Worker HealthARM For SUBSNCT03781245

Integrated Approaches to Health and Safety in a Dynamic Construction Work Environment

A study testing All the Right Moves for Subcontractors in people with Worker Health and Work Injury, run by Harvard School of Public Health (HSPH) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Worker Health, Work Injury, Safety Climate
What is being tested?: All the Right Moves for Subcontractors
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 144 participants
Where: 1 siteUnited States
Study dates: 24 Jul 2018to 20 Nov 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 workers employed by the recruited contractors at the eligible worksites

Who cannot join

Companies with less than 5 workers

Trial locations and contacts

1 site in 1 country.

United States1 site

Harvard T.H. Chan School of Public Health
Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Integrated Approaches to Health and Safety in a Dynamic Construction Work Environment (All the Right Moves for Subcontractors)

"All the Right Moves for Subcontractors" aims to improve safety, health and well-being, through the development of a communication infrastructure with supplemental tools where construction workers and company mangers (project, operations and safety) work together to collaboratively identify problems and strategies to improve their conditions of work. The intervention is grounded in the key characteristics of integrated organizational interventions to improve workers' health safety and well-being detailed in Harvard Center for Work, Health and Well-being's Implementation Guidelines (McLellan et al, 2016).

The intervention involves a cyclical approach through which the research team facilitate a participatory process to identify workers' health concerns, prioritize these concerns, use an action planning process to identify and operationalize solutions, and develop a company-specific evaluation plan to measure change. We will evaluate this program by measuring safety climate, health climate, pain and injury and health behaviors.

Conditions: Worker Health, Work Injury, Safety Climate, Pain
Being tested: All the Right Moves for Subcontractors
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

All the Right Moves for SubcontractorsOther
Also called ARM for SUBS
"All the Right Moves for Subcontractors" aims to improve safety, health and wellbeing, through the development of a communication infrastructure with supplemental tools where construction workers and company mangers work together to collaboratively identify problems and strategies to improve their conditions of work. The intervention is grounded in the key characteristics of integrated organizational interventions to improve workers' health safety and wellbeing detailed in Harvard Center for Work, Health and Wellbeing's Implementation Guidelines (McLellan et al, 2016).
The intervention involves a cyclical approach through which the research team facilitate a participatory process to identify workers' health concerns, prioritize these concerns, use an action planning process to identify and operationalize solutions, and develop a company-specific evaluation plan to measure change.

Study groups in NCT03781245
Study group	Role	What they receive
Early	Experimental	Intervention is administered for cycle 1 and 2 with researchers and following this the company continues intervention independently. Receives: Other: All the Right Moves for Subcontractors
Lagged	Active comparator	Intervention is not administered for cycle 1; researchers administer intervention in cycle 2 and following this the company continues intervention independently. Receives: Other: All the Right Moves for Subcontractors

What is being measured

The primary outcome is the main question the study is designed to answer.

Worker Outcomes: Injury assessed by the Nordic Musculoskeletal Questionnaire
NMQ has been applied to a wide range of occupational groups to evaluate musculoskeletal problems Scale:0-1 0:minimum
1:maximum
Measured: Change from Baseline at 2 months, 4 months, and 6 months
Worker Outcomes: Pain assessed by the Nordic Musculoskeletal Questionnaire
NMQ has been applied to a wide range of occupational groups to evaluate musculoskeletal problems Scale:0-1 0:minimum
1:maximum
Measured: Change from Baseline at 2 months, 4 months, and 6 months
Enterprise Outcomes: Work Productivity and Activity Impairment assessed by Work Productivity and Activity Impairment Questionnaire (WPAI)
Work Productivity and Activity Impairment Questionnaire (WPAI) measures impairment due to the specified problem and all health problems.
Scale:0-1 0:minimum
1:maximum
Measured: Change from Baseline at 2 months, 4 months, and 6 months
Enterprise Outcomes: Health Climate assessed by questions modified from safety climate scale for construction workers
Questions adapted from safety climate scale: Jorgensen, E., Sokas, R. K., Nickels, L., Gao, W., \& Gittleman, J. L. (2007). An English/Spanish safety climate scale for construction workers. American journal of industrial medicine, 50(6), 438-442.
Scale:0-1 0:minimum
1:maximum
Measured: Change from Baseline at 2 months, 4 months, and 6 months
Enterprise Outcomes: Safety Climate assessed by using the validated scale: An English/Spanish safety climate scale for construction workers.
Jorgensen, E., Sokas, R. K., Nickels, L., Gao, W., \& Gittleman, J. L. (2007). An English/Spanish safety climate scale for construction workers. American journal of industrial medicine, 50(6), 438-442.
Scale:0-1 0:minimum
1:maximum
Measured: Change from Baseline at 2 months, 4 months, and 6 months

Secondary outcomes (7)

Worker Health Behaviors: Diet
PrimeScreen Questionnaire; Rifas-Shiman SL, Willett WC, Lobb R, Kotch J, Dart C, Gillman MW. PrimeScreen, a brief dietary screening tool: reproducibility and comparability with both a longer food frequency questionnaire and biomarkers. Public Health Nutr. 2001 Apr;4(2):249-54 Scale: 0-4 0:minimum 4:maximum
Measured: Change from Baseline at 2 months, 4 months, and 6 months
Worker Health Behaviors: Leisure Physical Activity
International Physical Activity Questionnaire (Short Form)http://uacc.arizona.edu/sites/default/files/ipaq_english_telephone_short.pdf Scale: 0-7 days 0=minimum 7=maximum
Measured: Change from Baseline at 2 months, 4 months, and 6 months
Worker Health Behaviors: Alcohol Use assessed by using validated questions from NIAAA
National Institute on Alcohol Abuse and Alcoholism Scale:0-9 0:minimum 9:maximum https://www.niaaa.nih.gov/research/guidelines-and-resources/recommended-alcohol-questions
Measured: Change from Baseline at 2 months, 4 months, and 6 months
Worker Health Behaviors: Tobacco Use assessed by modifying questions from the National Adult Tobacco Survey (NATS)
Dichotomous questions adapted from the National Adult Tobacco Survey (NATS) Scale:0-2 0:minimum 2:maximum
Measured: Change from Baseline at 2 months, 4 months, and 6 months
Psychosocial Work Environment: Co-worker Support assessed by assessed by Job Content Questionnaire (JCQ), a validated scale.
Uses questions from the Job Content Questionnaire (JCQ), a validated scale by Karasek_et_al__1998 Scale:0-1 0:minimum
1:maximum
Measured: Change from Baseline at 2 months, 4 months, and 6 months
Psychosocial Work Environment: Supervisor Support assessed by Job Content Questionnaire (JCQ), a validated scale.
Uses questions from the Job Content Questionnaire (JCQ), a validated scale by Karasek_et_al__1998 Scale:0-1 0:minimum
1:maximum
Measured: Change from Baseline at 2 months, 4 months, and 6 months
Psychosocial Work Environment: Communication assessed by Job Content Questionnaire (JCQ), a validated scale.
Uses questions from the Job Content Questionnaire (JCQ), a validated scale by Karasek_et_al__1998 Scale:0-1 0:minimum
1:maximum
Measured: Change from Baseline at 2 months, 4 months, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jul 201820 Nov 2020

First posted19 Dec 2018
Study start24 Jul 2018
Primary completion28 Sep 2020
Study completion20 Nov 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 Worker HealthStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03781245
Sponsor's protocol ID: IRB13-1948
Acronym: ARM For SUBS
Status last verified: Nov 2021
First submitted: 20 Nov 2018
Last updated: 10 Nov 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Peters SE, Trieu HD, Manjourides J, Katz JN, Dennerlein JT. Designing a Participatory Total Worker Health(R) Organizational Intervention for Commercial Construction Subcontractors to Improve Worker Safety, Health, and Well-Being: The "ARM for Subs" Trial. Int J Environ Res Public Health. 2020 Jul 15;17(14):5093. doi: 10.3390/ijerph17145093.
PubMed 32679687

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Worker Health trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Integrated Approaches to Health and Safety in a Dynamic Construction Work Environment (All the Right Moves for Subcontractors)
ClinicalTrials.gov ID: NCT03781245
Acronym / sponsor ID: ARM For SUBS / IRB13-1948
Conditions: Worker Health, Work Injury, Safety Climate, Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 144 participants (actual)
Lead sponsor: Harvard School of Public Health (HSPH)University, hospital or other
Study start: 24 Jul 2018 (actual)
Primary completion: 28 Sep 2020 (actual)
Study completion: 20 Nov 2020 (actual)
First posted: 19 Dec 2018 (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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Early	Experimental	Other: All the Right Moves for SubcontractorsIntervention is administered for cycle 1 and 2 with researchers and following this the company continues intervention independently.
Lagged	Active comparator	Other: All the Right Moves for SubcontractorsIntervention is not administered for cycle 1; researchers administer intervention in cycle 2 and following this the company continues intervention independently.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

All workers employed by the recruited contractors at the eligible worksites

Key exclusion criteria (1 listed)

