- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02098603
Health Protection & Promotion for Oregon Correctional Officers (DOC HEALTH)
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Oregon
-
Portland, Oregon, Forente stater, 97239
- Oregon Health and Science University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- security employee of a participating facility in the Oregon Department of Corrections
Exclusion Criteria:
- none
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Kun testing
|
|
|
Eksperimentell: Testing og intervensjon
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in BMI at 6 and 12 months
Tidsramme: Baseline, 6 months, 12 months
|
calculation of direct measurement of height and weight
|
Baseline, 6 months, 12 months
|
|
Change from baseline in Fruit and Vegetable Intake at 6 and 12 months
Tidsramme: Baseline, 6 months, 12 months
|
questionnaire, NCI fruit/vegetables (Thompson et al., 2002)
|
Baseline, 6 months, 12 months
|
|
Change from baseline in Physical Activity at 6 and 12 months
Tidsramme: Baseline, 6 months, 12 months
|
questionnaire; Elliot et al., 2007
|
Baseline, 6 months, 12 months
|
|
Change from baseline in Stress at 6 and 12 months
Tidsramme: Baseline, 6 months, 12 months
|
questionnaire; Netemeyer RG et al, 1996; Cohen et al., 1983; Stanton et al, 2001
|
Baseline, 6 months, 12 months
|
|
Change from baseline in Sleep at 6 and 12 months
Tidsramme: Baseline, 6 months, 12 months
|
questionnaire; Sorenson et al., 2011; Buysee et al., 1989; Buxton et al.; Rajaratnam et al., 2011
|
Baseline, 6 months, 12 months
|
|
Change from baseline in Alcohol Use at 6 and 12 months
Tidsramme: Baseline, 6 months, 12 months
|
questionnaire
|
Baseline, 6 months, 12 months
|
|
Change from baseline in Tobacco Use at 6 and 12 months
Tidsramme: Baseline, 6 months, 12 months
|
questionnaire; study specific development
|
Baseline, 6 months, 12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in Blood Pressure at 6 and 12 months
Tidsramme: Baseline, 6 months, 12 months
|
direct measurement
|
Baseline, 6 months, 12 months
|
|
Change from baseline in Percent Body Fat at 6 and 12 months
Tidsramme: Baseline, 6 months, 12 months
|
direct measurement via Bioelectric Impedance Analysis scale
|
Baseline, 6 months, 12 months
|
|
Change from baseline in Lipids and Lipoproteins at 6 and 12 months
Tidsramme: Baseline, 6 months, 12 months
|
direct measurement via Cholestech LDX analyzer
|
Baseline, 6 months, 12 months
|
|
Change from baseline in Glucose at 6 and 12 months
Tidsramme: Baseline, 6 months, 12 months
|
direct measurement via Cholestech LDX analyzer
|
Baseline, 6 months, 12 months
|
|
Cost-Effective Analysis
Tidsramme: 12 months
|
analysis of departmental aggregate data of injury rates and workers compensation claims
|
12 months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Kerry S Kuehl, MD, DrPH, Oregon Health and Science University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- e7925
- U19OH010154 (U.S. NIH-stipend/kontrakt)
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