NCT05608889

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

November 9, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

October 25, 2022

Last Update Submit

February 10, 2023

Conditions

Keywords

Health PromotionMindfulnessOccupational HealthTotal Worker HealthSafety

Outcome Measures

Primary Outcomes (7)

  • Change in Perceived stress

    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

    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

    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

    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

    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

    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

    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 Outcomes (10)

  • Change in Life Satisfaction

    Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion

  • Change in Body Mass Index

    Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion

  • Change in Blood Pressure

    Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion

  • Change in Vascular Reactivity

    Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion

  • Change in C-reactive Protein

    Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion

  • +5 more secondary outcomes

Study Arms (1)

Mindfulness Enhanced Web App-enabled Total Worker Health Program

EXPERIMENTAL

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).

Behavioral: Total Worker Health Mindfulness Enhanced Program

Interventions

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.

Mindfulness Enhanced Web App-enabled Total Worker Health Program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • \- Those who are not employed with participating Oregon Department of Corrections facilities listed above.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oregon State Correctional Institute

Salem, Oregon, 97310, United States

RECRUITING

Coffee Creek Correctional Facility

Wilsonville, Oregon, 97070, United States

RECRUITING

Related Publications (15)

  • 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.

    PMID: 17293760BACKGROUND
  • 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.

    PMID: 24847475BACKGROUND
  • 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(Pt A):169-80. doi: 10.1016/j.apergo.2015.09.011. Epub 2015 Nov 2.

    PMID: 26542616BACKGROUND
  • Creswell JD. Mindfulness Interventions. Annu Rev Psychol. 2017 Jan 3;68:491-516. doi: 10.1146/annurev-psych-042716-051139. Epub 2016 Sep 28.

    PMID: 27687118BACKGROUND
  • 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.

    PMID: 24073114BACKGROUND
  • 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.

    PMID: 23730803BACKGROUND
  • 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.

    PMID: 26557703BACKGROUND
  • 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.

    PMID: 20604695BACKGROUND
  • 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.

    PMID: 27463067BACKGROUND
  • 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.

    PMID: 27517968BACKGROUND
  • 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.

    PMID: 25419230BACKGROUND
  • 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.

    PMID: 20668923BACKGROUND
  • 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.

    PMID: 25046131BACKGROUND
  • 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.

    PMID: 26569133BACKGROUND
  • Elliot D, Kuehl K, DeFrancesco C, McGinnis W, Ek S, Van Horne A, Kempany KG. Technology-Enabled Intervention to Enhance Mindfulness, Safety, and Health Promotion Among Corrections Professionals: Protocol for a Prospective Quasi-Experimental Trial. JMIR Res Protoc. 2023 Sep 22;12:e45535. doi: 10.2196/45535.

Related Links

MeSH Terms

Conditions

Occupational StressHealth Behavior

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Kerry S. Kuehl, MD, DrPH

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerry S. Kuehl, MD, Dr.PH

CONTACT

Carol Defrancesco, MALS, RDN, LD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine, Section Chief, and Director of Human Performance Laboratory

Study Record Dates

First Submitted

October 25, 2022

First Posted

November 8, 2022

Study Start

November 9, 2022

Primary Completion

September 30, 2023

Study Completion

December 31, 2023

Last Updated

February 14, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations