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Trial record 19 of 491 for:    Harvard

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 : March 20, 2018
Sponsor:
Collaborators:
Robert Wood Johnson Foundation
National Institute on Aging (NIA)
Abdul Latif Jameel Poverty Action Lab
Zirui Song, Harvard Medical School
Information provided by (Responsible Party):
Katherine Baicker, Harvard School of Public Health

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 and aided by innovative technologies, and will include financial rewards for participation. The program will be available to employees in 25 of BJ's 200 worksites. These sites have been randomly selected, allowing a randomized controlled 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 sites.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16000 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
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : January 2020

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.



Primary Outcome Measures :
  1. 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

  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. 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

  2. Depression [ Time Frame: Primary data collected at 18 months and 30 months after initiation of intervention ]
    Indicator for scoring >=3 on the Patient Health Questionnaire-2 (PHQ2), 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. 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

  6. 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

  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 ]
    Affirmative success in stress management, as indicated in responses to survey questions



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, 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
  Study Documents (Full-Text)

Documents provided by Katherine Baicker, Harvard School of Public Health:

Responsible Party: Katherine Baicker, C. Boyden Gray Professor of Health Economics, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT03167658     History of Changes
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    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
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 Katherine Baicker, Harvard School of Public Health:
Wellness
Prevention

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes