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

Life Style Clinical Trial

— SSWell  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04965415
• Other study ID #: U19OH011227
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: July 2021
• Source: Colorado School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2175
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Colorado small business with less than 500 employees

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Life Style

Intervention

Behavioral:
• Health 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.
• Health 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.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Colorado School of Public Health	National Institute for Occupational Safety and Health (NIOSH/CDC)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to four years
Primary	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.	up to four years
Primary	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.	up to four years
Primary	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.	up to four years
Primary	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.	up to four years
Primary	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.	up to four years
Primary	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.	up to four years
Primary	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.	up to four years

External Links

•   Study website