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- Klinische proef NCT03167658
The Impact of Employee Wellness Programs
7 september 2021 bijgewerkt door: Zirui Song, Harvard School of Public Health (HSPH)
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
48664
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
Multi-prong workplace wellness program, with components such as nutrition counseling, fitness challenges, and stress management workshops, including supports and incentives.
|
|
Geen tussenkomst: 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.
|
|
|
Geen tussenkomst: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Physical activity
Tijdsspanne: 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
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
|
Obesity
Tijdsspanne: Primary data collected at 18 months and 30 months after initiation of intervention
|
Body Mass Index>=30, calculated from measured height and weight
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
|
Absenteeism
Tijdsspanne: Administrative records from 3 years spanning intervention
|
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
Tijdsspanne: Administrative records from 3 years spanning intervention
|
Dollars spent on health care for employees covered by employer-sponsored insurance, from claims records
|
Administrative records from 3 years spanning intervention
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Blood pressure
Tijdsspanne: Primary data collected at 18 months and 30 months after initiation of intervention
|
Systolic blood pressure, measured
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
|
Depression
Tijdsspanne: Primary data collected at 18 months and 30 months after initiation of intervention
|
Unmanaged depression, as indicated in responses to survey questions
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
|
Tenure
Tijdsspanne: Administrative records from 3 years spanning intervention
|
Duration of employment in days, from employment records
|
Administrative records from 3 years spanning intervention
|
|
Job performance
Tijdsspanne: Administrative records from 3 years spanning intervention
|
Numerical performance rating from annual review, from employment records
|
Administrative records from 3 years spanning intervention
|
|
Health care spending (i.e. dollars spent)
Tijdsspanne: 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
|
Administrative records from 3 years spanning intervention
|
|
Health care utilization (i.e. number of doctor visits, hospitalizations, or medications)
Tijdsspanne: 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
|
Administrative records from 3 years spanning intervention
|
|
Nutrition management
Tijdsspanne: 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
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
|
Stress management
Tijdsspanne: 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
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
|
Screenings and exams
Tijdsspanne: 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
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
|
Tobacco use
Tijdsspanne: Primary data collected at 18 months and 30 months after initiation of intervention
|
Smoking, as indicated in responses to survey questions
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
|
Health and wellbeing
Tijdsspanne: 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.
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
|
Blood glucose
Tijdsspanne: Primary data collected at 18 months and 30 months after initiation of intervention
|
Blood glucose, measured
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
|
Cholesterol
Tijdsspanne: Primary data collected at 18 months and 30 months after initiation of intervention
|
Total cholesterol and high-density lipoprotein (HDL), measured
|
Primary data collected at 18 months and 30 months after initiation of intervention
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Zirui Song, MD, PhD, Harvard Medical School (HMS and HSDM)
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2015
Primaire voltooiing (Werkelijk)
1 oktober 2018
Studie voltooiing (Werkelijk)
1 juni 2021
Studieregistratiedata
Eerst ingediend
23 mei 2017
Eerst ingediend dat voldeed aan de QC-criteria
24 mei 2017
Eerst geplaatst (Werkelijk)
30 mei 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 september 2021
Laatste update ingediend die voldeed aan QC-criteria
7 september 2021
Laatst geverifieerd
1 september 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Wellness 14-3141
- R01AG050329 (Subsidie/contract van de Amerikaanse NIH)
- P30AG012810 (Subsidie/contract van de Amerikaanse NIH)
- 72611 (Ander subsidie-/financieringsnummer: Robert Wood Johnson Foundation)
- AEARCTR-0000586 (Register-ID: American Economic Association Trial Registry)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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