NCT02050204

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,753

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
Last Updated

December 15, 2017

Status Verified

December 1, 2017

Enrollment Period

3.3 years

First QC Date

January 28, 2014

Last Update Submit

December 13, 2017

Conditions

Keywords

work to family conflictsupervisor supportlong work hourscardiometabolic risksleep durationinsomnia symptoms

Outcome Measures

Primary Outcomes (3)

  • Change in total sleep time

    Average 24 hour total sleep time as assessed by \~1 week of actigraphy

    baseline to one year later

  • change in wake after sleep onset

    Amount of nightime wake after sleep onset as assessed by \~1 week of actigraphy

    baseline to one year later

  • change in cardiometabolic risk score

    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

Secondary Outcomes (2)

  • change in sleep insufficiency

    baseline to one year later

  • change in insomnia symptoms

    baseline to one year later

Study Arms (4)

LEEF Industry only: Intervention

EXPERIMENTAL

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

LEEF Industry only: Usual Practice

NO INTERVENTION

Continued work conditions and practice as "Usual Practice" in that workplace

TOMO Industry only: Intervention

EXPERIMENTAL

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

TOMO Industry only: Usual Practice

NO INTERVENTION

Continued work conditions and practice as "Usual Practice" in that workplace

Interventions

InterventionBEHAVIORAL

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).

LEEF Industry only: InterventionTOMO Industry only: Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • LEEF: nightwork schedule
  • TOMO: independent contractor classification

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard School of Public Health

Cambridge, Massachusetts, 02318, United States

Location

Related Publications (25)

  • Okechukwu CA, Souza K, Davis KD, de Castro AB. Discrimination, harassment, abuse, and bullying in the workplace: contribution of workplace injustice to occupational health disparities. Am J Ind Med. 2014 May;57(5):573-86. doi: 10.1002/ajim.22221. Epub 2013 Jun 27.

    PMID: 23813664BACKGROUND
  • Hammer LB, Ernst Kossek E, Bodner T, Crain T. Measurement development and validation of the Family Supportive Supervisor Behavior Short-Form (FSSB-SF). J Occup Health Psychol. 2013 Jul;18(3):285-96. doi: 10.1037/a0032612. Epub 2013 Jun 3.

    PMID: 23730803BACKGROUND
  • Liu S, Rovine MJ, Klein LC, Almeida DM. Synchrony of diurnal cortisol pattern in couples. J Fam Psychol. 2013 Aug;27(4):579-88. doi: 10.1037/a0033735.

    PMID: 23978320BACKGROUND
  • Cunningham TJ, Seeman TE, Kawachi I, Gortmaker SL, Jacobs DR, Kiefe CI, Berkman LF. Racial/ethnic and gender differences in the association between self-reported experiences of racial/ethnic discrimination and inflammation in the CARDIA cohort of 4 US communities. Soc Sci Med. 2012 Sep;75(5):922-31. doi: 10.1016/j.socscimed.2012.04.027. Epub 2012 May 23.

    PMID: 22682683BACKGROUND
  • O'Donnell EM, Berkman LF, Subramanian SV. Manager support for work-family issues and its impact on employee-reported pain in the extended care setting. J Occup Environ Med. 2012 Sep;54(9):1142-9. doi: 10.1097/JOM.0b013e3182554af4.

    PMID: 22892547BACKGROUND
  • Nelson CC, Li Y, Sorensen G, Berkman LF. Assessing the relationship between work-family conflict and smoking. Am J Public Health. 2012 Sep;102(9):1767-72. doi: 10.2105/AJPH.2011.300413. Epub 2012 Jun 21.

    PMID: 22720765BACKGROUND
  • Hurtado DA, Sabbath EL, Ertel KA, Buxton OM, Berkman LF. Racial disparities in job strain among American and immigrant long-term care workers. Int Nurs Rev. 2012 Jun;59(2):237-44. doi: 10.1111/j.1466-7657.2011.00948.x. Epub 2011 Dec 7.

    PMID: 22591096BACKGROUND
  • Sembajwe G, Wahrendorf M, Siegrist J, Sitta R, Zins M, Goldberg M, Berkman L. Effects of job strain on fatigue: cross-sectional and prospective views of the job content questionnaire and effort--reward imbalance in the GAZEL cohort. Occup Environ Med. 2012 Jun;69(6):377-84. doi: 10.1136/oem.2010.063503. Epub 2011 Aug 17.

