- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03167658
The Impact of Employee Wellness Programs
2021년 9월 7일 업데이트: Zirui Song, Harvard School of Public Health (HSPH)
There is great public and private interest in the use of workplace wellness programs to reduce health care spending, improve health outcomes, and enhance productivity for employees.
However, there is little rigorous evidence on the effects of wellness programs.
This study partners with a large multi-state U.S. employer (BJ's Wholesale Club) and an experienced wellness vendor (Wellness Workdays) to evaluate a multi-prong workplace wellness program, including components such as nutrition counseling, fitness challenges, and stress management workshops.
The wellness program will be delivered by a team of experts including Registered Dieticians, and will include financial rewards for participation.
The program will be available to employees in initially 20 of BJ's 200 worksites, and later expanded to 25 worksites.
These worksites have been randomly selected, allowing a randomized controlled trial evaluation of the effects of the wellness program.
Data will be collected on a wide array of outcomes from multiple sources, including on-site biometric screenings and surveys, employment records, and health insurance claims for employees at both treatment and control worksites.
연구 개요
연구 유형
중재적
등록 (실제)
48664
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Employed in one of BJ's clubs during the period of the intervention
Exclusion Criteria:
- Not employed in one of BJ's clubs during the period of the intervention
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Treatment
Employees at treatment worksites will be given access to workplace wellness programming.
Participation by employees will be voluntary, but all employees at treatment sites will be considered as part of the treatment group.
Employees will also be invited to complete on-site biometric assessments and questionnaires.
Data from secondary data sources (including employment records and health insurance claims) will be collected for employees at all BJ's worksites.
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Multi-prong workplace wellness program, with components such as nutrition counseling, fitness challenges, and stress management workshops, including supports and incentives.
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간섭 없음: Primary Control
Employees at primary control worksites will be invited to complete on-site biometric assessments and questionnaires, but will not have access to the workplace wellness programming.
Data from secondary data sources (including employment records and health insurance claims) will be collected for employees at all BJ's worksites.
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간섭 없음: Secondary Control
Employees at secondary control worksites will not participate in in-person screenings or questionnaires, and will not have access to workplace wellness programming.
Data from secondary data sources (including employment records and health insurance claims) will be collected for employees at all BJ's worksites.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Physical activity
기간: Primary data collected at 18 months and 30 months after initiation of intervention
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Regular exercise, number of hours sitting per day, and actively managing weight, as indicated in responses to survey questions
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Primary data collected at 18 months and 30 months after initiation of intervention
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Obesity
기간: Primary data collected at 18 months and 30 months after initiation of intervention
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Body Mass Index>=30, calculated from measured height and weight
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Primary data collected at 18 months and 30 months after initiation of intervention
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Absenteeism
기간: Administrative records from 3 years spanning intervention
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Number of sick or personal days as a share of total days employed, from employment records
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Administrative records from 3 years spanning intervention
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Health care spending
기간: Administrative records from 3 years spanning intervention
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Dollars spent on health care for employees covered by employer-sponsored insurance, from claims records
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Administrative records from 3 years spanning intervention
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Blood pressure
기간: Primary data collected at 18 months and 30 months after initiation of intervention
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Systolic blood pressure, measured
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Primary data collected at 18 months and 30 months after initiation of intervention
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Depression
기간: Primary data collected at 18 months and 30 months after initiation of intervention
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Unmanaged depression, as indicated in responses to survey questions
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Primary data collected at 18 months and 30 months after initiation of intervention
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Tenure
기간: Administrative records from 3 years spanning intervention
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Duration of employment in days, from employment records
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Administrative records from 3 years spanning intervention
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Job performance
기간: Administrative records from 3 years spanning intervention
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Numerical performance rating from annual review, from employment records
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Administrative records from 3 years spanning intervention
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Health care spending (i.e. dollars spent)
기간: Administrative records from 3 years spanning intervention
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Dollars spent on health care and prescription drugs for employees covered by employer-sponsored insurance, decomposed into spending on inpatient, outpatient, emergency department, and prescription drugs, from claims records
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Administrative records from 3 years spanning intervention
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Health care utilization (i.e. number of doctor visits, hospitalizations, or medications)
기간: Administrative records from 3 years spanning intervention
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Health care encounters and prescription drugs for employees covered by employer-sponsored insurance, decomposed into inpatient, outpatient, emergency department, and prescription drugs, from claims records
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Administrative records from 3 years spanning intervention
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Nutrition management
기간: Primary data collected at 18 months and 30 months after initiation of intervention
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Affirmative engagement in active efforts to improve nutrition, as indicated in responses to survey questions
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Primary data collected at 18 months and 30 months after initiation of intervention
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Stress management
기간: Primary data collected at 18 months and 30 months after initiation of intervention
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Unmanaged stress and stress at work, as indicated in responses to survey questions
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Primary data collected at 18 months and 30 months after initiation of intervention
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Screenings and exams
기간: Primary data collected at 18 months and 30 months after initiation of intervention
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Percent of recommended tests received, as indicated in responses to survey questions
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Primary data collected at 18 months and 30 months after initiation of intervention
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Tobacco use
기간: Primary data collected at 18 months and 30 months after initiation of intervention
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Smoking, as indicated in responses to survey questions
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Primary data collected at 18 months and 30 months after initiation of intervention
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Health and wellbeing
기간: Primary data collected at 18 months and 30 months after initiation of intervention
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Short form 8 (SF-8) physical and mental summary scores, as indicated in responses to survey questions.
