- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02098603
Health Protection & Promotion for Oregon Correctional Officers (DOC HEALTH)
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Oregon
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Portland, Oregon, 미국, 97239
- Oregon Health and Science University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- security employee of a participating facility in the Oregon Department of Corrections
Exclusion Criteria:
- none
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: 테스트 전용
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실험적: 테스트 및 개입
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in BMI at 6 and 12 months
기간: Baseline, 6 months, 12 months
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calculation of direct measurement of height and weight
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Baseline, 6 months, 12 months
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Change from baseline in Fruit and Vegetable Intake at 6 and 12 months
기간: Baseline, 6 months, 12 months
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questionnaire, NCI fruit/vegetables (Thompson et al., 2002)
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Baseline, 6 months, 12 months
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Change from baseline in Physical Activity at 6 and 12 months
기간: Baseline, 6 months, 12 months
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questionnaire; Elliot et al., 2007
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Baseline, 6 months, 12 months
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Change from baseline in Stress at 6 and 12 months
기간: Baseline, 6 months, 12 months
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questionnaire; Netemeyer RG et al, 1996; Cohen et al., 1983; Stanton et al, 2001
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Baseline, 6 months, 12 months
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Change from baseline in Sleep at 6 and 12 months
기간: Baseline, 6 months, 12 months
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questionnaire; Sorenson et al., 2011; Buysee et al., 1989; Buxton et al.; Rajaratnam et al., 2011
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Baseline, 6 months, 12 months
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Change from baseline in Alcohol Use at 6 and 12 months
기간: Baseline, 6 months, 12 months
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questionnaire
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Baseline, 6 months, 12 months
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Change from baseline in Tobacco Use at 6 and 12 months
기간: Baseline, 6 months, 12 months
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questionnaire; study specific development
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Baseline, 6 months, 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in Blood Pressure at 6 and 12 months
기간: Baseline, 6 months, 12 months
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direct measurement
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Baseline, 6 months, 12 months
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Change from baseline in Percent Body Fat at 6 and 12 months
기간: Baseline, 6 months, 12 months
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direct measurement via Bioelectric Impedance Analysis scale
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Baseline, 6 months, 12 months
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Change from baseline in Lipids and Lipoproteins at 6 and 12 months
기간: Baseline, 6 months, 12 months
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direct measurement via Cholestech LDX analyzer
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Baseline, 6 months, 12 months
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Change from baseline in Glucose at 6 and 12 months
기간: Baseline, 6 months, 12 months
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direct measurement via Cholestech LDX analyzer
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Baseline, 6 months, 12 months
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Cost-Effective Analysis
기간: 12 months
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analysis of departmental aggregate data of injury rates and workers compensation claims
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12 months
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Kerry S Kuehl, MD, DrPH, Oregon Health and Science University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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