The Impact of Employee Wellness Programs

• ClinicalTrials.gov Identifier: NCT03167658
• Recruitment Status: Completed
• First Posted: May 30, 2017
• Last Update Posted: September 9, 2021
• Sponsor: Harvard School of Public Health (HSPH)
• 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 (HMS and HSDM)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Health Behavior; Disease, Chronic	Behavioral: Workplace wellness program	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48664 participants
• 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
• Official Title: The Impact of Employee Wellness Programs
• Actual Study Start Date: January 2015
• Actual Primary Completion Date: October 2018
• Actual Study Completion Date: June 2021

Arms and Interventions

Arm	Intervention/treatment
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.	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.
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.

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. 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
4. 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

Other Outcome Measures:

1. Blood pressure [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
   Systolic blood pressure, measured
2. 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
3. Tenure [ Time Frame: Administrative records from 3 years spanning intervention ]
   Duration of employment in days, from employment records
4. Job performance [ Time Frame: Administrative records from 3 years spanning intervention ]
   Numerical performance rating from annual review, from employment records
5. 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
6. 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
7. 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
8. 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
9. 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
10. 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
11. 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.
12. Blood glucose [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
    Blood glucose, measured
13. Cholesterol [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
    Total cholesterol and high-density lipoprotein (HDL), measured

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Harvard School of Public Health (HSPH)

Robert Wood Johnson Foundation

National Institute on Aging (NIA)

Abdul Latif Jameel Poverty Action Lab

University of Chicago

Investigators

• Principal Investigator: Zirui Song, MD, PhD; Harvard Medical School (HMS and HSDM)

  Study Documents (Full-Text)

Documents provided by Zirui Song, Harvard Medical School (HMS and HSDM):

Study Protocol and Statistical Analysis Plan  [PDF] January 7, 2020

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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;:

• Responsible Party: Zirui Song, Assistant Professor of Health Care Policy and Medicine, Harvard Medical School (HMS and HSDM)
• ClinicalTrials.gov Identifier: NCT03167658
• Other Study ID Numbers: 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 )
• First Posted: May 30, 2017
• Last Update Posted: September 9, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zirui Song, Harvard Medical School (HMS and HSDM):

Wellness; Prevention

Additional relevant MeSH terms:

Chronic Disease; Disease Attributes; Pathologic Processes