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

13 dicembre 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

2753

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Massachusetts
      • Cambridge, Massachusetts, Stati Uniti, 02318
        • Harvard School of Public Health

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
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).
Nessun intervento: LEEF Industry only: Usual Practice
Continued work conditions and practice as "Usual Practice" in that workplace
Sperimentale: 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.
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).
Nessun intervento: TOMO Industry only: Usual Practice
Continued work conditions and practice as "Usual Practice" in that workplace

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in total sleep time
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
change in sleep insufficiency
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2009

Completamento primario (Effettivo)

1 dicembre 2012

Completamento dello studio (Effettivo)

1 dicembre 2012

Date di iscrizione allo studio

Primo inviato

28 gennaio 2014

Primo inviato che soddisfa i criteri di controllo qualità

29 gennaio 2014

Primo Inserito (Stima)

30 gennaio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 dicembre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 dicembre 2017

Ultimo verificato

1 dicembre 2017

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • P16633
  • U01AG027669 (Sovvenzione/contratto NIH degli Stati Uniti)
  • U01HD051218 (Sovvenzione/contratto NIH degli Stati Uniti)
  • U01HD051256 (Sovvenzione/contratto NIH degli Stati Uniti)
  • U01HD051276 (Sovvenzione/contratto NIH degli Stati Uniti)
  • U01HD051217 (Sovvenzione/contratto NIH degli Stati Uniti)
  • R01HL107240 (Sovvenzione/contratto NIH degli Stati Uniti)
  • U01OH008788 (Sovvenzione/contratto NIH degli Stati Uniti)
  • U01HD059773 (Sovvenzione/contratto NIH degli Stati Uniti)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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