- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02098603
Health Protection & Promotion for Oregon Correctional Officers (DOC HEALTH)
Study Overview
Status
Intervention / Treatment
Detailed Description
Investigators will enroll up to 100 Correctional Officers from four Oregon Department of Corrections facilities for a randomized controlled 1-year assessment of the intervention. Participants will be evaluated at baseline, 6, and 12 months.
Primary study aims are; 1) Implement a randomized controlled efficacy trial of the Team-centered health promotion intervention, and assess its behavioral and occupational outcomes among COs, 2) Perform a cost analysis to determine the potential economic impact of this CO worksite health promotion program on illness/injury rates and disability claims, and 3) Determine relationships among specific intervention components with changes to behavior and occupational outcomes and assess by mediation analysis.
The intervention involves a scripted peer-taught interactive curriculum, which is delivered as twelve, 30 minute weekly sessions incorporated into a team's usual work time activities. The curriculum is designed to build understanding, healthy decision making skills and engender the social support of teammates; its content and scope reflects the core lifestyles activities used with fire fighters and law enforcement, along with adaptations for the needs of Correctional Officers in domains of the team-building, family support and psychological health.
Participant assessments include established survey instruments, physiological measures and selected laboratory parameters of outcomes and potential mediating variables at the individual, interpersonal and organizational levels. Intervention delivery and fidelity will be assessed. Multilevel and latent growth modeling and mediation analyses will be used to assess outcomes and the relationships among variables. At proposal completion there will be an evidenced-based, exportable occupational safety and health program for COs. Its critical components will be defined, and its benefits clearly determined.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health and Science University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- security employee of a participating facility in the Oregon Department of Corrections
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Testing Only
|
|
Experimental: Testing & Intervention
|
Intervention involves a scripted peer-taught interactive curriculum, which is delivered as twelve, 30 minute weekly sessions incorporated into a team's usual work time or overtime activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in BMI at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
|
calculation of direct measurement of height and weight
|
Baseline, 6 months, 12 months
|
Change from baseline in Fruit and Vegetable Intake at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
|
questionnaire, NCI fruit/vegetables (Thompson et al., 2002)
|
Baseline, 6 months, 12 months
|
Change from baseline in Physical Activity at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
|
questionnaire; Elliot et al., 2007
|
Baseline, 6 months, 12 months
|
Change from baseline in Stress at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
|
questionnaire; Netemeyer RG et al, 1996; Cohen et al., 1983; Stanton et al, 2001
|
Baseline, 6 months, 12 months
|
Change from baseline in Sleep at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
|
questionnaire; Sorenson et al., 2011; Buysee et al., 1989; Buxton et al.; Rajaratnam et al., 2011
|
Baseline, 6 months, 12 months
|
Change from baseline in Alcohol Use at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
|
questionnaire
|
Baseline, 6 months, 12 months
|
Change from baseline in Tobacco Use at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
|
questionnaire; study specific development
|
Baseline, 6 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Blood Pressure at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
|
direct measurement
|
Baseline, 6 months, 12 months
|
Change from baseline in Percent Body Fat at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
|
direct measurement via Bioelectric Impedance Analysis scale
|
Baseline, 6 months, 12 months
|
Change from baseline in Lipids and Lipoproteins at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
|
direct measurement via Cholestech LDX analyzer
|
Baseline, 6 months, 12 months
|
Change from baseline in Glucose at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
|
direct measurement via Cholestech LDX analyzer
|
Baseline, 6 months, 12 months
|
Cost-Effective Analysis
Time Frame: 12 months
|
analysis of departmental aggregate data of injury rates and workers compensation claims
|
12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kerry S Kuehl, MD, DrPH, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
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
- e7925
- U19OH010154 (U.S. NIH Grant/Contract)
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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