<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03781245</url>
  </required_header>
  <id_info>
    <org_study_id>IRB13-1948</org_study_id>
    <nct_id>NCT03781245</nct_id>
  </id_info>
  <brief_title>Integrated Approaches to Health and Safety in a Dynamic Construction Work Environment</brief_title>
  <acronym>ARM For SUBS</acronym>
  <official_title>Integrated Approaches to Health and Safety in a Dynamic Construction Work Environment (All the Right Moves for Subcontractors)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harvard School of Public Health (HSPH)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Harvard School of Public Health (HSPH)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      &quot;All the Right Moves for Subcontractors&quot; aims to improve safety, health and well-being,&#xD;
      through the development of a communication infrastructure with supplemental tools where&#xD;
      construction workers and company mangers (project, operations and safety) work together to&#xD;
      collaboratively identify problems and strategies to improve their conditions of work. The&#xD;
      intervention is grounded in the key characteristics of integrated organizational&#xD;
      interventions to improve workers' health safety and well-being detailed in Harvard Center for&#xD;
      Work, Health and Well-being's Implementation Guidelines (McLellan et al, 2016).&#xD;
&#xD;
      The intervention involves a cyclical approach through which the research team facilitate a&#xD;
      participatory process to identify workers' health concerns, prioritize these concerns, use an&#xD;
      action planning process to identify and operationalize solutions, and develop a&#xD;
      company-specific evaluation plan to measure change. We will evaluate this program by&#xD;
      measuring safety climate, health climate, pain and injury and health behaviors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 24, 2018</start_date>
  <completion_date type="Actual">November 20, 2020</completion_date>
  <primary_completion_date type="Actual">September 28, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Worker Outcomes: Injury assessed by the Nordic Musculoskeletal Questionnaire</measure>
    <time_frame>Change from Baseline at 2 months, 4 months, and 6 months</time_frame>
    <description>NMQ has been applied to a wide range of occupational groups to evaluate musculoskeletal problems Scale:0-1 0:minimum&#xD;
1:maximum</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Worker Outcomes: Pain assessed by the Nordic Musculoskeletal Questionnaire</measure>
    <time_frame>Change from Baseline at 2 months, 4 months, and 6 months</time_frame>
    <description>NMQ has been applied to a wide range of occupational groups to evaluate musculoskeletal problems Scale:0-1 0:minimum&#xD;
1:maximum</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Enterprise Outcomes: Work Productivity and Activity Impairment assessed by Work Productivity and Activity Impairment Questionnaire (WPAI)</measure>
    <time_frame>Change from Baseline at 2 months, 4 months, and 6 months</time_frame>
    <description>Work Productivity and Activity Impairment Questionnaire (WPAI) measures impairment due to the specified problem and all health problems.&#xD;
Scale:0-1 0:minimum&#xD;
1:maximum</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Enterprise Outcomes: Health Climate assessed by questions modified from safety climate scale for construction workers</measure>
    <time_frame>Change from Baseline at 2 months, 4 months, and 6 months</time_frame>
    <description>Questions adapted from safety climate scale: Jorgensen, E., Sokas, R. K., Nickels, L., Gao, W., &amp; Gittleman, J. L. (2007). An English/Spanish safety climate scale for construction workers. American journal of industrial medicine, 50(6), 438-442.&#xD;
Scale:0-1 0:minimum&#xD;
1:maximum</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Enterprise Outcomes: Safety Climate assessed by using the validated scale: An English/Spanish safety climate scale for construction workers.</measure>
    <time_frame>Change from Baseline at 2 months, 4 months, and 6 months</time_frame>
    <description>Jorgensen, E., Sokas, R. K., Nickels, L., Gao, W., &amp; Gittleman, J. L. (2007). An English/Spanish safety climate scale for construction workers. American journal of industrial medicine, 50(6), 438-442.&#xD;
Scale:0-1 0:minimum&#xD;
1:maximum</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Worker Health Behaviors: Diet</measure>
    <time_frame>Change from Baseline at 2 months, 4 months, and 6 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worker Health Behaviors: Leisure Physical Activity</measure>
    <time_frame>Change from Baseline at 2 months, 4 months, and 6 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worker Health Behaviors: Alcohol Use assessed by using validated questions from NIAAA</measure>
    <time_frame>Change from Baseline at 2 months, 4 months, and 6 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worker Health Behaviors: Tobacco Use assessed by modifying questions from the National Adult Tobacco Survey (NATS)</measure>
    <time_frame>Change from Baseline at 2 months, 4 months, and 6 months</time_frame>
    <description>Dichotomous questions adapted from the National Adult Tobacco Survey (NATS) Scale:0-2 0:minimum 2:maximum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Work Environment: Co-worker Support assessed by assessed by Job Content Questionnaire (JCQ), a validated scale.</measure>
    <time_frame>Change from Baseline at 2 months, 4 months, and 6 months</time_frame>
    <description>Uses questions from the Job Content Questionnaire (JCQ), a validated scale by Karasek_et_al__1998 Scale:0-1 0:minimum&#xD;
1:maximum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Work Environment: Supervisor Support assessed by Job Content Questionnaire (JCQ), a validated scale.</measure>
    <time_frame>Change from Baseline at 2 months, 4 months, and 6 months</time_frame>
    <description>Uses questions from the Job Content Questionnaire (JCQ), a validated scale by Karasek_et_al__1998 Scale:0-1 0:minimum&#xD;
1:maximum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Work Environment: Communication assessed by Job Content Questionnaire (JCQ), a validated scale.</measure>
