- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05608889
Corrections Work's Adverse Effects and a Total Worker Health Program to Enhance Well-being
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Salem, Oregon, United States, 97310
- Recruiting
- Oregon State Correctional Institute
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Wilsonville, Oregon, United States, 97070
- Recruiting
- Coffee Creek Correctional Facility
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mindfulness Enhanced Web App-enabled Total Worker Health Program
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).
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Perceived stress
Time Frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Perceived Stress Scale Short Form (PSS-4)
|
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Change in Mood
Time Frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
The Positive and Negative Affect Schedule (PANAS); Profile of Mood States Short Form (POMS-SF)
|
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Change in Eating Habits
Time Frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
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 between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Change in Physical Activity
Time Frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
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 between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Change in Sleep
Time Frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
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 between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Change in Work-life balance
Time Frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
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 between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Change in Feelings about organization
Time Frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
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.
|
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Life Satisfaction
Time Frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
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 between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Change in Body Mass Index
Time Frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Change in Body mass index will measured in kg/m2.
|
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Change in Blood Pressure
Time Frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Changes in blood pressure will be measured in mmHg.
|
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Change in Vascular Reactivity
Time Frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Changes in Vascular reactivity will be measured in adjusted temperature rebound (aTR) between 0-2.
|
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Change in C-reactive Protein
Time Frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Changes in C-reactive protein will be measured in mg/L.
|
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Change in Cytokine Interleukin IL-6
Time Frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Changes in cytokine Interleukin IL-6 will be measured in pg/mL.
|
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Change in Tumour Necrosis Factor alpha
Time Frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Changes in Tumour Necrosis Factor alpha will be measured in pg/mL.
|
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Change in telomere length
Time Frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Changes in telomere length will be measured in kb.
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Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Change in Worker's Compensation Claims
Time Frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
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.
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Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Change in Days Injured
Time Frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
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
|
Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Creswell JD. Mindfulness Interventions. Annu Rev Psychol. 2017 Jan 3;68:491-516. doi: 10.1146/annurev-psych-042716-051139. Epub 2016 Sep 28.
- von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg. 2014 Dec;12(12):1495-9. doi: 10.1016/j.ijsu.2014.07.013. Epub 2014 Jul 18.
- 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.
- 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.
- 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.
- 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.
- Hammer LB, Ernst Kossek E, Bodner T, Crain T. Measurement development and validation of the Family Supportive Supervisor Behavior Short-Form (FSSB-SF). J Occup Health Psychol. 2013 Jul;18(3):285-96. doi: 10.1037/a0032612. Epub 2013 Jun 3.
- Hammer LB, Truxillo DM, Bodner T, Rineer J, Pytlovany AC, Richman A. Effects of a Workplace Intervention Targeting Psychosocial Risk Factors on Safety and Health Outcomes. Biomed Res Int. 2015;2015:836967. doi: 10.1155/2015/836967. Epub 2015 Oct 18.
- 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.
- Olson R, Wipfli B, Thompson SV, Elliot DL, Anger WK, Bodner T, Hammer LB, Perrin NA. Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States. Am J Public Health. 2016 Sep;106(9):1698-706. doi: 10.2105/AJPH.2016.303262. Epub 2016 Jul 27.
- Rohlman DS, Parish M, Elliot DL, Hanson G, Perrin N. Addressing Younger Workers' Needs: The Promoting U through Safety and Health (PUSH) Trial Outcomes. Healthcare (Basel). 2016 Aug 10;4(3):55. doi: 10.3390/healthcare4030055.
- Tang YY, Yang L, Leve LD, Harold GT. Improving Executive Function and its Neurobiological Mechanisms through a Mindfulness-Based Intervention: Advances within the Field of Developmental Neuroscience. Child Dev Perspect. 2012 Dec;6(4):361-366. doi: 10.1111/j.1750-8606.2012.00250.x.
- Uegaki K, de Bruijne MC, van der Beek AJ, van Mechelen W, van Tulder MW. Economic evaluations of occupational health interventions from a company's perspective: a systematic review of methods to estimate the cost of health-related productivity loss. J Occup Rehabil. 2011 Mar;21(1):90-9. doi: 10.1007/s10926-010-9258-0.
- Zweber ZM, Henning RA, Magley VJ. A practical scale for Multi-Faceted Organizational Health Climate Assessment. J Occup Health Psychol. 2016 Apr;21(2):250-9. doi: 10.1037/a0039895. Epub 2015 Nov 16.
Helpful Links
- 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.
- Elliot D, Kuehl K, Goldberg L. Taking an evidence-based Total Worker HealthTM program online. 1st International Symposium on Total Worker Health; Bethesda, Maryland; 2014.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-R2-CX-0006 (OTHER_GRANT: U.S. Department of Justice (DOJ))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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