Clinical trial NCT04965415: Small+Safe+Well: A Longitudinal Study of TWH in Small Business
Official title: Small+Safe+Well: A Longitudinal Study of TWH in Small Business
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Life Style
Lead sponsor: Colorado School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute for Occupational Safety and Health (NIOSH/CDC)
First posted: 2021-07-16
Enrollment: 2175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Businesses are randomly assigned to one of two arms, and the intervention is evaluated using a stepped wedge design. In the active comparator arm, businesses participate in an existing organizational-level intervention called Health Links in the first year of the study. Businesses randomly assigned to the experimental arm in the first year receive the TWH leadership program, in addition to Health Links. Businesses in the active comparator arm eventually receive the experimental intervention in the second year of the study.
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Colorado small business with less than 500 employees

Exclusion Criteria:

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

Primary outcomes:
measure: Business Total Worker Health Policies and Programs
timeFrame: up to four years
measure: Health Climate
timeFrame: up to four years
measure: Safety Climate
timeFrame: up to four years
measure: Overall health
timeFrame: up to four years
measure: Well-being
timeFrame: up to four years
measure: Stress
timeFrame: up to four years
measure: Sleep
timeFrame: up to four years
measure: Exercise
timeFrame: up to four years
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: Colorado School of Public Health
name: Lee Newman, MA MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.