Companies with less than 5 workers

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
All the Right Moves for SubcontractorsAlso: ARM for SUBS"All the Right Moves for Subcontractors" aims to improve safety, health and wellbeing, through the development of a communication infrastructure with supplemental tools where construction workers and company mangers work together to collaboratively identify problems and strategies to improve their conditions of work. The intervention is grounded in the key characteristics of integrated organizational interventions to improve workers' health safety and wellbeing detailed in Harvard Center for Work, Health and Wellbeing's Implementation Guidelines (McLellan et al, 2016). The intervention involves a cyclical approach through which the research team facilitate a participatory process to identify workers' health concerns, prioritize these concerns, use an action planning process to identify and operationalize solutions, and develop a company-specific evaluation plan to measure change.	Other	Early, Lagged

Primary outcome

Worker Outcomes: Injury assessed by the Nordic Musculoskeletal Questionnaire
Time frame: Change from Baseline at 2 months, 4 months, and 6 months
NMQ has been applied to a wide range of occupational groups to evaluate musculoskeletal problems Scale:0-1 0:minimum 1:maximum
Worker Outcomes: Pain assessed by the Nordic Musculoskeletal Questionnaire
Time frame: Change from Baseline at 2 months, 4 months, and 6 months
NMQ has been applied to a wide range of occupational groups to evaluate musculoskeletal problems Scale:0-1 0:minimum 1:maximum
Enterprise Outcomes: Work Productivity and Activity Impairment assessed by Work Productivity and Activity Impairment Questionnaire (WPAI)
Time frame: Change from Baseline at 2 months, 4 months, and 6 months
Work Productivity and Activity Impairment Questionnaire (WPAI) measures impairment due to the specified problem and all health problems. Scale:0-1 0:minimum 1:maximum
Enterprise Outcomes: Health Climate assessed by questions modified from safety climate scale for construction workers
Time frame: Change from Baseline at 2 months, 4 months, and 6 months
Questions adapted from safety climate scale: Jorgensen, E., Sokas, R. K., Nickels, L., Gao, W., \& Gittleman, J. L. (2007). An English/Spanish safety climate scale for construction workers. American journal of industrial medicine, 50(6), 438-442. Scale:0-1 0:minimum 1:maximum
Enterprise Outcomes: Safety Climate assessed by using the validated scale: An English/Spanish safety climate scale for construction workers.
Time frame: Change from Baseline at 2 months, 4 months, and 6 months
Jorgensen, E., Sokas, R. K., Nickels, L., Gao, W., \& Gittleman, J. L. (2007). An English/Spanish safety climate scale for construction workers. American journal of industrial medicine, 50(6), 438-442. Scale:0-1 0:minimum 1:maximum

7 secondary outcomes

Worker Health Behaviors: Diet
Time frame: Change from Baseline at 2 months, 4 months, and 6 months
Worker Health Behaviors: Leisure Physical Activity
Time frame: Change from Baseline at 2 months, 4 months, and 6 months
Worker Health Behaviors: Alcohol Use assessed by using validated questions from NIAAA
Time frame: Change from Baseline at 2 months, 4 months, and 6 months
Worker Health Behaviors: Tobacco Use assessed by modifying questions from the National Adult Tobacco Survey (NATS)
Time frame: Change from Baseline at 2 months, 4 months, and 6 months
Psychosocial Work Environment: Co-worker Support assessed by assessed by Job Content Questionnaire (JCQ), a validated scale.
Time frame: Change from Baseline at 2 months, 4 months, and 6 months
Psychosocial Work Environment: Supervisor Support assessed by Job Content Questionnaire (JCQ), a validated scale.
Time frame: Change from Baseline at 2 months, 4 months, and 6 months
Psychosocial Work Environment: Communication assessed by Job Content Questionnaire (JCQ), a validated scale.
Time frame: Change from Baseline at 2 months, 4 months, and 6 months

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 10 Nov 2021.
Background: PubMed 32679687Peters SE, Trieu HD, Manjourides J, Katz JN, Dennerlein JT. Designing a Participatory Total Worker Health(R) Organizational Intervention for Commercial Construction Subcontractors to Improve Worker Safety, Health, and Well-Being: The "ARM for Subs" Trial. Int J Environ Res Public Health. 2020 Jul 15;17(14):5093. doi: 10.3390/ijerph17145093.
Implementing an Integrated Approach Weaving Worker Health, Safety, and Well-being into the Fabric of Your Organization.Link provided by the sponsor.
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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing All the Right Moves for Subcontractors in people with Worker Health and Work 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 10 Nov 2021. 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?

Worker Outcomes: Injury assessed by the Nordic Musculoskeletal Questionnaire (time frame: Change from Baseline at 2 months, 4 months, and 6 months). The study lists 5 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 NCT03781245, 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 10 Nov 2021.