeism
Periodo de tiempo: Baseline, 12 and 24 months
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Organizational records of absenteeism for new bus operators
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Baseline, 12 and 24 months
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Job turnover
Periodo de tiempo: Baseline, 12 and 24 months
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Organizational records of job turnover among new bus operators
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Baseline, 12 and 24 months
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Bus collisions
Periodo de tiempo: Baseline, 12 and 24 months
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Organizational records of bus collisions among new bus operators
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Baseline, 12 and 24 months
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Injuries
Periodo de tiempo: Baseline, 12 and 24 months
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Organizational records of bus operator and passenger injuries
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Baseline, 12 and 24 months
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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
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Baseline body weight evaluated as a moderator of intervention effects at 12 and 24 months.
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Baseline, 12, and 24 months
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Change from baseline in blood pressure at 12 and 24 months
Periodo de tiempo: Baseline, 12, and 24 months
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Direct measurement in mmHg.
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Baseline, 12, and 24 months
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Change from baseline in triglycerides
Periodo de tiempo: Baseline, 12, and 24 months
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Direct measurement of triglycerides via Cholestech LDX Analyzer in mg/dL.
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Baseline, 12, and 24 months
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Change from baseline in Hemoglobin A1c at 12 and 24 months
Periodo de tiempo: Baseline, 12, and 24 months
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HbA1c measured via fingerprick blood sample.
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Baseline, 12, and 24 months
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Change from baseline in Total cholesterol
Periodo de tiempo: Baseline, 12, and 24 months
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Total cholesterol measured from fingerstick blood sample via Cholestech LDX Analyzer in mg/dL.
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Baseline, 12, and 24 months
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Change from baseline in HDL cholesterol
Periodo de tiempo: Baseline, 12 and 24 months
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HDL measured from fingerstick blood sample via Cholestech LDX Analyzer in mg/dL.
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Baseline, 12 and 24 months
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Change from baseline in LDL cholesterol
Periodo de tiempo: Baseline, 12 and 24 months
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LDL measured from fingerstick blood sample via Cholestech LDX Analyzer in mg/dL.
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Baseline, 12 and 24 months
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Change from baseline in the LDL/HDL cholesterol ratio
Periodo de tiempo: Baseline, 12, and 24 months
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LDL/HDL cholesterol ratio computed from values measured via Cholestech LDX Analyzer in mg/dL
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Baseline, 12, and 24 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ryan Olson, PhD, Oregon Health and Science University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Palabras clave
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)?
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 SHIFT Onboard Intervention
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University of OxfordOxford University Hospitals NHS TrustDesconocidoSíntomas de comportamientoReino Unido
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Munich Municipal HospitalTechnical University of Munich; University of RegensburgDesconocido
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Shiraz University of Medical SciencesTerminado
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Heidelberg UniversityDesconocidoRetraso de idioma | Trastornos del desarrollo del lenguajeAlemania
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Royal Brompton & Harefield NHS Foundation TrustUniversity of Oxford; National Institute for Health Research, United KingdomTerminadoApnea del Sueño Obstructiva | Apnea posicional del sueñoReino Unido
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Ottawa Heart Institute Research CorporationCanadian Institutes of Health Research (CIHR)Activo, no reclutandoDependencia a la nicotina, cigarrillos | Abstinencia de nicotinaCanadá
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IWK Health CentreCanadian Institutes of Health Research (CIHR)TerminadoTrastorno de oposición desafiante | Trastorno de conductaCanadá
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The Hospital for Sick ChildrenTerminadoObesidad infantilCanadá
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VA Office of Research and DevelopmentTerminadoTrastornos de Estrés PostraumáticoEstados Unidos
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IWK Health CentreMcGill University; Canadian Institutes of Health Research (CIHR); University of... y otros colaboradoresActivo, no reclutandoTrastornos del neurodesarrollo | Trastornos del ComportamientoCanadá