Safety & Health Improvement: Enhancing Law Enforcement Departments (SHIELD)
Primary Purpose
Physical Activity, Nutrition, Health Promotion
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral: Team-based intervention
Sponsored by
About this trial
This is an interventional prevention trial for Physical Activity
Eligibility Criteria
Inclusion Criteria:
- member of a participating Law Enforcement Organization
Exclusion Criteria:
- none
Sites / Locations
- Oregon Health and Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Testing Only
Testing & Intervention
Arm Description
Outcomes
Primary Outcome Measures
BMI
Fruit and Vegetable Intake
Physical Activity
Stress
Sleep
Alcohol Use
Tobacco Use
Secondary Outcome Measures
Blood Pressure
Percent Body Fat
Lipids and Lipoproteins
Glucose
Fasting Insulin
Cost-Effective Analysis
Full Information
NCT ID
NCT01279941
First Posted
January 19, 2011
Last Updated
October 28, 2015
Sponsor
Oregon Health and Science University
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)
1. Study Identification
Unique Protocol Identification Number
NCT01279941
Brief Title
Safety & Health Improvement: Enhancing Law Enforcement Departments
Acronym
SHIELD
Official Title
Safety & Health Improvement: Enhancing Law Enforcement Departments
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Nutrition, Health Promotion, Stress, Psychological, Cardiovascular Diseases, Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
489 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Testing Only
Arm Type
No Intervention
Arm Title
Testing & Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Behavioral: Team-based intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
BMI
Time Frame
January 2011-Dec 2014
Title
Fruit and Vegetable Intake
Time Frame
January 2011-Dec 2014
Title
Physical Activity
Time Frame
January 2011-Dec 2014
Title
Stress
Time Frame
January 2011-Dec 2014
Title
Sleep
Time Frame
January 2011-Dec 2014
Title
Alcohol Use
Time Frame
January 2011-Dec 2014
Title
Tobacco Use
Time Frame
January 2011-Dec 2014
Secondary Outcome Measure Information:
Title
Blood Pressure
Time Frame
January 2011-Dec 2014
Title
Percent Body Fat
Time Frame
January 2011-Dec 2014
Title
Lipids and Lipoproteins
Time Frame
January 2011-Dec 2014
Title
Glucose
Time Frame
January 2011-Dec 2014
Title
Fasting Insulin
Time Frame
January 2011-Dec 2014
Title
Cost-Effective Analysis
Time Frame
January 2011-Dec 2014
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
member of a participating Law Enforcement Organization
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry S Kuehl, MD, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
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Safety & Health Improvement: Enhancing Law Enforcement Departments
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