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

1 febbraio 2023 aggiornato da: 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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Anticipato)

284

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Oregon
      • Portland, Oregon, Stati Uniti, 97239
        • Oregon Health & Science University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

21 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Nessun intervento: Usual Practice Control
Participants experience standard or "Usual Practices" in new employee onboarding processes at their workplace.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline in body weight at 12 and 24 months
Lasso di tempo: Baseline, 12, and 24 months
Directly measured body weight in kg.
Baseline, 12, and 24 months
Body Mass Index
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in job role conflict
Lasso di tempo: Baseline, 12, and 24 months
Survey measures of job role conflict.
Baseline, 12, and 24 months
Changes in perceived acceptance by others
Lasso di tempo: Baseline, 12 and 24 months
Survey measures of perceived acceptance by others.
Baseline, 12 and 24 months
Changes in job-related self-efficacy
Lasso di tempo: Baseline, 12 and 24 months
Survey measures of job-related self-efficacy.
Baseline, 12 and 24 months
Changes in job satisfaction
Lasso di tempo: Baseline, 12 and 24 months
Survey measure of job satisfaction
Baseline, 12 and 24 months
Changes in intention to remain at job
Lasso di tempo: Baseline, 12 and 24 months
Survey measures of intention to remain.
Baseline, 12 and 24 months
Economic cost-benefit factors
Lasso di tempo: 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
Lasso di tempo: Baseline, 12 and 24 months
Organizational records of absenteeism for new bus operators
Baseline, 12 and 24 months
Job turnover
Lasso di tempo: Baseline, 12 and 24 months
Organizational records of job turnover among new bus operators
Baseline, 12 and 24 months
Bus collisions
Lasso di tempo: Baseline, 12 and 24 months
Organizational records of bus collisions among new bus operators
Baseline, 12 and 24 months
Injuries
Lasso di tempo: Baseline, 12 and 24 months
Organizational records of bus operator and passenger injuries
Baseline, 12 and 24 months

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Baseline body weight as a moderator of intervention effects on weight at follow-ups
Lasso di tempo: 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
Lasso di tempo: Baseline, 12, and 24 months
Direct measurement in mmHg.
Baseline, 12, and 24 months
Change from baseline in triglycerides
Lasso di tempo: 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
Lasso di tempo: Baseline, 12, and 24 months
HbA1c measured via fingerprick blood sample.
Baseline, 12, and 24 months
Change from baseline in Total cholesterol
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Ryan Olson, PhD, Oregon Health and Science University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 luglio 2019

Completamento primario (Anticipato)

31 luglio 2023

Completamento dello studio (Anticipato)

31 luglio 2023

Date di iscrizione allo studio

Primo inviato

30 ottobre 2018

Primo inviato che soddisfa i criteri di controllo qualità

1 novembre 2018

Primo Inserito (Effettivo)

5 novembre 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 febbraio 2023

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 febbraio 2023

Ultimo verificato

1 febbraio 2023

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 3061
  • 2R01HL105495-06A1 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su SHIFT Onboard Intervention

3
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