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Corrections Work's Adverse Effects and a Total Worker Health Program to Enhance Well-being

Primary Purpose

Occupational Stress, Health Behavior, Safety Issues

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total Worker Health Mindfulness Enhanced Program
Sponsored by
Kerry Kuehl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Occupational Stress focused on measuring Health Promotion, Mindfulness, Occupational Health, Total Worker Health, Safety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: - Currently employed as a corrections professional at participating Oregon Department of Corrections facilities (Coffee Creek Correctional Facility and Oregon State Correctional Institution) for at least one month Exclusion Criteria: - Those who are not employed with participating Oregon Department of Corrections facilities listed above.

Sites / Locations

  • Oregon State Correctional InstituteRecruiting
  • Coffee Creek Correctional FacilityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness Enhanced Web App-enabled Total Worker Health Program

Arm Description

The Total Worker Health Mindful Program will include 12, 45-minute sessions completed each week at participant's workplace. Sessions will be guided by written curriculum and focus on healthy eating, exercise, sleep and stress reducing behaviors enhanced by mindfulness activities. Participants will be provided with free enrollment codes to use the Headspace® application (app).

Outcomes

Primary Outcome Measures

Change in Perceived stress
Perceived Stress Scale Short Form (PSS-4)
Change in Mood
The Positive and Negative Affect Schedule (PANAS); Profile of Mood States Short Form (POMS-SF)
Change in Eating Habits
Relevant excerpts from the National Cancer Institute's fruit and vegetable all day screener and Diet History Questionnaire (DHQ), percent calories from fat, and health dietary behaviors (Elliot et al., 2007; Kuehl et al., 2014)
Change in Physical Activity
Change in physical activity will be assessed using this survey question: "How many days per week did you exercise or take part in moderate physical activities that increased your breathing a bit for a total of at least 30 minutes during the day (such as brisk walking or bicycling)?". This is measured in days per week (with a scale of 0-7 days). Relevant excerpts from previous research on physical activity behaviors (Elliot et al., 2007).
Change in Sleep
Change in sleep will be assessed using this survey question: "In the past seven days, I had trouble sleeping" measures in a scale of 1-5 (1=very good, 2=good, 3=fair, 4=poor, 5=very poor). Short Form from the National Institutes of Health's Patient-Reported Outcomes Information System's Sleep Disturbance (PROMIS-SD-SF); Pittsburgh Sleep Quality Index (PSQI)
Change in Work-life balance
Change in work-life balance will be assessed using this survey question: "In the past month, how often have you felt that you were able to control the important things in your life?" measured in a scale of 1-5 (1=none of the time, 2=a little of the time, 3=some of the time, 4=most of the time, 5=all of the time). Ballin et al., 2021.
Change in Feelings about organization
Change in feelings about organization will be assessed using this survey question: "The Department of Corrections has processes in place that improve my work environment" measured with a scale from 1-5 (1=strongly disagree, 2=disagree, 3=neither disagree or agree, 4=agree, 5=strongly agree). Ballin et al., 2021.

Secondary Outcome Measures

Change in Life Satisfaction
Change in life satisfaction will be assessed with the survey question: "Would you say your general health is:" with a scale of a)excellent, b)very good, c)good, d)fair, and e)poor.
Change in Body Mass Index
Change in Body mass index will measured in kg/m2.
Change in Blood Pressure
Changes in blood pressure will be measured in mmHg.
Change in Vascular Reactivity
Changes in Vascular reactivity will be measured in adjusted temperature rebound (aTR) between 0-2.
Change in C-reactive Protein
Changes in C-reactive protein will be measured in mg/L.
Change in Cytokine Interleukin IL-6
Changes in cytokine Interleukin IL-6 will be measured in pg/mL.
Change in Tumour Necrosis Factor alpha
Changes in Tumour Necrosis Factor alpha will be measured in pg/mL.
Change in telomere length
Changes in telomere length will be measured in kb.
Change in Worker's Compensation Claims
Change in Worker's Compensation Claims from Oregon Department of Corrections Human Resources data that report the number of worker's compensation claims there are.
Change in Days Injured
Change in Worker's Compensation Claims from Oregon Department of Corrections Human Resources data that report the number of missed days due to work-related illness or injury

Full Information

First Posted
October 25, 2022
Last Updated
February 10, 2023
Sponsor
Kerry Kuehl
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1. Study Identification

Unique Protocol Identification Number
NCT05608889
Brief Title
Corrections Work's Adverse Effects and a Total Worker Health Program to Enhance Well-being
Official Title
Corrections Work's Adverse Effects and a Total Worker Health Program to Enhance Well-being
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kerry Kuehl

