- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02098603
Health Protection & Promotion for Oregon Correctional Officers (DOC HEALTH)
Studieoversigt
Status
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97239
- Oregon Health and Science University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- security employee of a participating facility in the Oregon Department of Corrections
Exclusion Criteria:
- none
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Kun test
|
|
|
Eksperimentel: Test & Intervention
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Kerry S Kuehl, MD, DrPH, Oregon Health and Science University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- e7925
- U19OH010154 (U.S. NIH-bevilling/kontrakt)
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