Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kerry Kuehl, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01279941
First received: January 19, 2011
Last updated: October 14, 2014
Last verified: October 2013
  Purpose

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.


Condition Intervention
Physical Activity
Nutrition
Health Promotion
Stress, Psychological
Cardiovascular Diseases
Cancer
Behavioral: Behavioral: Team-based intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety & Health Improvement: Enhancing Law Enforcement Departments

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • BMI [ Time Frame: January 2011-Dec 2014 ] [ Designated as safety issue: No ]
  • Fruit and Vegetable Intake [ Time Frame: January 2011-Dec 2014 ] [ Designated as safety issue: No ]
  • Physical Activity [ Time Frame: January 2011-Dec 2014 ] [ Designated as safety issue: No ]
  • Stress [ Time Frame: January 2011-Dec 2014 ] [ Designated as safety issue: No ]
  • Sleep [ Time Frame: January 2011-Dec 2014 ] [ Designated as safety issue: No ]
  • Alcohol Use [ Time Frame: January 2011-Dec 2014 ] [ Designated as safety issue: No ]
  • Tobacco Use [ Time Frame: January 2011-Dec 2014 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: January 2011-Dec 2014 ] [ Designated as safety issue: No ]
  • Percent Body Fat [ Time Frame: January 2011-Dec 2014 ] [ Designated as safety issue: No ]
  • Lipids and Lipoproteins [ Time Frame: January 2011-Dec 2014 ] [ Designated as safety issue: No ]
  • Glucose [ Time Frame: January 2011-Dec 2014 ] [ Designated as safety issue: No ]
  • Fasting Insulin [ Time Frame: January 2011-Dec 2014 ] [ Designated as safety issue: No ]
  • Cost-Effective Analysis [ Time Frame: January 2011-Dec 2014 ] [ Designated as safety issue: No ]

Estimated Enrollment: 470
Study Start Date: August 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • member of a participating Law Enforcement Organization

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279941

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Kerry S Kuehl, MD, PhD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Kerry Kuehl, Associate Professor of Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01279941     History of Changes
Other Study ID Numbers: e6309
Study First Received: January 19, 2011
Last Updated: October 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 25, 2014