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Conduct a quasi-experimental pre-post study of a mindfulness-enhanced, web/app-enabled, scalable Total Worker Health (TWH) program among higher stress Corrections Professionals. The primary outcomes relate to behaviors promoted by the program: being mindful/reduced stress/improved mood; healthier eating; more physical activity; greater restorative sleep; improved work-life balance and greater positive feelings about the organization.
Detailed Description
This proposed project will assess an innovative, scalable total worker health and wellness intervention among high stress Corrections Professionals. As stated in the proposal request, organizational and interpersonal factors have been associated with significant stress among Corrections Professionals, but there is limited assessment of effective and feasible interventions to mitigate these stress factors. Our current research has established robust constructs for characteristics of the organization and work environment, noting significant relationships with perceived stress. This critical understanding along with corresponding adverse mental and physical effects informs our proposed intervention to reduce potential stressors, enhance wellbeing, improve work performance, and reduce health care costs. This project will include a prospective interrupted time-series effectiveness trial of a mindfulness-enhanced, website/application-based, scalable Total Worker Health (TWH) program among higher risk corrections personnel working in restrictive housing units. Quantitative outcomes will include process measures; validated self-report indices of primary and secondary outcomes, and proximal potentially mediating factors; anthropometrics; laboratory studies of inflammation, vascular reactivity, and cellular aging; measures of job performance and health care costs. Qualitative measures will provide a deeper understanding of the quantitative findings. At program conclusion, there will be a cost effective easy to use work based health and wellness program tailored to corrections departments ready for dissemination. The robust dissemination plan includes coordinating the website and digital materials with the American Correctional Association marketing and media campaign site along with presentations at national corrections conferences making this freely available to all law enforcement and corrections personnel and agencies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occupational Stress, Health Behavior, Safety Issues, Mental Health Wellness 1
Keywords
Health Promotion, Mindfulness, Occupational Health, Total Worker Health, Safety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study will use a quasi-experimental pre-post design to compare values of outcome measures at the three times points: baseline, immediately post-intervention (3 months after baseline), and follow-up (9 months after baseline). Randomization of the intervention is not feasible at the individual level due to contamination effects within a site and no appropriate control condition. Furthermore, as each of the sites is unique, a randomized cluster design would not be able to account for confounders since there are only three sites, each with institutional differences. An advantage of the pre-post design is that each participant will act as their own control, increasing the power of the study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Enhanced Web App-enabled Total Worker Health Program
Arm Type
Experimental
Arm Description
The Total Worker Health Mindful Program will include 12, 45-minute sessions completed each week at participant's workplace. Sessions will be guided by written curriculum and focus on healthy eating, exercise, sleep and stress reducing behaviors enhanced by mindfulness activities. Participants will be provided with free enrollment codes to use the Headspace® application (app).
Intervention Type
Behavioral
Intervention Name(s)
Total Worker Health Mindfulness Enhanced Program
Intervention Description
The intervention will be delivered during 12, 45-minute weekly meetings of Correctional Professionals while on shift. Those sessions will be a combination of a video, mindfulness activity, and a group learning activity. It will conclude with members stating personal goals that will be followed up at the next meeting. Sessions will be scripted to make them easy to implement with high fidelity, and include tasks, learning activities, and wrap-up with practice instructions for each week. Coworkers will be responsible for running the sessions, which promotes shared norms and social support.
Primary Outcome Measure Information:
Title
Change in Perceived stress
Description
Perceived Stress Scale Short Form (PSS-4)
Time Frame
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Title
Change in Mood
Description
The Positive and Negative Affect Schedule (PANAS); Profile of Mood States Short Form (POMS-SF)
Time Frame
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Title
Change in Eating Habits
Description
Relevant excerpts from the National Cancer Institute's fruit and vegetable all day screener and Diet History Questionnaire (DHQ), percent calories from fat, and health dietary behaviors (Elliot et al., 2007; Kuehl et al., 2014)
Time Frame
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Title
Change in Physical Activity
Description
Change in physical activity will be assessed using this survey question: "How many days per week did you exercise or take part in moderate physical activities that increased your breathing a bit for a total of at least 30 minutes during the day (such as brisk walking or bicycling)?". This is measured in days per week (with a scale of 0-7 days). Relevant excerpts from previous research on physical activity behaviors (Elliot et al., 2007).
Time Frame
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Title
Change in Sleep
Description
Change in sleep will be assessed using this survey question: "In the past seven days, I had trouble sleeping" measures in a scale of 1-5 (1=very good, 2=good, 3=fair, 4=poor, 5=very poor). Short Form from the National Institutes of Health's Patient-Reported Outcomes Information System's Sleep Disturbance (PROMIS-SD-SF); Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Title
Change in Work-life balance
Description
