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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03167658
Other study ID # Wellness 14-3141
Secondary ID R01AG050329P30AG
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date June 2021

Study information

Verified date September 2021
Source Harvard School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 48664
Est. completion date June 2021
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
Harvard School of Public Health Abdul Latif Jameel Poverty Action Lab, National Institute on Aging (NIA), Robert Wood Johnson Foundation, University of Chicago

Outcome

Type Measure Description Time frame Safety issue
Other Blood pressure Systolic blood pressure, measured Primary data collected at 18 months and 30 months after initiation of intervention
Other Depression Unmanaged depression, as indicated in responses to survey questions Primary data collected at 18 months and 30 months after initiation of intervention
Other Tenure Duration of employment in days, from employment records Administrative records from 3 years spanning intervention
Other Job performance Numerical performance rating from annual review, from employment records Administrative records from 3 years spanning intervention
Other Health care spending (i.e. dollars spent) 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 Administrative records from 3 years spanning intervention
Other Health care utilization (i.e. number of doctor visits, hospitalizations, or medications) 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 Administrative records from 3 years spanning intervention
Other Nutrition management Affirmative engagement in active efforts to improve nutrition, as indicated in responses to survey questions Primary data collected at 18 months and 30 months after initiation of intervention
Other Stress management Unmanaged stress and stress at work, as indicated in responses to survey questions Primary data collected at 18 months and 30 months after initiation of intervention
Other Screenings and exams Percent of recommended tests received, as indicated in responses to survey questions Primary data collected at 18 months and 30 months after initiation of intervention
Other Tobacco use Smoking, as indicated in responses to survey questions Primary data collected at 18 months and 30 months after initiation of intervention
Other Health and wellbeing 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. Primary data collected at 18 months and 30 months after initiation of intervention
Other Blood glucose Blood glucose, measured Primary data collected at 18 months and 30 months after initiation of intervention
Other Cholesterol Total cholesterol and high-density lipoprotein (HDL), measured Primary data collected at 18 months and 30 months after initiation of intervention
Primary 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
Primary Obesity Body Mass Index>=30, calculated from measured height and weight Primary data collected at 18 months and 30 months after initiation of intervention
Primary Absenteeism Number of sick or personal days as a share of total days employed, from employment records Administrative records from 3 years spanning intervention
Primary 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
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