- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02098603
Health Protection & Promotion for Oregon Correctional Officers (DOC HEALTH)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Oregon
-
Portland, Oregon, Vereinigte Staaten, 97239
- Oregon Health and Science University
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- security employee of a participating facility in the Oregon Department of Corrections
Exclusion Criteria:
- none
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: Nur zum Testen
|
|
|
Experimental: Tests und 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from baseline in BMI at 6 and 12 months
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline, 6 months, 12 months
|
questionnaire
|
Baseline, 6 months, 12 months
|
|
Change from baseline in Tobacco Use at 6 and 12 months
Zeitfenster: Baseline, 6 months, 12 months
|
questionnaire; study specific development
|
Baseline, 6 months, 12 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from baseline in Blood Pressure at 6 and 12 months
Zeitfenster: Baseline, 6 months, 12 months
|
direct measurement
|
Baseline, 6 months, 12 months
|
|
Change from baseline in Percent Body Fat at 6 and 12 months
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline, 6 months, 12 months
|
direct measurement via Cholestech LDX analyzer
|
Baseline, 6 months, 12 months
|
|
Cost-Effective Analysis
Zeitfenster: 12 months
|
analysis of departmental aggregate data of injury rates and workers compensation claims
|
12 months
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Kerry S Kuehl, MD, DrPH, Oregon Health and Science University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- e7925
- U19OH010154 (US NIH Stipendium/Vertrag)
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