Physical ActivityDOC HEALTHNCT02098603
Health Protection & Promotion for Oregon Correctional Officers
A study testing Testing & Intervention in people with Physical Activity and Nutrition, run by Oregon Health and Science University at 1 site in United States.
Trial summary
More than 530,000 individuals work as US Correctional Officers (COs) responsible for overseeing the approximately 1.6 million offenders who are incarcerated at any given time in the United States. 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?
- Testing & Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Sep 2014
- 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
- security employee of a participating facility in the Oregon Department of Corrections
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
More than 530,000 individuals work as US Correctional Officers (COs) responsible for overseeing the approximately 1.6 million offenders who are incarcerated at any given time in the United States. Prison work is regarded as one of the most difficult occupations with CO's having one of the highest nonfatal injury rates of all U.S. occupations. The few studies done on CO's show high levels of stress, cardiovascular disease, high job burnout, increased sick leave rates and absenteeism, and decreased quality of life leading to premature illness/injury and high employer healthcare costs. Many of these conditions could be prevented by specific training activities and healthier lifestyles. The investigators wish to test a worksite-based, health promotion curriculum in COs with the overall hypothesis that the program will improve health and decrease injuries. The program proposed would be the first occupational intervention to improve the safety, and emotional and physical health of those who are charged with the complex task of prison work protecting the investigators communities. If successful, this proposal would result in an exportable, practical occupational safety and health program applicable for use by local, state, and federal correctional facilities.
Read the detailed description
Investigators will enroll up to 100 Correctional Officers from four Oregon Department of Corrections facilities for a randomized controlled 1-year assessment of the intervention. Participants will be evaluated at baseline, 6, and 12 months.
Primary study aims are; 1) Implement a randomized controlled efficacy trial of the Team-centered health promotion intervention, and assess its behavioral and occupational outcomes among COs, 2) Perform a cost analysis to determine the potential economic impact of this CO worksite health promotion program on illness/injury rates and disability claims, and 3) Determine relationships among specific intervention components with changes to behavior and occupational outcomes and assess by mediation analysis.
The intervention involves a scripted peer-taught interactive curriculum, which is delivered as twelve, 30 minute weekly sessions incorporated into a team's usual work time activities. 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 and law enforcement, along with adaptations for the needs of Correctional Officers 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 COs. Its critical components will be defined, and its benefits clearly determined.
- Being tested
- Testing & Intervention
- Medical subject headings
- Motor Activity, Stress, Psychological, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing & InterventionBehavioural
Intervention involves a scripted peer-taught interactive curriculum, which is delivered as twelve, 30 minute weekly sessions incorporated into a team's usual work time or overtime activities.
| Study group | Role | What they receive |
|---|---|---|
| Testing Only | No intervention | Not described |
| Testing & Intervention | Experimental | Not described Receives: Behavioral: Testing & Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in BMI at 6 and 12 months
calculation of direct measurement of height and weight
Measured: Baseline, 6 months, 12 months
Change from baseline in Fruit and Vegetable Intake at 6 and 12 months
questionnaire, NCI fruit/vegetables (Thompson et al., 2002)
Measured: Baseline, 6 months, 12 months
Change from baseline in Physical Activity at 6 and 12 months
questionnaire; Elliot et al., 2007
Measured: Baseline, 6 months, 12 months
Change from baseline in Stress at 6 and 12 months
questionnaire; Netemeyer RG et al, 1996; Cohen et al., 1983; Stanton et al, 2001
Measured: Baseline, 6 months, 12 months
Change from baseline in Sleep at 6 and 12 months
questionnaire; Sorenson et al., 2011; Buysee et al., 1989; Buxton et al.; Rajaratnam et al., 2011
Measured: Baseline, 6 months, 12 months
Change from baseline in Alcohol Use at 6 and 12 months
questionnaire
Measured: Baseline, 6 months, 12 months
Change from baseline in Tobacco Use at 6 and 12 months
questionnaire; study specific development
Measured: Baseline, 6 months, 12 months
Secondary outcomes (5)
Change from baseline in Blood Pressure at 6 and 12 months
direct measurement
Measured: Baseline, 6 months, 12 months
Change from baseline in Percent Body Fat at 6 and 12 months
direct measurement via Bioelectric Impedance Analysis scale
Measured: Baseline, 6 months, 12 months
Change from baseline in Lipids and Lipoproteins at 6 and 12 months
direct measurement via Cholestech LDX analyzer
Measured: Baseline, 6 months, 12 months
Change from baseline in Glucose at 6 and 12 months
direct measurement via Cholestech LDX analyzer
Measured: Baseline, 6 months, 12 months
Cost-Effective Analysis
analysis of departmental aggregate data of injury rates and workers compensation claims
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startJan 2013
- Primary completionAug 2014
- Study completionSep 2014
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
- 86 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), Oregon Healthy Workforce Center
- Responsible party
- Principal investigator, Kerry Kuehl, Oregon Health and Science University
- Investigators
- Kerry S Kuehl, MD, DrPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098603
- Sponsor's protocol ID
- e7925
- Other IDs
- U19OH010154
- Acronym
- DOC HEALTH
- Status last verified
- Oct 2015
- First submitted
- 7 Oct 2013
- 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
- Health Protection & Promotion for Oregon Correctional Officers
- ClinicalTrials.gov ID
- NCT02098603
- Acronym / sponsor ID
- DOC HEALTH / e7925
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC), Oregon Healthy Workforce Center
- Study start
- Jan 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 28 Mar 2014 (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.
