Life StyleSSWellNCT04965415
Small+Safe+Well: A Longitudinal Study of TWH in Small Business
A study testing Health Links + Leadership Training and Health Links in people with Life Style, run by Colorado School of Public Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Life Style
- What is being tested?
- Health Links + Leadership Training and Health Links
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,175 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 1 May 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
- Colorado small business with less than 500 employees
Who cannot join
- Business does not operate in Colorado or has more than 500 employees
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
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.
- Conditions
- Life Style
- Being tested
- Health Links + Leadership Training, Health Links
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Links + Leadership TrainingBehavioural
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 LinksBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Lagged | Active comparator | 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. Receives: Behavioral: Health Links |
| Early | Experimental | 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. Receives: Behavioral: Health Links + Leadership Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to four years
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.
Measured: up to four years
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.
Measured: up to four years
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.
Measured: up to four years
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.
Measured: up to four years
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.
Measured: up to four years
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.
Measured: up to four years
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.
Measured: up to four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start1 Apr 2017
- Primary completion1 May 2020
- Study completion1 May 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 Life StyleStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 2,175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Principal investigator, Lee Newman, Colorado School of Public Health
- Investigators
- Lee Newman, MA MA, Principal investigator, Colorado School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965415
- Sponsor's protocol ID
- U19OH011227
- Acronym
- SSWell
- Status last verified
- Jul 2021
- First submitted
- 19 Mar 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All business assessments and employee survey data collected by the researchers will be made available in a timely manner upon written request.
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small+Safe+Well: A Longitudinal Study of TWH in Small Business
- ClinicalTrials.gov ID
- NCT04965415
- Acronym / sponsor ID
- SSWell / U19OH011227
- Conditions
- Life Style
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,175 participants (actual)
- Lead sponsor
- Colorado School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 16 Jul 2021 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lagged | Active comparator | Behavioral: Health LinksBusinesses 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. |
| Early | Experimental | Behavioral: Health Links + Leadership TrainingBusinesses 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Colorado small business with less than 500 employees
Key exclusion criteria (1 listed)
- Business does not operate in Colorado or has more than 500 employees
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 |
|---|---|---|
| Health Links + Leadership TrainingHelp 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. | Behavioural | Early |
| Health LinksHealth 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. | Behavioural | Lagged |
Primary outcome
Business Total Worker Health Policies and Programs
Time frame: up to four years
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.
Health Climate
Time frame: up to four years
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.
Safety Climate
Time frame: up to four years
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.
Overall health
Time frame: up to four years
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.
Well-being
Time frame: up to four years
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.
Stress
Time frame: up to four years
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.
Sleep
Time frame: up to four years
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.
Exercise
Time frame: up to four years
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.
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 16 Jul 2021.
- Background: PubMed 30740514Schwatka 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.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All business assessments and employee survey data collected by the researchers will be made available in a timely manner upon written request.
Related trials for Life Style
Not yet recruiting
Personalized Dietary Feedback to Reduce Hepatic Steatosis in Patients With MASLD
MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), MetALD
RecruitingPhase 4
AI-Assisted Lifestyle Intervention Versus Tirzepatide for Obesity and Newly Diagnosed Type 2 Diabetes
Obesity, Diabetes Mellitus, Type 2
Not yet recruitingObservational study
AI-Based Model for Predicting Type 2 Diabetes Risk Using Lifestyle Factors Among Senior Nursing Students
Type 2 Diabetes Mellitus
Recruiting
Synchronous vs Asynchronous Remotely Delivered Lifestyle Interventions
Obesity
Recruiting
Lifestyle Medicine for Type 2 Diabetes Remission in Pakistan
Type-2 Diabetes Mellitus (T2DM), Diabetes Remission
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.
Lee Newman, MA MA principal investigator
Colorado School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Links + Leadership Training and Health Links in people with Life Style, run by Colorado School of Public Health 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 16 Jul 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?
Business Total Worker Health Policies and Programs (time frame: up to four years). The study lists 8 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 NCT04965415, 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 16 Jul 2021.