Health BehaviorNCT03167658
The Impact of Employee Wellness Programs
A study testing Workplace wellness program in people with Health Behavior and Disease, Chronic, run by Harvard School of Public Health (HSPH).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Behavior, Disease, Chronic
- What is being tested?
- Workplace wellness program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48,664 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Employed in one of BJ's clubs during the period of the intervention
Who cannot join
- Not employed in one of BJ's clubs during the period of the intervention
About this study
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.
- Conditions
- Health Behavior, Disease, Chronic
- Being tested
- Workplace wellness program
- Keywords
- Wellness, Prevention
- Medical subject headings
- Health Behavior, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Workplace wellness programBehavioural
Multi-prong workplace wellness program, with components such as nutrition counseling, fitness challenges, and stress management workshops, including supports and incentives.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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. Receives: Behavioral: Workplace wellness program |
| Primary Control | No intervention | 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. |
| Secondary Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Regular exercise, number of hours sitting per day, and actively managing weight, as indicated in responses to survey questions
Measured: Primary data collected at 18 months and 30 months after initiation of intervention
Obesity
Body Mass Index>=30, calculated from measured height and weight
Measured: Primary data collected at 18 months and 30 months after initiation of intervention
Absenteeism
Number of sick or personal days as a share of total days employed, from employment records
Measured: Administrative records from 3 years spanning intervention
Health care spending
Dollars spent on health care for employees covered by employer-sponsored insurance, from claims records
Measured: Administrative records from 3 years spanning intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study startJan 2015
- Primary completionOct 2018
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each worksite (and all employees at that site) randomly assigned to Treatment or Control arm.
- Masking
- None (open label)
- Enrolment
- 48,664 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, National Institute on Aging (NIA), Abdul Latif Jameel Poverty Action Lab, University of Chicago
- Responsible party
- Principal investigator, Zirui Song, Harvard Medical School (HMS and HSDM)
- Investigators
- Zirui Song, MD, PhD, Principal investigator, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167658
- Sponsor's protocol ID
- Wellness 14-3141
- Other IDs
- R01AG050329, P30AG012810, 72611, AEARCTR-0000586
- Status last verified
- Sep 2021
- First submitted
- 23 May 2017
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30990549
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Employee Wellness Programs
- ClinicalTrials.gov ID
- NCT03167658
- Acronym / sponsor ID
- Wellness 14-3141
- Conditions
- Health Behavior, Disease, Chronic
- Keywords
- Wellness, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48,664 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, National Institute on Aging (NIA), Abdul Latif Jameel Poverty Action Lab, University of Chicago
- Study start
- Jan 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Each worksite (and all employees at that site) randomly assigned to Treatment or Control arm.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Workplace wellness programEmployees 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. |
| Primary Control | No intervention | –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. |
| Secondary Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Employed in one of BJ's clubs during the period of the intervention
Key exclusion criteria (1 listed)
- Not employed in one of BJ's clubs during the period of the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Workplace wellness programMulti-prong workplace wellness program, with components such as nutrition counseling, fitness challenges, and stress management workshops, including supports and incentives. | Behavioural | Treatment |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Derived from this study: PubMed 30990549Song 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.
- Individual participant dataSharing planned: No
Related trials for Health Behavior
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health
Recruiting
Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD
Neuromyelitis Optica Spectrum Disorder (NMOSD)
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zirui Song, MD, PhD principal investigator
Harvard Medical School (HMS and HSDM)
Questions about this trial
What is this clinical trial studying?
A study testing Workplace wellness program in people with Health Behavior and Disease, Chronic, run by Harvard School of Public Health (HSPH).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: Primary data collected at 18 months and 30 months after initiation of intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03167658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.