Change in work-life balance will be assessed using this survey question: "In the past month, how often have you felt that you were able to control the important things in your life?" measured in a scale of 1-5 (1=none of the time, 2=a little of the time, 3=some of the time, 4=most of the time, 5=all of the time). Ballin et al., 2021.
Time Frame
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Title
Change in Feelings about organization
Description
Change in feelings about organization will be assessed using this survey question: "The Department of Corrections has processes in place that improve my work environment" measured with a scale from 1-5 (1=strongly disagree, 2=disagree, 3=neither disagree or agree, 4=agree, 5=strongly agree). Ballin et al., 2021.
Time Frame
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Secondary Outcome Measure Information:
Title
Change in Life Satisfaction
Description
Change in life satisfaction will be assessed with the survey question: "Would you say your general health is:" with a scale of a)excellent, b)very good, c)good, d)fair, and e)poor.
Time Frame
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Title
Change in Body Mass Index
Description
Change in Body mass index will measured in kg/m2.
Time Frame
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Title
Change in Blood Pressure
Description
Changes in blood pressure will be measured in mmHg.
Time Frame
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Title
Change in Vascular Reactivity
Description
Changes in Vascular reactivity will be measured in adjusted temperature rebound (aTR) between 0-2.
Time Frame
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Title
Change in C-reactive Protein
Description
Changes in C-reactive protein will be measured in mg/L.
Time Frame
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Title
Change in Cytokine Interleukin IL-6
Description
Changes in cytokine Interleukin IL-6 will be measured in pg/mL.
Time Frame
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Title
Change in Tumour Necrosis Factor alpha
Description
Changes in Tumour Necrosis Factor alpha will be measured in pg/mL.
Time Frame
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Title
Change in telomere length
Description
Changes in telomere length will be measured in kb.
Time Frame
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Title
Change in Worker's Compensation Claims
Description
Change in Worker's Compensation Claims from Oregon Department of Corrections Human Resources data that report the number of worker's compensation claims there are.
Time Frame
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Title
Change in Days Injured
Description
Change in Worker's Compensation Claims from Oregon Department of Corrections Human Resources data that report the number of missed days due to work-related illness or injury
Time Frame
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Currently employed as a corrections professional at participating Oregon Department of Corrections facilities (Coffee Creek Correctional Facility and Oregon State Correctional Institution) for at least one month Exclusion Criteria: - Those who are not employed with participating Oregon Department of Corrections facilities listed above.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kerry S. Kuehl, MD, Dr.PH
Phone
503-494-5991
Email
kuehlk@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Carol Defrancesco, MALS, RDN, LD
Phone
503-310-5036
Email
defrance@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry S. Kuehl, MD, DrPH
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon State Correctional Institute
City
Salem
State/Province
Oregon
ZIP/Postal Code
97310
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Kuehl
Phone
503-494-5991
Email
kuehlk@ohsu.edu
Facility Name
Coffee Creek Correctional Facility
City
Wilsonville
State/Province
Oregon
ZIP/Postal Code
97070
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Kuehl
Phone
503-494-5991
Email
kuehlk@ohsu.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17293760
Citation
Elliot DL, Goldberg L, Kuehl KS, Moe EL, Breger RK, Pickering MA. The PHLAME (Promoting Healthy Lifestyles: Alternative Models' Effects) firefighter study: outcomes of two models of behavior change. J Occup Environ Med. 2007 Feb;49(2):204-13. doi: 10.1097/JOM.0b013e3180329a8d.
Results Reference
background
PubMed Identifier
24847475
Citation
Kuehl KS, Elliot DL, Goldberg L, MacKinnon DP, Vila BJ, Smith J, Miocevic M, O'Rourke HP, Valente MJ, DeFrancesco C, Sleigh A, McGinnis W. The safety and health improvement: enhancing law enforcement departments study: feasibility and findings. Front Public Health. 2014 May 8;2:38. doi: 10.3389/fpubh.2014.00038. eCollection 2014.
Results Reference
background
PubMed Identifier
26542616
Citation
Cherniack M, Dussetschleger J, Dugan A, Farr D, Namazi S, El Ghaziri M, Henning R. Participatory action research in corrections: The HITEC 2 program. Appl Ergon. 2016 Mar;53 Pt A:169-80. doi: 10.1016/j.apergo.2015.09.011. Epub 2015 Nov 2.
Results Reference
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PubMed Identifier
27687118
Citation
Creswell JD. Mindfulness Interventions. Annu Rev Psychol. 2017 Jan 3;68:491-516. doi: 10.1146/annurev-psych-042716-051139. Epub 2016 Sep 28.
Results Reference
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PubMed Identifier
24073114
Citation
Elliot DL, Mackinnon DP, Mabry L, Kisbu-Sakarya Y, Defrancesco CA, Coxe SJ, Kuehl KS, Moe EL, Goldberg L, Favorite KC. Worksite wellness program implementation: a model of translational effectiveness. Transl Behav Med. 2012 Jun;2(2):228-35. doi: 10.1007/s13142-012-0121-z.
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Citation
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MacKinnon DP, Elliot DL, Thoemmes F, Kuehl KS, Moe EL, Goldberg L, Burrell GL, Ranby KW. Long-term effects of a worksite health promotion program for firefighters. Am J Health Behav. 2010 Nov-Dec;34(6):695-706. doi: 10.5993/ajhb.34.6.6.
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Links:
URL
https://www.scirp.org/journal/paperinformation.aspx?paperid=109823
Description
Ballin, J. , Niederhausen, M. , Kuehl, K. , Elliot, D. , McGinnis, W. and DeFrancesco, C. (2021) Defining Stress among Corrections Professionals. Open Journal of Preventive Medicine, 11, 237-250. doi: 10.4236/ojpm.2021.116019.

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Corrections Work's Adverse Effects and a Total Worker Health Program to Enhance Well-being

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