Clinical trial NCT03730792: Success & Health Impacts For Transit Drivers During Onboarding
Official title: SHIFT Onboard: Protecting New Transit Operators Against Safety and Health Hazards
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Body Weight
Nutrition
Physical Activity
Sleep
Stress
Occupational Health
Working Conditions
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-11-05
Enrollment: 284
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in body weight at 12 and 24 months
timeFrame: Baseline, 12, and 24 months
measure: Body Mass Index
timeFrame: Baseline, 12 and 24 months
measure: Change from baseline in percent body fat
timeFrame: Baseline, 12 and 24 months
measure: Change from baseline in self-reported fruit and vegetable intake at 12 and 24 months
timeFrame: Baseline, 12, and 24 months
measure: Change from baseline in self-reported consumption of high fat foods at 12 and 24 months.
timeFrame: Baseline, 12 and 24 months.
measure: Change from baseline in self-reported sugary food and drink consumption at 12 and 24 months
timeFrame: Baseline, 12 and 24 months.
measure: Change from baseline in self-reported fast food consumption.
timeFrame: Baseline, 12 and 24 months.
measure: Change from baseline in self-reported physical activity at 12 and 24 months
timeFrame: Baseline, 12, and 24 months
measure: Change from baseline in actigraphically measured physical activity at 12 and 24 months
timeFrame: Baseline, 12 and 24 months
measure: Change from baseline in self-reported sleep quality at 12 and 24 months
timeFrame: Baseline, 12, and 24 months
measure: Change from baseline in self-reported sleep quantity at 12 and 24 months
timeFrame: Baseline, 12 and 24 months
measure: Change from baseline in actigraphically measured sleep quality at 12 and 24 months
timeFrame: Baseline, 12 and 24 months
measure: Change from baseline in actigraphically measured sleep quantity at 12 and 24 months
timeFrame: Baseline, 12 and 24 months
Secondary outcomes:
measure: Changes in job role conflict
timeFrame: Baseline, 12, and 24 months
measure: Changes in perceived acceptance by others
timeFrame: Baseline, 12 and 24 months
measure: Changes in job-related self-efficacy
timeFrame: Baseline, 12 and 24 months
measure: Changes in job satisfaction
timeFrame: Baseline, 12 and 24 months
measure: Changes in intention to remain at job
timeFrame: Baseline, 12 and 24 months
measure: Economic cost-benefit factors
timeFrame: 12 month intervention costs, and a target minimum of four years of corporate data for each agency (2 historical, 2 during study period)
measure: Absenteeism
timeFrame: Baseline, 12 and 24 months
measure: Job turnover
timeFrame: Baseline, 12 and 24 months
measure: Bus collisions
timeFrame: Baseline, 12 and 24 months
measure: Injuries
timeFrame: Baseline, 12 and 24 months
Other outcomes:
measure: Baseline body weight as a moderator of intervention effects on weight at follow-ups
timeFrame: Baseline, 12, and 24 months
measure: Change from baseline in blood pressure at 12 and 24 months
timeFrame: Baseline, 12, and 24 months
measure: Change from baseline in triglycerides
timeFrame: Baseline, 12, and 24 months
measure: Change from baseline in Hemoglobin A1c at 12 and 24 months
timeFrame: Baseline, 12, and 24 months
measure: Change from baseline in Total cholesterol
timeFrame: Baseline, 12, and 24 months
measure: Change from baseline in HDL cholesterol
timeFrame: Baseline, 12 and 24 months
measure: Change from baseline in LDL cholesterol
timeFrame: Baseline, 12 and 24 months
measure: Change from baseline in the LDL/HDL cholesterol ratio
timeFrame: Baseline, 12, and 24 months
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Ryan Olson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.