Work-related InjuryNCT04913168
Organizational Approaches to TWH for Low-Income Workers
A study testing Front Line Worker Pilot Project in people with Work-related Injury, run by Harvard School of Public Health (HSPH) at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Work-related Injury
- What is being tested?
- Front Line Worker Pilot Project
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All front line workers including chefs, cooks, food preparers, servers, dishwashers, and cashiers
Who cannot join
- Front Line workers with supervisory responsibilities
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
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:
- 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.
- 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.
- Conditions
- Work-related Injury
- Being tested
- Front Line Worker Pilot Project
- Keywords
- worker health, occupational safety and health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Front Line Worker Pilot ProjectOther
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,
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Control Group; no intervention Receives: Other: Front Line Worker Pilot Project |
| Intervention Group | Experimental | Intervention Group; receives 13 month intervention Receives: Other: Front Line Worker Pilot Project |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Reduction in Pain and Injuries Worker Survey
Nordic Scale
Measured: 13 months
Change in Improvements in Front Line Worker Turnover Intention Worker Survey
Turnover Intention Scale
Measured: 13 months
Change in Improvement in Front Line Worker Well Being Worker Survey
WHO Wellbeing Scale
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start1 Aug 2017
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Work-related InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glorian Sorensen, Harvard School of Public Health (HSPH)
- Investigators
- Glorian Sorensen, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913168
- Sponsor's protocol ID
- TWH for Low Income Workers
- Status last verified
- Apr 2023
- First submitted
- 25 May 2021
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organizational Approaches to TWH for Low-Income Workers
- ClinicalTrials.gov ID
- NCT04913168
- Acronym / sponsor ID
- TWH for Low Income Workers
- Conditions
- Work-related Injury
- Keywords
- worker health, occupational safety and health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: Front Line Worker Pilot ProjectControl Group; no intervention |
| Intervention Group | Experimental | Other: Front Line Worker Pilot ProjectIntervention Group; receives 13 month intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All front line workers including chefs, cooks, food preparers, servers, dishwashers, and cashiers
Key exclusion criteria (1 listed)
- Front Line workers with supervisory responsibilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Front Line Worker Pilot Project13-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, | Other | Control Group, Intervention Group |
Primary outcome
Change in Reduction in Pain and Injuries Worker Survey
Time frame: 13 months
Nordic Scale
Change in Improvements in Front Line Worker Turnover Intention Worker Survey
Time frame: 13 months
Turnover Intention Scale
Change in Improvement in Front Line Worker Well Being Worker Survey
Time frame: 13 months
WHO Wellbeing Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Derived from this study: PubMed 34656090Sorensen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glorian Sorensen, PhD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Front Line Worker Pilot Project in people with Work-related Injury, run by Harvard School of Public Health (HSPH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Reduction in Pain and Injuries Worker Survey (time frame: 13 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04913168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.