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CompletedNCT04965415SSWellUpdated Jul 16, 2021

Small+Safe+Well: A Longitudinal Study of TWH in Small Business

An interventional study of Health Links + Leadership Training and Health Links in Life Style, sponsored by Colorado School of Public Health. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-16.

Sponsored by Colorado School of Public Health · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 years 11 months after the study started (first participant enrolled Apr 2017, registered Mar 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
2,175
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Workers in small businesses bear a disproportionate burden of occupational fatalities, illnesses, and injuries. The investigators conducted an intervention research project to determine how an intervention at the organizational level modifies business Total Worker Health (TWH) practices, safety climate, and health climate. In turn, the investigators aimed to determine whether organizational TWH adoption impacts individual workers' lifestyle health outcomes. In addition, the investigators also evaluated the use of the RE-AIM public health impact evaluation framework in the small business setting, with the intention of improving generalizability, maintenance, and dissemination of interventions and of guiding future TWH intervention design for both research and practice. The investigators conducted a lagged randomized controlled trial (L-RCT) to determine how different doses of an organizational-level TWH intervention (Health Links vs. Health Links + TWH Leadership Training) resulted in improvement and maintenance of TWH programming and organizational climates for safety and health, in small enterprises, over 36 months. The investigators also evaluated whether it resulted in improvements in workforce lifestyle health risks. In the short and mid-term, the goals and outputs of this project is a greater understanding of the theoretical underpinnings of TWH interventions and a model to test the implementation of the TWH interventions as well as an improvement the ability of TWH researchers and practitioners to apply this knowledge to TWH intervention design, implementation and evaluation to ensure generalizability. The long-term goal of this project is to impact worker safety, health and well-being through the continued use of these principles in small businesses.

02

Conditions studied

  • Life Style
03

In context

Lead sponsor

Colorado School of Public Health is the lead sponsor of 8 studies on the registry; none 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

  • Colorado small business with less than 500 employees

Exclusion criteria

Exclusion Criteria:

  • Business does not operate in Colorado or has more than 500 employees
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
2,175 participants (actual)

Study arms

  • Active comparator
    Lagged

    Businesses in the lagged arm participated in Health Links for one year from their baseline assessment to their first follow-up assessment one year later. They were eligible to participate in the Leadership Training after both assessments were completed.

    Behavioral: Health Links

  • Experimental
    Early

    Businesses in this arm participated in Health Links + Leadership Training for one year from their baseline assessment to their first follow-up assessment one year later.

    Behavioral: Health Links + Leadership Training

Interventions

  • BehavioralHealth Links + Leadership Training

    Help businesses undergo transactional (i.e., business management practices) and transformational (i.e., business leadership and culture) change. Transactional change component: Health Links is an existing community-based intervention that seeks to help businesses - especially small and medium-sized businesses - incorporate Total Worker Health (TWH) programming into their business practices through assessment, advising, and certification. There is evidence that this consultation intervention is effective at helping businesses develop and implement policies and programs.Transformational change component: The experimental arm includes TWH leadership training for small business owners and other senior leaders. This is a three-month training that includes assessments, in-person training, and virtual training transfer activities. The goal is to help the leader understand their organization's current approach to TWH, identify areas for improvement, and to take action.

  • BehavioralHealth Links

    Health Links is an existing community-based intervention that seeks to help businesses - especially small and medium-sized businesses - create a culture of both safety and health. Health Links does this by helping businesses incorporate Total Worker Health (TWH) programming into their business practices through assessment, advising, and certification. There is evidence that this consultation intervention is effective at helping businesses develop and implement policies and programs.

06

What researchers measure

Primary outcomes

  1. Business Total Worker Health Policies and Programs

    Total score, out of 100, on an assessment that measures the quantity of policies and programs that the business develops and implements to protect and promote their employees' health and safety.

    Time frame: up to four years

  2. Health Climate

    Health climate (1-5 Likert scale, Strongly disagree to strongly agree) measures employee perceptions of whether their organization is committed to their health and well-being. Zweber, Z. M., Henning, R. A., \& Magley, V. J. (2016). A practical scale for Multi-Faceted Organizational Health Climate Assessment. Journal of Occupational Health Psychology, 21(2), 250-259.

