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

This study has been completed.
Sponsor:
Collaborators:
Office of Behavioral and Science Sciences Research
William T. Grant Foundation
Alfred P Sloan Foundation
Administration for Children and Families
Information provided by (Responsible Party):
Lisa Berkman, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT02050204
First received: January 28, 2014
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Focus of Study: Work Conditions
Behavioral: Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Evaluating the Health Benefits of Workplace Policies and Practices - Phase II

Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • Change in total sleep time [ Time Frame: baseline to one year later ] [ Designated as safety issue: No ]
    Average 24 hour total sleep time as assessed by ~1 week of actigraphy

  • change in wake after sleep onset [ Time Frame: baseline to one year later ] [ Designated as safety issue: No ]
    Amount of nightime wake after sleep onset as assessed by ~1 week of actigraphy

  • change in cardiometabolic risk score [ Time Frame: baseline to one year later ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • change in sleep insufficiency [ Time Frame: baseline to one year later ] [ Designated as safety issue: No ]

    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


  • change in insomnia symptoms [ Time Frame: baseline to one year later ] [ Designated as safety issue: No ]

    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



Enrollment: 2753
Study Start Date: September 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: 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).
No Intervention: LEEF Industry only: Usual Practice
Continued work conditions and practice as "Usual Practice" in that workplace
Experimental: 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.
Behavioral: 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).
No Intervention: TOMO Industry only: Usual Practice
Continued work conditions and practice as "Usual Practice" in that workplace

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02050204

Locations
United States, Massachusetts
Harvard School of Public Health
Cambridge, Massachusetts, United States, 02318
Sponsors and Collaborators
Harvard School of Public Health
Office of Behavioral and Science Sciences Research
William T. Grant Foundation
Alfred P Sloan Foundation
Administration for Children and Families
Investigators
Principal Investigator: Lisa F Berkman, PhD Harvard School of Public Health
Principal Investigator: Orfeu M Buxton, PhD Brigham and Women's Hospital; Harvard Medical School; Harvard School of Public Health; Pennsylvania State University
  More Information

Publications:

Responsible Party: Lisa Berkman, Professor, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT02050204     History of Changes
Other Study ID Numbers: P16633, U01AG027669, U01HD051218, U01HD051256, U01HD051276, U01HD051217, R01HL107240, U01OH008788, U01HD059773
Study First Received: January 28, 2014
Last Updated: January 29, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Institutional Review Board

Keywords provided by Harvard School of Public Health:
work to family conflict
supervisor support
long work hours
cardiometabolic risk
sleep duration
insomnia symptoms

ClinicalTrials.gov processed this record on October 16, 2014