NCT03167658

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48,664

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

3.8 years

First QC Date

May 23, 2017

Last Update Submit

September 7, 2021

Conditions

Keywords

WellnessPrevention

Outcome Measures

Primary Outcomes (4)

  • Physical activity

    Regular exercise, number of hours sitting per day, and actively managing weight, as indicated in responses to survey questions

    Primary data collected at 18 months and 30 months after initiation of intervention

  • Obesity

    Body Mass Index\>=30, calculated from measured height and weight

    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

    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

    Administrative records from 3 years spanning intervention

Other Outcomes (13)

  • Blood pressure

    Primary data collected at 18 months and 30 months after initiation of intervention

  • Depression

    Primary data collected at 18 months and 30 months after initiation of intervention

  • Tenure

    Administrative records from 3 years spanning intervention

  • +10 more other outcomes

Study Arms (3)

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.

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.

Interventions

Multi-prong workplace wellness program, with components such as nutrition counseling, fitness challenges, and stress management workshops, including supports and incentives.

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Employed in one of BJ's clubs during the period of the intervention

You may not qualify if:

  • Not employed in one of BJ's clubs during the period of the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Health BehaviorChronic Disease

Condition Hierarchy (Ancestors)

BehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zirui Song, MD, PhD

    Harvard Medical School (HMS and HSDM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Each worksite (and all employees at that site) randomly assigned to Treatment or Control arm.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Health Care Policy and Medicine

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 30, 2017

Study Start

January 1, 2015

Primary Completion

October 1, 2018

Study Completion

June 1, 2021

Last Updated

September 9, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share