- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01279941
Safety & Health Improvement: Enhancing Law Enforcement Departments (SHIELD)
Study Overview
Status
Conditions
Intervention / Treatment
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
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:
- member of a participating Law Enforcement Organization
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
|
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
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
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
Investigators
- Principal Investigator: Kerry S Kuehl, MD, PhD, 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
- 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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