More than 530,000 individuals work as US Correctional Officers (COs) responsible for overseeing the approximately 1.6 million offenders who are incarcerated at any given time in the United States. Prison work is regarded as one of the most difficult occupations with CO's having one of the highest nonfatal injury rates of all U.S. occupations. The few studies done on CO's show high levels of stress, cardiovascular disease, high job burnout, increased sick leave rates and absenteeism, and decreased quality of life leading to premature illness/injury and high employer healthcare costs. Many of these conditions could be prevented by specific training activities and healthier lifestyles. The investigators wish to test a worksite-based, health promotion curriculum in COs with the overall hypothesis that the program will improve health and decrease injuries. The program proposed would be the first occupational intervention to improve the safety, and emotional and physical health of those who are charged with the complex task of prison work protecting the investigators communities. If successful, this proposal would result in an exportable, practical occupational safety and health program applicable for use by local, state, and federal correctional facilities.
Detailed description
Investigators will enroll up to 100 Correctional Officers from four Oregon Department of Corrections facilities for a randomized controlled 1-year assessment of the intervention. Participants will be evaluated at baseline, 6, and 12 months.
Primary study aims are; 1) Implement a randomized controlled efficacy trial of the Team-centered health promotion intervention, and assess its behavioral and occupational outcomes among COs, 2) Perform a cost analysis to determine the potential economic impact of this CO worksite health promotion program on illness/injury rates and disability claims, and 3) Determine relationships among specific intervention components with changes to behavior and occupational outcomes and assess by mediation analysis.
The intervention involves a scripted peer-taught interactive curriculum, which is delivered as twelve, 30 minute weekly sessions incorporated into a team's usual work time activities. 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 and law enforcement, along with adaptations for the needs of Correctional Officers 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 COs. 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: Testing & Intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- security employee of a participating facility in the Oregon Department of Corrections
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 |
|---|---|---|
| Testing & InterventionIntervention involves a scripted peer-taught interactive curriculum, which is delivered as twelve, 30 minute weekly sessions incorporated into a team's usual work time or overtime activities. | Behavioural | Testing & Intervention |
Primary outcome
Change from baseline in BMI at 6 and 12 months
Time frame: Baseline, 6 months, 12 months
calculation of direct measurement of height and weight
Change from baseline in Fruit and Vegetable Intake at 6 and 12 months
Time frame: Baseline, 6 months, 12 months
questionnaire, NCI fruit/vegetables (Thompson et al., 2002)
Change from baseline in Physical Activity at 6 and 12 months
Time frame: Baseline, 6 months, 12 months
questionnaire; Elliot et al., 2007
Change from baseline in Stress at 6 and 12 months
Time frame: Baseline, 6 months, 12 months
questionnaire; Netemeyer RG et al, 1996; Cohen et al., 1983; Stanton et al, 2001
Change from baseline in Sleep at 6 and 12 months
Time frame: Baseline, 6 months, 12 months
questionnaire; Sorenson et al., 2011; Buysee et al., 1989; Buxton et al.; Rajaratnam et al., 2011
Change from baseline in Alcohol Use at 6 and 12 months
Time frame: Baseline, 6 months, 12 months
questionnaire
Change from baseline in Tobacco Use at 6 and 12 months
Time frame: Baseline, 6 months, 12 months
questionnaire; study specific development
5 secondary outcomes
Change from baseline in Blood Pressure at 6 and 12 months
Time frame: Baseline, 6 months, 12 months
Change from baseline in Percent Body Fat at 6 and 12 months
Time frame: Baseline, 6 months, 12 months
Change from baseline in Lipids and Lipoproteins at 6 and 12 months
Time frame: Baseline, 6 months, 12 months
Change from baseline in Glucose at 6 and 12 months
Time frame: Baseline, 6 months, 12 months
Cost-Effective Analysis
Time frame: 12 months
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, DrPH 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 Testing & 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?
Change from baseline in BMI at 6 and 12 months (time frame: Baseline, 6 months, 12 months). 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.