Safety & Health Improvement: Enhancing Law Enforcement Departments

Cancer Clinical Trial

— SHIELD  

Official title:

Safety & Health Improvement: Enhancing Law Enforcement Departments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279941
• Other study ID #: e6309
• Status: Completed
• Phase: N/A
• First received: January 19, 2011
• Last updated: October 28, 2015
• Start date: August 2010
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 489
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• member of a participating Law Enforcement Organization

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer
• Cardiovascular Diseases
• Health Promotion
• Nutrition
• Physical Activity
• Stress, Psychological

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.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Institute for Occupational Safety and Health (NIOSH/CDC)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI		January 2011-Dec 2014	No
Primary	Fruit and Vegetable Intake		January 2011-Dec 2014	No
Primary	Physical Activity		January 2011-Dec 2014	No
Primary	Stress		January 2011-Dec 2014	No
Primary	Sleep		January 2011-Dec 2014	No
Primary	Alcohol Use		January 2011-Dec 2014	No
Primary	Tobacco Use		January 2011-Dec 2014	No
Secondary	Blood Pressure		January 2011-Dec 2014	No
Secondary	Percent Body Fat		January 2011-Dec 2014	No
Secondary	Lipids and Lipoproteins		January 2011-Dec 2014	No
Secondary	Glucose		January 2011-Dec 2014	No
Secondary	Fasting Insulin		January 2011-Dec 2014	No
Secondary	Cost-Effective Analysis		January 2011-Dec 2014	No