    Time frame: up to four years

  3. Safety Climate

    Safety climate (1-5 Likert scale, Strongly disagree to strongly agree) measures employee perceptions of whether their organization is committed to their safety. Lee, J., Huang, Y.-H., Robertson, M. M., Murphy, L. A., Garabet, A., \& Chang, W.-R. (2014). External validity of a generic safety climate scale for lone workers across different industries and companies. Accident Analysis \& Prevention, 63, 138-145.

    Time frame: up to four years

  4. Overall health

    A self-reported measure of overall health asks the respondent to rate their overall health (1-5 Likert scale, Poor to excellent). Schwatka, NV, Atherly, A, Dally, MJ, Fang, H, vS Brockbank, C, Tenney, L, Goetzel, RZ, Jinnett, K, Witter, R, Reynolds, S, McMillen, J, Newman, L. (2017). Health risk factors as predictors of workers' compensation claim occurrence and cost. Occupational and Environmental Medicine. 74(1): 14-23.

    Time frame: up to four years

  5. Well-being

    A self-reported measure of well-being asks the respondent to rate their well-being related to mood (1-5 Likert scale, Poor to excellent). Staehr Johansen, K. (1998). The use of well-being measures in primary health care - the DepCare project. In World Health Organization, Regional Office for Europe: Well-Being Measures in Primary Health Care - The DepCare Project. Geneva, World Healthcare Organization.

    Time frame: up to four years

  6. Stress

    A self-reported measure of stress asks the respondent to rate their level of stress related to work, home, and finances (1-5 Likert scale, Never to always). Schwatka, NV, Atherly, A, Dally, MJ, Fang, H, vS Brockbank, C, Tenney, L, Goetzel, RZ, Jinnett, K, Witter, R, Reynolds, S, McMillen, J, Newman, L. (2017). Health risk factors as predictors of workers' compensation claim occurrence and cost. Occupational and Environmental Medicine. 74(1): 14-23.

    Time frame: up to four years

  7. Sleep

    A self-reported measure of sleep asks the respondent about the number of hours of sleep they get in a day (\<6 hours, 6-6.9 hours, 7-8 hours, and \>8 hours). Schwatka, NV, Atherly, A, Dally, MJ, Fang, H, vS Brockbank, C, Tenney, L, Goetzel, RZ, Jinnett, K, Witter, R, Reynolds, S, McMillen, J, Newman, L. (2017). Health risk factors as predictors of workers' compensation claim occurrence and cost. Occupational and Environmental Medicine. 74(1): 14-23.

    Time frame: up to four years

  8. Exercise

    A self-reported measure of exercise asks the respondent about the number of days they get moderate to vigorous physical activity for at least 30 minutes. Schwatka, NV, Atherly, A, Dally, MJ, Fang, H, vS Brockbank, C, Tenney, L, Goetzel, RZ, Jinnett, K, Witter, R, Reynolds, S, McMillen, J, Newman, L. (2017). Health risk factors as predictors of workers' compensation claim occurrence and cost. Occupational and Environmental Medicine. 74(1): 14-23.

    Time frame: up to four years

07

Study locations

1 site
  • University of Colorado Anschutz Medical Campus
    Aurora, Colorado 80045, United States
08

References and documents

Publications

  • Schwatka NV, Tenney L, Dally MJ, Scott J, Brown CE, Weitzenkamp D, Shore E, Newman LS. Small business Total Worker Health: A conceptual and methodological approach to facilitating organizational change. Occup Health Sci. 2018 Mar;2(1):25-41. doi: 10.1007/s41542-018-0013-9. PubMed 30740514 ↗

Related links

Individual participant data

Plan to share: Yes — All business assessments and employee survey data collected by the researchers will be made available in a timely manner upon written request.

Supporting information: Study protocol

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04965415
Lead sponsor
Colorado School of Public Health
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)
Responsible party
Lee Newman (Distinguished professor, Colorado School of Public Health) — Principal investigator
First posted
Jul 16, 2021
Start date
Apr 1, 2017
Primary completion
May 1, 2020
Completion
May 1, 2020
Last update
Jul 16, 2021

Study contacts

Lee Newman, MA MA
principal investigator · Colorado School of Public Health

Oversight

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

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