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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02098603
Other study ID # e7925
Secondary ID U19OH010154
Status Completed
Phase N/A
First received October 7, 2013
Last updated October 28, 2015
Start date January 2013
Est. completion date September 2014

Study information

Verified date October 2015
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

More than 530,000 individuals work as US Correctional Officers (COs) responsible for overseeing the approximately 1.6 million offenders who are incarcerated at any given time in the United States. Prison work is regarded as one of the most difficult occupations with CO's having one of the highest nonfatal injury rates of all U.S. occupations. The few studies done on CO's show high levels of stress, cardiovascular disease, high job burnout, increased sick leave rates and absenteeism, and decreased quality of life leading to premature illness/injury and high employer healthcare costs. Many of these conditions could be prevented by specific training activities and healthier lifestyles. The investigators wish to test a worksite-based, health promotion curriculum in COs with the overall hypothesis that the program will improve health and decrease injuries. The program proposed would be the first occupational intervention to improve the safety, and emotional and physical health of those who are charged with the complex task of prison work protecting the investigators communities. If successful, this proposal would result in an exportable, practical occupational safety and health program applicable for use by local, state, and federal correctional facilities.


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.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date September 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- security employee of a participating facility in the Oregon Department of Corrections

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Behavioral:
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.

Locations

Country Name City State
United States Oregon Health and Science University Portland Oregon

Sponsors (3)

Lead Sponsor Collaborator
Oregon Health and Science University National Institute for Occupational Safety and Health (NIOSH/CDC), Oregon Healthy Workforce Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in BMI at 6 and 12 months calculation of direct measurement of height and weight Baseline, 6 months, 12 months No
Primary Change from baseline in Fruit and Vegetable Intake at 6 and 12 months questionnaire, NCI fruit/vegetables (Thompson et al., 2002) Baseline, 6 months, 12 months No
Primary Change from baseline in Physical Activity at 6 and 12 months questionnaire; Elliot et al., 2007 Baseline, 6 months, 12 months No
Primary Change from baseline in Stress at 6 and 12 months questionnaire; Netemeyer RG et al, 1996; Cohen et al., 1983; Stanton et al, 2001 Baseline, 6 months, 12 months No
Primary Change from baseline in Sleep at 6 and 12 months questionnaire; Sorenson et al., 2011; Buysee et al., 1989; Buxton et al.; Rajaratnam et al., 2011 Baseline, 6 months, 12 months No
Primary Change from baseline in Alcohol Use at 6 and 12 months questionnaire Baseline, 6 months, 12 months No
Primary Change from baseline in Tobacco Use at 6 and 12 months questionnaire; study specific development Baseline, 6 months, 12 months No
Secondary Change from baseline in Blood Pressure at 6 and 12 months direct measurement Baseline, 6 months, 12 months No
Secondary Change from baseline in Percent Body Fat at 6 and 12 months direct measurement via Bioelectric Impedance Analysis scale Baseline, 6 months, 12 months No
Secondary Change from baseline in Lipids and Lipoproteins at 6 and 12 months direct measurement via Cholestech LDX analyzer Baseline, 6 months, 12 months No
Secondary Change from baseline in Glucose at 6 and 12 months direct measurement via Cholestech LDX analyzer Baseline, 6 months, 12 months No
Secondary Cost-Effective Analysis analysis of departmental aggregate data of injury rates and workers compensation claims 12 months No
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