    <time_frame>Change from Baseline at 2 months, 4 months, and 6 months</time_frame>
    <description>Uses questions from the Job Content Questionnaire (JCQ), a validated scale by Karasek_et_al__1998 Scale:0-1 0:minimum&#xD;
1:maximum</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">144</enrollment>
  <condition>Worker Health</condition>
  <condition>Work Injury</condition>
  <condition>Safety Climate</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Early</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention is administered for cycle 1 and 2 with researchers and following this the company continues intervention independently.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lagged</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention is not administered for cycle 1; researchers administer intervention in cycle 2 and following this the company continues intervention independently.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>All the Right Moves for Subcontractors</intervention_name>
    <description>&quot;All the Right Moves for Subcontractors&quot; 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).&#xD;
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.</description>
    <arm_group_label>Early</arm_group_label>
    <arm_group_label>Lagged</arm_group_label>
    <other_name>ARM for SUBS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All workers employed by the recruited contractors at the eligible worksites&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Companies with less than 5 workers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Harvard T.H. Chan School of Public Health</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://centerforworkhealth.sph.harvard.edu/sites/default/files/10.12.17_Guidelines_Screen_post.pdf</url>
    <description>Implementing an Integrated Approach Weaving Worker Health, Safety, and Well-being into the Fabric of Your Organization.</description>
  </link>
  <reference>
    <citation>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 &quot;ARM for Subs&quot; Trial. Int J Environ Res Public Health. 2020 Jul 15;17(14):5093. doi: 10.3390/ijerph17145093.</citation>
    <PMID>32679687</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>November 3, 2021</last_update_submitted>
  <last_update_submitted_qc>November 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harvard School of Public Health (HSPH)</investigator_affiliation>
    <investigator_full_name>Jack Dennerlein</investigator_full_name>
    <investigator_title>Associate Director, Center for Work, Health, &amp; Well-being</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03781245
org study id: IRB13-1948
nct id: NCT03781245
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
"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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Worker Outcomes: Injury assessed by the Nordic Musculoskeletal Questionnaire
time frame: Change from Baseline at 2 months, 4 months, and 6 months
description: NMQ has been applied to a wide range of occupational groups to evaluate musculoskeletal problems Scale:0-1 0:minimum
1:maximum
measure: Worker Outcomes: Pain assessed by the Nordic Musculoskeletal Questionnaire
time frame: Change from Baseline at 2 months, 4 months, and 6 months
description: NMQ has been applied to a wide range of occupational groups to evaluate musculoskeletal problems Scale:0-1 0:minimum
1:maximum
measure: 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
description: 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
measure: 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
description: 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
measure: 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
description: 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
measure: Worker Health Behaviors: Diet
time frame: Change from Baseline at 2 months, 4 months, and 6 months
description: 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
measure: Worker Health Behaviors: Leisure Physical Activity
time frame: Change from Baseline at 2 months, 4 months, and 6 months
description: 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
measure: 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
description: 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
measure: 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
description: Dichotomous questions adapted from the National Adult Tobacco Survey (NATS) Scale:0-2 0:minimum 2:maximum
measure: 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
description: Uses questions from the Job Content Questionnaire (JCQ), a validated scale by Karasek_et_al__1998 Scale:0-1 0:minimum
1:maximum
measure: 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
description: Uses questions from the Job Content Questionnaire (JCQ), a validated scale by Karasek_et_al__1998 Scale:0-1 0:minimum
1:maximum
measure: 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
description: Uses questions from the Job Content Questionnaire (JCQ), a validated scale by Karasek_et_al__1998 Scale:0-1 0:minimum
1:maximum
arm group label: Early
arm group type: Experimental
description: Intervention is administered for cycle 1 and 2 with researchers and following this the company continues intervention independently.
arm group label: Lagged
arm group type: Active Comparator
description: Intervention is not administered for cycle 1; researchers administer intervention in cycle 2 and following this the company continues intervention independently.
intervention type: Other
intervention name: All the Right Moves for Subcontractors
description: "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.
arm group label: Early
arm group label: Lagged
other name: ARM for SUBS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
url: http://centerforworkhealth.sph.harvard.edu/sites/default/files/10.12.17_Guidelines_Screen_post.pdf
description: Implementing an Integrated Approach Weaving Worker Health, Safety, and Well-being into the Fabric of Your Organization.
citation: 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.
PMID: 32679687
responsible party type: Principal Investigator
investigator affiliation: Harvard School of Public Health (HSPH)
investigator full name: Jack Dennerlein
investigator title: Associate Director, Center for Work, Health, & Well-being
sharing ipd: No