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The Impact of Employee Wellness Programs

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ClinicalTrials.gov Identifier: NCT03167658
Recruitment Status : Active, not recruiting
First Posted : May 30, 2017
Last Update Posted : January 7, 2021
Sponsor:
Collaborators:
Robert Wood Johnson Foundation
National Institute on Aging (NIA)
Abdul Latif Jameel Poverty Action Lab
University of Chicago
Information provided by (Responsible Party):
Zirui Song, Harvard Medical School

Tracking Information
First Submitted Date  ICMJE May 23, 2017
First Posted Date  ICMJE May 30, 2017
Last Update Posted Date January 7, 2021
Actual Study Start Date  ICMJE January 2015
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2020)
  • Physical activity [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
    Regular exercise, number of hours sitting per day, and actively managing weight, as indicated in responses to survey questions
  • Obesity [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
    Body Mass Index>=30, calculated from measured height and weight
  • Absenteeism [ Time Frame: Administrative records from 3 years spanning intervention ]
    Number of sick or personal days as a share of total days employed, from employment records
  • Health care spending [ Time Frame: Administrative records from 3 years spanning intervention ]
    Dollars spent on health care for employees covered by employer-sponsored insurance, from claims records
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
  • Physical activity [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
    Number of days per week of moderate or vigorous exercise, as indicated in responses to survey questions
  • Obesity [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
    Body Mass Index>=30, calculated from measured height and weight
  • Absenteeism [ Time Frame: Administrative records from 3 years spanning intervention ]
    Number of sick or personal days as a share of total days employed, from employment records
  • Health care spending [ Time Frame: Administrative records from 3 years spanning intervention ]
    Dollars spent on health care for employees covered by employer-sponsored insurance, from claims records
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: January 9, 2020)
  • Blood pressure [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
    Systolic blood pressure, measured
  • Depression [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
    Unmanaged depression, as indicated in responses to survey questions
  • Tenure [ Time Frame: Administrative records from 3 years spanning intervention ]
    Duration of employment in days, from employment records
  • Job performance [ Time Frame: Administrative records from 3 years spanning intervention ]
    Numerical performance rating from annual review, from employment records
  • Health care spending (i.e. dollars spent) [ Time Frame: Administrative records from 3 years spanning intervention ]
    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
  • Health care utilization (i.e. number of doctor visits, hospitalizations, or medications) [ Time Frame: Administrative records from 3 years spanning intervention ]
    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
  • Nutrition management [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
    Affirmative engagement in active efforts to improve nutrition, as indicated in responses to survey questions
  • Stress management [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
    Unmanaged stress and stress at work, as indicated in responses to survey questions
  • Screenings and exams [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
    Percent of recommended tests received, as indicated in responses to survey questions
  • Tobacco use [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
    Smoking, as indicated in responses to survey questions
  • Health and wellbeing [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
    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.
  • Blood glucose [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
    Blood glucose, measured
  • Cholesterol [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
    Total cholesterol and high-density lipoprotein (HDL), measured
Original Other Pre-specified Outcome Measures
 (submitted: May 24, 2017)
  • Hypertension [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
    Measured systolic blood pressure >= 140 OR diastolic blood pressure >= 90, measured
  • Depression [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
    Indicator for scoring >=3 on PHQ2 questionnaire, as indicated in responses to survey questions
  • Tenure [ Time Frame: Administrative records from 3 years spanning intervention ]
    Duration of employment in days, from employment records
  • Job performance [ Time Frame: Administrative records from 3 years spanning intervention ]
    Numerical performance rating from annual review, from employment records
  • Detailed health care spending [ Time Frame: Administrative records from 3 years spanning intervention ]
    Dollars spent on health care for employees covered by employer-sponsored insurance, decomposed into spending on inpatient, outpatient, emergency department, and prescription drugs, from claims records
  • Detailed health care utilization [ Time Frame: Administrative records from 3 years spanning intervention ]
    Number of health care encounters for employees covered by employer-sponsored insurance, decomposed into inpatient, outpatient, emergency department, and prescription drugs, from claims records
  • Nutrition management [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
    Affirmative engagement in active efforts to improve nutrition, as indicated in responses to survey questions
  • Stress management [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
    Affirmative success in stress management, as indicated in responses to survey questions
 
Descriptive Information
Brief Title  ICMJE The Impact of Employee Wellness Programs
Official Title  ICMJE The Impact of Employee Wellness Programs
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Each worksite (and all employees at that site) randomly assigned to Treatment or Control arm.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Health Behavior
  • Disease, Chronic
Intervention  ICMJE Behavioral: Workplace wellness program
Multi-prong workplace wellness program, with components such as nutrition counseling, fitness challenges, and stress management workshops, including supports and incentives.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Workplace wellness program
  • No Intervention: 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.
  • No Intervention: 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.
Publications * Song Z, Baicker K. Effect of a Workplace Wellness Program on Employee Health and Economic Outcomes: A Randomized Clinical Trial. JAMA. 2019 Apr 16;321(15):1491-1501. doi: 10.1001/jama.2019.3307. Erratum in: JAMA. 2019 Apr 17;:.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 8, 2020)
48664
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2017)
16000
Estimated Study Completion Date  ICMJE June 2021
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03167658
Other Study ID Numbers  ICMJE Wellness 14-3141
R01AG050329 ( U.S. NIH Grant/Contract )
P30AG012810 ( U.S. NIH Grant/Contract )
72611 ( Other Grant/Funding Number: Robert Wood Johnson Foundation )
AEARCTR-0000586 ( Registry Identifier: American Economic Association Trial Registry )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zirui Song, Harvard Medical School
Study Sponsor  ICMJE Harvard School of Public Health
Collaborators  ICMJE
  • Robert Wood Johnson Foundation
  • National Institute on Aging (NIA)
  • Abdul Latif Jameel Poverty Action Lab
  • University of Chicago
Investigators  ICMJE
Principal Investigator: Zirui Song, MD, PhD Harvard Medical School
PRS Account Harvard School of Public Health
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP