NCT02098603

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 30, 2015

Status Verified

October 1, 2015

Enrollment Period

1.6 years

First QC Date

October 7, 2013

Last Update Submit

October 28, 2015

Conditions

Physical ActivityNutritionHealth PromotionStress, PsychologicalMetabolic Syndrome

Outcome Measures

Primary Outcomes (7)

  • Change from baseline in BMI at 6 and 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

    questionnaire, NCI fruit/vegetables (Thompson et al., 2002)

    Baseline, 6 months, 12 months

  • Change from baseline in Physical Activity at 6 and 12 months

    questionnaire; Elliot et al., 2007

    Baseline, 6 months, 12 months

  • 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

  • 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

  • Change from baseline in Alcohol Use at 6 and 12 months

    questionnaire

    Baseline, 6 months, 12 months

  • Change from baseline in Tobacco Use at 6 and 12 months

    questionnaire; study specific development

    Baseline, 6 months, 12 months

Secondary Outcomes (5)

  • Change from baseline in Blood Pressure at 6 and 12 months

    Baseline, 6 months, 12 months

  • Change from baseline in Percent Body Fat at 6 and 12 months

    Baseline, 6 months, 12 months

  • Change from baseline in Lipids and Lipoproteins at 6 and 12 months

    Baseline, 6 months, 12 months

  • Change from baseline in Glucose at 6 and 12 months

    Baseline, 6 months, 12 months

  • Cost-Effective Analysis

    12 months

Study Arms (2)

Testing Only

NO INTERVENTION

Testing & Intervention

EXPERIMENTAL
Behavioral: Testing & Intervention

Interventions

Testing & InterventionBEHAVIORAL

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.

Testing & Intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Motor ActivityStress, PsychologicalMetabolic Syndrome

Interventions

Methods

Condition Hierarchy (Ancestors)

BehaviorBehavioral SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Kerry S Kuehl, MD, DrPH

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

October 7, 2013

First Posted

March 28, 2014

Study Start

January 1, 2013

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

October 30, 2015

Record last verified: 2015-10

Locations

US(1)