CClinicalTrials.gg
CompletedNCT04913168Updated Apr 6, 2023

Organizational Approaches to TWH for Low-Income Workers

An interventional study of Front Line Worker Pilot Project in Work-related Injury, sponsored by Harvard School of Public Health (HSPH). Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-06.

Sponsored by Harvard School of Public Health (HSPH) · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 years 9 months after the study started (first participant enrolled Aug 2017, registered May 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
197
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Work-related Injury

Keywords

  • worker health
  • occupational safety and health
03

In context

Lead sponsor

Harvard School of Public Health (HSPH) is the lead sponsor of 150 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • All front line workers including chefs, cooks, food preparers, servers, dishwashers, and cashiers

Exclusion criteria

Exclusion Criteria:

  • Front Line workers with supervisory responsibilities
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
197 participants (actual)

Study arms

  • Experimental
    Control Group

    Control Group; no intervention

    Other: Front Line Worker Pilot Project

  • Experimental
    Intervention Group

    Intervention Group; receives 13 month intervention

    Other: Front Line Worker Pilot Project

Interventions

  • OtherFront Line Worker Pilot Project

    13-month intervention targeting workplace policies and programs focused on changes to safety and ergonomics, job enrichment, and work intensity for front line food service workers practices,

06

What researchers measure

Primary outcomes

  1. Change in Reduction in Pain and Injuries Worker Survey

    Nordic Scale

    Time frame: 13 months

  2. Change in Improvements in Front Line Worker Turnover Intention Worker Survey

    Turnover Intention Scale

    Time frame: 13 months

  3. Change in Improvement in Front Line Worker Well Being Worker Survey

    WHO Wellbeing Scale

    Time frame: 13 months

07

Study locations

1 site
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
08

References and documents

Publications

  • Sorensen G, Peters SE, Nielsen K, Stelson E, Wallace LM, Burke L, Nagler EM, Roodbari H, Karapanos M, Wagner GR. Implementation of an organizational intervention to improve low-wage food service workers' safety, health and wellbeing: findings from the Workplace Organizational Health Study. BMC Public Health. 2021 Oct 16;21(1):1869. doi: 10.1186/s12889-021-11937-9. PubMed 34656090 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04913168
Lead sponsor
Harvard School of Public Health (HSPH)
Responsible party
Glorian Sorensen (Professor of Social and Behavioral Sciences, Harvard School of Public Health (HSPH)) — Principal investigator
First posted
Jun 4, 2021
Start date
Aug 1, 2017
Primary completion
Mar 13, 2020
Completion
Mar 13, 2020
Last update
Apr 6, 2023

Study contacts

Glorian Sorensen, PhD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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