Physical ActivitySHIELDNCT01279941
Safety & Health Improvement: Enhancing Law Enforcement Departments
A study testing Behavioral: Team-based intervention in people with Physical Activity and Nutrition, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Nutrition, Health Promotion
- What is being tested?
- Behavioral: Team-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 489 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- member of a participating Law Enforcement Organization
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
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.
Read the 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.
- Conditions
- Physical Activity, Nutrition, Health Promotion, Stress, Psychological, Cardiovascular Diseases, Cancer
- Being tested
- Behavioral: Team-based intervention
- Medical subject headings
- Motor Activity, Stress, Psychological, Cardiovascular Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Team-based interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Testing Only | No intervention | Not described |
| Testing & Intervention | Experimental | Not described Receives: Behavioral: Behavioral: Team-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Measured: January 2011-Dec 2014
Fruit and Vegetable Intake
Measured: January 2011-Dec 2014
Physical Activity
Measured: January 2011-Dec 2014
Stress
Measured: January 2011-Dec 2014
Sleep
Measured: January 2011-Dec 2014
Alcohol Use
Measured: January 2011-Dec 2014
Tobacco Use
Measured: January 2011-Dec 2014
Secondary outcomes (6)
Blood Pressure
Measured: January 2011-Dec 2014
Percent Body Fat
Measured: January 2011-Dec 2014
Lipids and Lipoproteins
Measured: January 2011-Dec 2014
Glucose
Measured: January 2011-Dec 2014
Fasting Insulin
Measured: January 2011-Dec 2014
Cost-Effective Analysis
Measured: January 2011-Dec 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startAug 2010
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 489 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Principal investigator, Kerry Kuehl, Oregon Health and Science University
- Investigators
- Kerry S Kuehl, MD, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279941
- Sponsor's protocol ID
- e6309
- Acronym
- SHIELD
- Status last verified
- Oct 2015
- First submitted
- 19 Jan 2011
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety & Health Improvement: Enhancing Law Enforcement Departments
- ClinicalTrials.gov ID
- NCT01279941
- Acronym / sponsor ID
- SHIELD / e6309
- Conditions
- Physical Activity, Nutrition, Health Promotion, Stress, Psychological, Cardiovascular Diseases, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- Aug 2010
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testing Only | No intervention | – |
| Testing & Intervention | Experimental | Behavioral: Behavioral: Team-based intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- member of a participating Law Enforcement Organization
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral: Team-based interventionThe 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. | Behavioural | Testing & Intervention |
Primary outcome
BMI
Time frame: January 2011-Dec 2014
Fruit and Vegetable Intake
Time frame: January 2011-Dec 2014
Physical Activity
Time frame: January 2011-Dec 2014
Stress
Time frame: January 2011-Dec 2014
Sleep
Time frame: January 2011-Dec 2014
Alcohol Use
Time frame: January 2011-Dec 2014
Tobacco Use
Time frame: January 2011-Dec 2014
6 secondary outcomes
Blood Pressure
Time frame: January 2011-Dec 2014
Percent Body Fat
Time frame: January 2011-Dec 2014
Lipids and Lipoproteins
Time frame: January 2011-Dec 2014
Glucose
Time frame: January 2011-Dec 2014
Fasting Insulin
Time frame: January 2011-Dec 2014
Cost-Effective Analysis
Time frame: January 2011-Dec 2014
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerry S Kuehl, MD, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: Team-based intervention in people with Physical Activity and Nutrition, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: January 2011-Dec 2014). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2015.