Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Evaluating the Health Benefits of Workplace Policies and Practices - Phase II (WFHS)

13. desember 2017 oppdatert av: Lisa Berkman, Harvard School of Public Health (HSPH)
Although the prevalence of "family-friendly" policies in US workplaces has increased dramatically, few have been studied using scientifically sound designs. To address this, the NIH and CDC formed the Work, Family, and Health Network (WFHN). During Phase 1, the WFHN designed and conducted multiple pilot and feasibility studies. For Phase 2, the WFHN implemented an innovative intervention based on Phase I pilot studies that is designed to increase family-supportive supervisor behaviors and employee control over work, and to evaluate the intervention using a group randomized experimental design. Customized interventions were performed separately in workplaces of two separate corporate partners.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Although the prevalence of "family-friendly" policies in US workplaces has increased dramatically in recent years, few have been studied using scientifically sound designs. To address this critical gap, the NIH and CDC formed the Work, Family, and Health Network (WFHN). During Phase 1, the WFHN designed and conducted multiple pilot and feasibility studies.

For Phase 2, the WFHN implemented an innovative intervention based on Phase 1 pilot studies that is designed to increase family-supportive supervisor behaviors and employee control over work, and to evaluate the intervention using a group randomized experimental design. The goal of the study is to assess the effects of a workplace intervention designed to reduce work-family conflict, and thereby improve the health and well being of employees. The study intervention is grounded in theory from multiple disciplines and supported by findings from pilot/feasibility studies. The study seeks to inform the implementation of evidence-based, family-friendly policies, and thereby improving the health and well-being of employees and their families nationwide.

The investigators assess the efficacy of the intervention via two independent, group-randomized field experiments, one at each of two employers representing different industries, referred to by alias as "LEEF" and "TOMO". LEEF is an extended care (nursing home) company and facilities were excluded if they were in very isolated settings, if there were fewer than 30 direct patient-care employees, or if facilities were recently acquired. TOMO is an Information Technology company. Within each industry partner, worksites of 50-120 employees each were randomly assigned to intervention or usual practice conditions. All employee and supervisor participants were assessed at baseline and at 6-, 12-, and 18-months post baseline, including survey interviews and health assessments.

Primary health outcomes were comprised of a cardiometabolic risk score using selected biomarkers and sleep duration and quality objectively measured using wrist actigraphy. These primary health outcomes were independently assessed as change from baseline to the 12-month wave, and separately in the two industries.

Studietype

Intervensjonell

Registrering (Faktiske)

2753

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Massachusetts
      • Cambridge, Massachusetts, Forente stater, 02318
        • Harvard School of Public Health

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • LEEF: employees and supervisors with at least 22 weekly hours of direct patient care work in selected facilities
  • TOMO: employees and supervisors located in the two data collection cities

Exclusion Criteria:

