Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04913168 |
| Other study ID # |
TWH for Low Income Workers |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2017 |
| Est. completion date |
March 13, 2020 |
Study information
| Verified date |
April 2023 |
| Source |
Harvard School of Public Health (HSPH) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
There is an urgent need for evidence-based interventions to reduce risk of musculoskeletal
disorders (MSDs) and improve health and safety behaviors for low-income workers. Upstream
interventions addressing these organizational characteristics and work experiences may be
especially effective in preventing adverse health outcomes because they address underlying
sources of elevated risk particularly important for low-wage workers. Low-wage workers have
less schedule control, more irregular working hours, and shortened breaks due to time
pressure to complete work tasks. The objective is to develop and test feasible intervention
methods to modify the work organization and contribute to reductions in MSD risk, and
improvements work-related well-being and job satisfaction. First, this study will identify
characteristics of the work organization that can be feasibly modified through changes in
management practices, based on interviews with food service managers and focus groups with
workers. Second, the investigators will determine the feasibility and potential efficacy of
an integrated TWH intervention in improving workers' ergonomic practices, MSD symptom, as
well as in changing the work organization and environment related to work-related well-being
and job satisfaction.
The contribution of this study will be significant because it is expected to contribute to
reducing disparities in these health outcomes by directly intervening on an underlying source
of these disparities.
Description:
The food service industry employs 9.5 million workers in the U.S, many of whom are at
elevated risk for a range of poor health outcomes. NIOSH's Total Worker Health™ (TWH) Program
provides an innovative approach for addressing the shared pathways in the work organization
and environment that impact both MSD risk and health and safety behaviors. This study takes
advantage of an unusual opportunity to demonstrate the impact of changes in the work
organization in collaboration with an industry partner that has committed to making such
changes in concert with this study. Our central hypothesis is that an intervention targeting
the work organization, as well as the work environment will show promising improvements in
MSD outcomes and improvements in work-related well-being and job satisfaction.
The Specific Aims of this study include:
1. Identify factors in the work organization, expected to be associated with MSD risk and
work-related well-being and job satisfaction, which can be feasibly modified through
changes in management practices. The investigators will conduct formative research using
qualitative data from workers and managers to explore two overarching issues to inform
intervention development specific to this setting: (a) What work organizational factors
do workers perceive as priorities for their safety and health? (b) What factors in the
work organization do worksite and district managers believe can be feasibly modified
through changes in policies and practices? The investigators will additionally explore
barriers and facilitators to these changes, and factors contributing to sustainability.
2. Determine the feasibility and potential efficacy of an integrated TWH intervention
designed to improve the work organization and environment, workers' MSD symptoms,
ergonomic practices, and work-related well-being and job satisfaction. To provide the
next level of evidence and prepare for a full-scale randomized control trial (RCT), the
investigators will conduct a proof-of-concept (PoC) trial to evaluate an integrated TWH
intervention in ten food service worksites randomly assigned to intervention and control
conditions, to: (a) assess the feasibility of intervention delivery and the
acceptability of the intervention; and (b) provide preliminary estimates of baseline
levels, change from baseline to final, and intra-class correlation. The investigators
will explore the working hypothesis that between pre- and post-intervention, compared to
workers in control worksites, workers in intervention sites will report greater
improvements in the primary outcomes, including ergonomic practices and MSD symptoms,
work-related well-being and job satisfaction; and secondary outcomes, including
improvements in the work organization and environment.
This PoC intervention will be tested in10 food service worksites randomly assigned to
intervention and control. The 13-month intervention will target changes in the organizational
and physical work environment and management practices, and supporting safe ergonomic
practices and factors related to work-related wellbeing and job satisfaction. The
investigators will compare differences between intervention and control sites in changes
between pre- and post-intervention in worker health and safety behaviors and MSD symptoms
through surveys of workers, and in the work organization and environment through manager
surveys and on-site walk-through's. A rigorous process evaluation will be used to assess
intervention feasibility. The contribution of this study will be significant because it is
expected to contribute to reducing disparities in these health outcomes by directly
intervening on an underlying source of these disparities.
