Clinical trial NCT02050204: Evaluating the Health Benefits of Workplace Policies and Practices - Phase II
Official title: Evaluating the Health Benefits of Workplace Policies and Practices - Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus of Study: Work Conditions
Keywords: work to family conflict
supervisor support
long work hours
cardiometabolic risk
sleep duration
insomnia symptoms
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Heart, Lung, and Blood Institute (NHLBI)
name: Office of Behavioral and Social Sciences Research (OBSSR)
name: National Institute for Occupational Safety and Health (NIOSH/CDC)
First posted: 2014-01-30
Enrollment: 2753
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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 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

Primary outcomes:
measure: Change in total sleep time
timeFrame: baseline to one year later
measure: change in wake after sleep onset
timeFrame: baseline to one year later
measure: change in cardiometabolic risk score
timeFrame: baseline to one year later
Secondary outcomes:
measure: change in sleep insufficiency
timeFrame: baseline to one year later
measure: change in insomnia symptoms
timeFrame: baseline to one year later
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Harvard School of Public Health
state: Massachusetts
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Lisa F Berkman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital; Harvard Medical School; Harvard School of Public Health; Pennsylvania State University
name: Orfeu M Buxton, PhD
role: PRINCIPAL_INVESTIGATOR
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