Success & Health Impacts For Transit Drivers During Onboarding

Obesity Clinical Trial

— SHIFTOnboard  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03730792
• Other study ID #: 3061
• Secondary ID: 2R01HL105495-06A
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: July 31, 2023

Study information

• Verified date: February 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 284
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• SHIFT Onboard Intervention
A 12-month onboarding process and social challenge supported with goal setting, computer-based training, self-monitoring, and group motivational interviewing.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Olson R, Wipfli B, Thompson SV, Elliot DL, Anger WK, Bodner T, Hammer LB, Perrin NA. Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States. Am J Public Health. 2016 Sep;106(9):1698-706. doi: 10.2105/AJPH.2016.303262. Epub 2016 Jul 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Baseline body weight as a moderator of intervention effects on weight at follow-ups	Baseline body weight evaluated as a moderator of intervention effects at 12 and 24 months.	Baseline, 12, and 24 months
Other	Change from baseline in blood pressure at 12 and 24 months	Direct measurement in mmHg.	Baseline, 12, and 24 months
Other	Change from baseline in triglycerides	Direct measurement of triglycerides via Cholestech LDX Analyzer in mg/dL.	Baseline, 12, and 24 months
Other	Change from baseline in Hemoglobin A1c at 12 and 24 months	HbA1c measured via fingerprick blood sample.	Baseline, 12, and 24 months
Other	Change from baseline in Total cholesterol	Total cholesterol measured from fingerstick blood sample via Cholestech LDX Analyzer in mg/dL.	Baseline, 12, and 24 months
Other	Change from baseline in HDL cholesterol	HDL measured from fingerstick blood sample via Cholestech LDX Analyzer in mg/dL.	Baseline, 12 and 24 months
Other	Change from baseline in LDL cholesterol	LDL measured from fingerstick blood sample via Cholestech LDX Analyzer in mg/dL.	Baseline, 12 and 24 months
Other	Change from baseline in the LDL/HDL cholesterol ratio	LDL/HDL cholesterol ratio computed from values measured via Cholestech LDX Analyzer in mg/dL	Baseline, 12, and 24 months
Primary	Change from baseline in body weight at 12 and 24 months	Directly measured body weight in kg.	Baseline, 12, and 24 months
Primary	Body Mass Index	Calculated from directly measured weight and height (kg/m^2).	Baseline, 12 and 24 months
Primary	Change from baseline in percent body fat	Percent body fat measured through bioelectric impedence	Baseline, 12 and 24 months
Primary	Change from baseline in self-reported fruit and vegetable intake at 12 and 24 months	Survey measures of fruit and vegetable intake.	Baseline, 12, and 24 months
Primary	Change from baseline in self-reported consumption of high fat foods at 12 and 24 months.	Survey measure of high fat food consumption frequency and portion sizes.	Baseline, 12 and 24 months.
Primary	Change from baseline in self-reported sugary food and drink consumption at 12 and 24 months	Survey measure of the frequency of sugary food and drink consumption.	Baseline, 12 and 24 months.
Primary	Change from baseline in self-reported fast food consumption.	Survey measure of the frequency of fast food consumption.	Baseline, 12 and 24 months.
Primary	Change from baseline in self-reported physical activity at 12 and 24 months	Survey measures of daily/weekly physical activity levels.	Baseline, 12, and 24 months
Primary	Change from baseline in actigraphically measured physical activity at 12 and 24 months	Actigraphy measures of daily/weekly of physical activity levels.	Baseline, 12 and 24 months
Primary	Change from baseline in self-reported sleep quality at 12 and 24 months	Survey measures of typical sleep quality.	Baseline, 12, and 24 months
Primary	Change from baseline in self-reported sleep quantity at 12 and 24 months	Survey measures of typical daily sleep time.	Baseline, 12 and 24 months
Primary	Change from baseline in actigraphically measured sleep quality at 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
Primary	Change from baseline in actigraphically measured sleep quantity at 12 and 24 months	Actigraphy measures of sleep duration in minutes for the daily main sleep period and naps.	Baseline, 12 and 24 months
Secondary	Changes in job role conflict	Survey measures of job role conflict.	Baseline, 12, and 24 months
Secondary	Changes in perceived acceptance by others	Survey measures of perceived acceptance by others.	Baseline, 12 and 24 months
Secondary	Changes in job-related self-efficacy	Survey measures of job-related self-efficacy.	Baseline, 12 and 24 months
Secondary	Changes in job satisfaction	Survey measure of job satisfaction	Baseline, 12 and 24 months
Secondary	Changes in intention to remain at job	Survey measures of intention to remain.	Baseline, 12 and 24 months
Secondary	Economic cost-benefit factors	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)
Secondary	Absenteeism	Organizational records of absenteeism for new bus operators	Baseline, 12 and 24 months
Secondary	Job turnover	Organizational records of job turnover among new bus operators	Baseline, 12 and 24 months
Secondary	Bus collisions	Organizational records of bus collisions among new bus operators	Baseline, 12 and 24 months
Secondary	Injuries	Organizational records of bus operator and passenger injuries	Baseline, 12 and 24 months