Safety & Health Improvement: Enhancing Law Enforcement Departments (SHIELD)

October 28, 2015 updated by: Kerry Kuehl, Oregon Health and Science University
Researchers from Oregon Health & Science University have developed a science-based, team-centered, scripted peer-taught program for fire fighters improving diet and exercise behavior while reducing injury rates and costs. Those investigators are partnering with local law enforcement agencies in Oregon and SW Washington to adapt, apply and assess this work-based program among a new high risk group to improve the health and safety of law enforcement officers (LEOs). Fire fighters' work structure is a natural fit for a team-centered format, and teammates' social support appeared to partially mediate the intervention's positive outcomes. Although conducive to team formation, LEOs' work lacks the established team structure of fire fighters. This proposal will apply the team-centered intervention to LEOs and in the process, learn more about teams as vehicles of health behavior change, and their relationship with outcomes and other potential mediating variables in a multilevel ecological analytic framework.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Following a 3 month pilot study with four teams, we will enroll 14 precincts and 80 teams (approximately 470 participants) of LEO work groups for a prospective, clustered randomized 2-year assessment of the intervention (40 intervention and 40 testing-only, control-condition teams). Participants will be evaluated at baseline, 12, and 24. Primary study aims are; 1) Implement a randomized controlled efficacy trial of the SHIELD intervention, a peer-led, team-based occupational wellness program, and assess its behavioral and occupational outcomes, 2) Determine relations among variables in the chain from exposure of LEO subjects to specific intervention components to changes in mediating variables to behavior changes and occupational outcomes, and 3) Perform a cost analysis to determine the economic benefit of this LEO worksite health promotion program.

The intervention involves a scripted peer-taught interactive curriculum, which is delivered as twelve, one-hour weekly sessions incorporated into a team's usual work time activities, with four follow-up booster sessions after twelve months. 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, along with adaptations for the needs of LEOs 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 LEOs. Its critical components will be defined, and its benefits clearly determined.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
489

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • member of a participating Law Enforcement Organization

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Testing Only
Experimental: Testing & Intervention
Behavioral: Behavioral: Team-based intervention
The intervention involves a scripted peer-taught interactive curriculum, which is delivered as twelve, one-hour weekly sessions incorporated into a team's usual work time activities, with four follow-up booster sessions after twelve months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
BMI
Time Frame: January 2011-Dec 2014
January 2011-Dec 2014
Fruit and Vegetable Intake
Time Frame: January 2011-Dec 2014
January 2011-Dec 2014
Physical Activity
Time Frame: January 2011-Dec 2014
January 2011-Dec 2014
Stress
Time Frame: January 2011-Dec 2014
January 2011-Dec 2014
Sleep
Time Frame: January 2011-Dec 2014
January 2011-Dec 2014
Alcohol Use
Time Frame: January 2011-Dec 2014
January 2011-Dec 2014
Tobacco Use
Time Frame: January 2011-Dec 2014
January 2011-Dec 2014

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Blood Pressure
Time Frame: January 2011-Dec 2014
January 2011-Dec 2014
Percent Body Fat
Time Frame: January 2011-Dec 2014
January 2011-Dec 2014
Lipids and Lipoproteins
Time Frame: January 2011-Dec 2014
January 2011-Dec 2014
Glucose
Time Frame: January 2011-Dec 2014
January 2011-Dec 2014
Fasting Insulin
Time Frame: January 2011-Dec 2014
January 2011-Dec 2014
Cost-Effective Analysis
Time Frame: January 2011-Dec 2014
January 2011-Dec 2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Health and Science University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute for Occupational Safety and Health (NIOSH/CDC)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kerry S Kuehl, MD, PhD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • e6309

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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