  • LEEF: nightwork schedule
  • TOMO: independent contractor classification

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: LEEF Industry only: Intervention
Customized to the "Leef" (alias) workplace: A 3-month structural and social change process designed to increase employee control over work time and family supportive supervisory behaviors.
Atferdsmessig: Intervention
The intervention was a 3-month structural and social change process designed to increase employee control over work time and family supportive supervisory behaviors (Kossek et al., in press). The change process was an integration of two previously evaluated interventions (Hammer et al., 2011; Kelly et al., 2011). A facilitator led 8 hrs of participatory sessions to transition employees from a time-based to a results-based work culture. Supervisors participated in all change activities plus 4hrs of training in supportive supervision. Training in family supportive supervision was implemented with behavioral computer-based training (cTRAIN, NWeta, Lake Oswego, OR) followed by 2 rounds of goal-setting and behavioral self-monitoring using an iPod Touch (Habitrack, OHSU, Portland, OR).
Ingen inngripen: LEEF Industry only: Usual Practice
Continued work conditions and practice as "Usual Practice" in that workplace
Eksperimentell: TOMO Industry only: Intervention
Customized to the "Tomo" (alias) workplace: A 3-month structural and social change process designed to increase employee control over work time and family supportive supervisory behaviors.
Atferdsmessig: Intervention
The intervention was a 3-month structural and social change process designed to increase employee control over work time and family supportive supervisory behaviors (Kossek et al., in press). The change process was an integration of two previously evaluated interventions (Hammer et al., 2011; Kelly et al., 2011). A facilitator led 8 hrs of participatory sessions to transition employees from a time-based to a results-based work culture. Supervisors participated in all change activities plus 4hrs of training in supportive supervision. Training in family supportive supervision was implemented with behavioral computer-based training (cTRAIN, NWeta, Lake Oswego, OR) followed by 2 rounds of goal-setting and behavioral self-monitoring using an iPod Touch (Habitrack, OHSU, Portland, OR).
Ingen inngripen: TOMO Industry only: Usual Practice
Continued work conditions and practice as "Usual Practice" in that workplace

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in total sleep time
Tidsramme: baseline to one year later
Average 24 hour total sleep time as assessed by ~1 week of actigraphy
baseline to one year later
change in wake after sleep onset
Tidsramme: baseline to one year later
Amount of nightime wake after sleep onset as assessed by ~1 week of actigraphy
baseline to one year later
change in cardiometabolic risk score
Tidsramme: baseline to one year later
The cardiometabolic risk score was created based on modifiable risk factors using an independently validated CVD risk score developed from the Framingham offspring study; including BMI, blood pressure, HbA1C, cholesterol, and tobacco consumption.
baseline to one year later

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
change in sleep insufficiency
Tidsramme: baseline to one year later

Sleep insufficiency was assessed by the following question: How often during the past 4 weeks did you get enough sleep to feel rested upon waking up? Would you say never, rarely, sometimes, often, or very often?

YES - NEVER/RARELY

NO - SOMETIMES OFTEN VERY OFTEN
baseline to one year later
change in insomnia symptoms
Tidsramme: baseline to one year later

Insomnia symptoms were assessed by the following question: During the past 4 weeks, how often did you wake up in the middle of the night or early morning? (Would you say never, less than once a week, once or twice a week, or three or more times a week?)

YES - THREE OR MORE TIMES A WEEK

NO - NEVER/LESS THAN ONCE A WEEK/ONCE OR TWICE A WEEK
baseline to one year later

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Harvard School of Public Health (HSPH)

Samarbeidspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
National Institute for Occupational Safety and Health (NIOSH/CDC)
Office of Behavioral and Social Sciences Research (OBSSR)

Etterforskere

  • Hovedetterforsker: Lisa F Berkman, PhD, Harvard School of Public Health (HSPH)
  • Hovedetterforsker: Orfeu M Buxton, PhD, Brigham and Women's Hospital; Harvard Medical School; Harvard School of Public Health; Pennsylvania State University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2009

Primær fullføring (Faktiske)

1. desember 2012

Studiet fullført (Faktiske)

1. desember 2012

Datoer for studieregistrering

Først innsendt

28. januar 2014

Først innsendt som oppfylte QC-kriteriene

29. januar 2014

Først lagt ut (Anslag)

30. januar 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. desember 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. desember 2017

Sist bekreftet

1. desember 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • P16633
  • U01AG027669 (U.S. NIH-stipend/kontrakt)
  • U01HD051218 (U.S. NIH-stipend/kontrakt)
  • U01HD051256 (U.S. NIH-stipend/kontrakt)
  • U01HD051276 (U.S. NIH-stipend/kontrakt)
  • U01HD051217 (U.S. NIH-stipend/kontrakt)
  • R01HL107240 (U.S. NIH-stipend/kontrakt)
  • U01OH008788 (U.S. NIH-stipend/kontrakt)
  • U01HD059773 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Intervention

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in China

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere