- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03730792
Success & Health Impacts For Transit Drivers During Onboarding (SHIFTOnboard)
SHIFT Onboard: Protecting New Transit Operators Against Safety and Health Hazards
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Oregon
-
Portland, Oregon, Forente stater, 97239
- Oregon Health & Science University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
Ingen inngripen: Usual Practice Control
Participants experience standard or "Usual Practices" in new employee onboarding processes at their workplace.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change from baseline in body weight at 12 and 24 months
Tidsramme: Baseline, 12, and 24 months
|
Directly measured body weight in kg.
|
Baseline, 12, and 24 months
|
Body Mass Index
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Changes in job role conflict
Tidsramme: Baseline, 12, and 24 months
|
Survey measures of job role conflict.
|
Baseline, 12, and 24 months
|
Changes in perceived acceptance by others
Tidsramme: Baseline, 12 and 24 months
|
Survey measures of perceived acceptance by others.
|
Baseline, 12 and 24 months
|
Changes in job-related self-efficacy
Tidsramme: Baseline, 12 and 24 months
|
Survey measures of job-related self-efficacy.
|
Baseline, 12 and 24 months
|
Changes in job satisfaction
Tidsramme: Baseline, 12 and 24 months
|
Survey measure of job satisfaction
|
Baseline, 12 and 24 months
|
Changes in intention to remain at job
Tidsramme: Baseline, 12 and 24 months
|
Survey measures of intention to remain.
|
Baseline, 12 and 24 months
|
Economic cost-benefit factors
Tidsramme: 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
Tidsramme: Baseline, 12 and 24 months
|
Organizational records of absenteeism for new bus operators
|
Baseline, 12 and 24 months
|
Job turnover
Tidsramme: Baseline, 12 and 24 months
|
Organizational records of job turnover among new bus operators
|
Baseline, 12 and 24 months
|
Bus collisions
Tidsramme: Baseline, 12 and 24 months
|
Organizational records of bus collisions among new bus operators
|
Baseline, 12 and 24 months
|
Injuries
Tidsramme: Baseline, 12 and 24 months
|
Organizational records of bus operator and passenger injuries
|
Baseline, 12 and 24 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Baseline body weight as a moderator of intervention effects on weight at follow-ups
Tidsramme: 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
Tidsramme: Baseline, 12, and 24 months
|
Direct measurement in mmHg.
|
Baseline, 12, and 24 months
|
Change from baseline in triglycerides
Tidsramme: 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
Tidsramme: Baseline, 12, and 24 months
|
HbA1c measured via fingerprick blood sample.
|
Baseline, 12, and 24 months
|
Change from baseline in Total cholesterol
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ryan Olson, PhD, Oregon Health and Science University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 3061
- 2R01HL105495-06A1 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på SHIFT Onboard Intervention
-
Mayo ClinicNational Institute on Aging (NIA); University of Minnesota; Georgia Institute...FullførtTrykksår | Trykkskade | RullestolForente stater
-
Changi General HospitalFullført
-
Northwest Institute of Health Sciences, PakistanFullførtKronisk hjerneslagPakistan
-
Peking University Third HospitalRekrutteringSpinal svulst | BensvulstKina
-
Peking University Third HospitalHar ikke rekruttert ennåRuptur av fremre korsbåndKina
-
Royal Brompton & Harefield NHS Foundation TrustUniversity of Oxford; National Institute for Health Research, United KingdomFullførtSøvnapné, obstruktiv | Posisjonell søvnapnéStorbritannia
-
Thomas Jefferson UniversityRekrutteringProstata karsinomForente stater
-
Oregon Research InstituteFullført
-
Sarah BlaylockVA Office of Research and DevelopmentFullførtFalle | LavsynForente stater
-
Tel Aviv UniversityFullført