Each question of the SF-8 uses a 5- or 6-point Likert scale.
Its standardized scoring system combines responses into a score that can be interpreted as a continuous variable (analogous to a 0-100 scale), with higher scores denoting better self-reported health.
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Primary data collected at 18 months and 30 months after initiation of intervention
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Blood glucose
기간: Primary data collected at 18 months and 30 months after initiation of intervention
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Blood glucose, measured
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Primary data collected at 18 months and 30 months after initiation of intervention
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Cholesterol
기간: Primary data collected at 18 months and 30 months after initiation of intervention
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Total cholesterol and high-density lipoprotein (HDL), measured
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Primary data collected at 18 months and 30 months after initiation of intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Zirui Song, MD, PhD, Harvard Medical School (HMS and HSDM)
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2015년 1월 1일
기본 완료 (실제)
2018년 10월 1일
연구 완료 (실제)
2021년 6월 1일
연구 등록 날짜
최초 제출
2017년 5월 23일
QC 기준을 충족하는 최초 제출
2017년 5월 24일
처음 게시됨 (실제)
2017년 5월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 9월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 9월 7일
마지막으로 확인됨
2021년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Wellness 14-3141
- R01AG050329 (미국 NIH 보조금/계약)
- P30AG012810 (미국 NIH 보조금/계약)
- 72611 (기타 보조금/기금 번호: Robert Wood Johnson Foundation)
- AEARCTR-0000586 (레지스트리 식별자: American Economic Association Trial Registry)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
건강 행동에 대한 임상 시험
-
University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH) 그리고 다른 협력자들완전한
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University of Dublin, Trinity College알려지지 않은Brain Health 은퇴 엘리트 선수
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Seattle Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH) 그리고 다른 협력자들아직 모집하지 않음
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University아직 모집하지 않음Focus Health 임산부
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University College London HospitalsUniversity College, London완전한
-
Gümüşhane UniversıtyKaradeniz Technical University완전한Kelkit District State Hospital Home Health Unit에 등록 | 가정 간호 환자칠면조
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University of Haifa완전한산후 기간 | 산모 정신 건강 | Parenting / Maternal Behavior | 초산 (첫 아이를 임신한 산모) | 산후 우울 증상이스라엘
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The Mediterranean Institute for the Advance of...Carlos III Health Institute; European Regional Development Fund; Andalusian Regional Ministry... 그리고 다른 협력자들아직 모집하지 않음
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Hopital MontfortChildren's Hospital of Eastern Ontario Research Institute모병열 스트레스 장애 | 1차 의료 | 환경 노출 | 위험 감소 행동 | 공중 위생 | 열 노출 | 기후 변화 | 예방 건강 서비스(PREV HEALTH SERV) | 건강한 과목캐나다
Workplace wellness program에 대한 임상 시험
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Children's Hospital Medical Center, CincinnatiNational Institute of Mental Health (NIMH)완전한
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Chang Gung University of Science and Technology아직 모집하지 않음
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Cornell UniversityNational Institute on Minority Health and Health Disparities (NIMHD); Weill Medical College...완전한
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AdventHealthState of Florida Department of Health모병
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University of California, Los AngelesUniversity of California, Davis; California Department of Health Services완전한
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Yale UniversityPatient-Centered Outcomes Research Institute완전한정신 건강 웰니스 1 | 정신 질환 | 기타 진단, 합병증 및 합병증 | 인내심 있는미국
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Endourage, LLC완전한긴 COVID | 긴 Covid19 | 포스트 급성 COVID-19 | 장거리 COVID | 장거리 COVID-19 | COVID-19 후 증후군미국
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University of Texas Southwestern Medical CenterNational Institute on Minority Health and Health Disparities (NIMHD)초대로 등록