    PMID: 21849345BACKGROUND
  • Wahrendorf M, Sembajwe G, Zins M, Berkman L, Goldberg M, Siegrist J. Long-term effects of psychosocial work stress in midlife on health functioning after labor market exit--results from the GAZEL study. J Gerontol B Psychol Sci Soc Sci. 2012 Jul;67(4):471-80. doi: 10.1093/geronb/gbs045. Epub 2012 Apr 29.

    PMID: 22546992BACKGROUND
  • Okechukwu CA, El Ayadi AM, Tamers SL, Sabbath EL, Berkman L. Household food insufficiency, financial strain, work-family spillover, and depressive symptoms in the working class: the Work, Family, and Health Network study. Am J Public Health. 2012 Jan;102(1):126-33. doi: 10.2105/AJPH.2011.300323. Epub 2011 Nov 28.

    PMID: 22095360BACKGROUND
  • Sabbath EL, Melchior M, Goldberg M, Zins M, Berkman LF. Work and family demands: predictors of all-cause sickness absence in the GAZEL cohort. Eur J Public Health. 2012 Feb;22(1):101-6. doi: 10.1093/eurpub/ckr041. Epub 2011 May 9.

    PMID: 21558153BACKGROUND
  • McHale SM, Blocklin MK, Walter KN, Davis KD, Almeida DM, Klein LC. The role of daily activities in youths' stress physiology. J Adolesc Health. 2012 Dec;51(6):623-8. doi: 10.1016/j.jadohealth.2012.03.016. Epub 2012 May 16.

    PMID: 23174474BACKGROUND
  • Blocklin MK, Crouter AC, McHale SM. Youth Supervision While Mothers Work: A Daily Diary Study of Maternal Worry. Community Work Fam. 2012;15(2):233-249. doi: 10.1080/13668803.2011.639169. Epub 2011 Dec 2.

    PMID: 23109814BACKGROUND
  • Almeida DM, Davis KD. Workplace Flexibility and Daily Stress Processes in Hotel Employees and their Children. Ann Am Acad Pol Soc Sci. 2011 Nov;638(1):123-140. doi: 10.1177/0002716211415608.

    PMID: 23833321BACKGROUND
  • Hammer LB, Kossek EE, Anger WK, Bodner T, Zimmerman KL. Clarifying work-family intervention processes: the roles of work-family conflict and family-supportive supervisor behaviors. J Appl Psychol. 2011 Jan;96(1):134-50. doi: 10.1037/a0020927.

    PMID: 20853943BACKGROUND
  • Ertel KA, Berkman LF, Buxton OM. Socioeconomic status, occupational characteristics, and sleep duration in African/Caribbean immigrants and US White health care workers. Sleep. 2011 Apr 1;34(4):509-18. doi: 10.1093/sleep/34.4.509.

    PMID: 21461330BACKGROUND
  • O'Donnell EM, Ertel KA, Berkman LF. Depressive symptoms in extended-care employees: children, social support, and work-family conditions. Issues Ment Health Nurs. 2011;32(12):752-65. doi: 10.3109/01612840.2011.609958.

    PMID: 22077748BACKGROUND
  • Ertel KA, Koenen KC, Berkman LF. Incorporating home demands into models of job strain: findings from the work, family, and health network. J Occup Environ Med. 2008 Nov;50(11):1244-52. doi: 10.1097/JOM.0b013e31818c308d.

    PMID: 19001950BACKGROUND
  • Grandner MA, Buxton OM, Jackson N, Sands-Lincoln M, Pandey A, Jean-Louis G. Extreme sleep durations and increased C-reactive protein: effects of sex and ethnoracial group. Sleep. 2013 May 1;36(5):769-779E. doi: 10.5665/sleep.2646.

    PMID: 23633760BACKGROUND
  • Marino M, Li Y, Rueschman MN, Winkelman JW, Ellenbogen JM, Solet JM, Dulin H, Berkman LF, Buxton OM. Measuring sleep: accuracy, sensitivity, and specificity of wrist actigraphy compared to polysomnography. Sleep. 2013 Nov 1;36(11):1747-55. doi: 10.5665/sleep.3142.

    PMID: 24179309BACKGROUND
  • Kossek EE, Hammer LB, Kelly EL, Moen P. Designing Work, Family & Health Organizational Change Initiatives. Organ Dyn. 2014;43(1):53-63. doi: 10.1016/j.orgdyn.2013.10.007.

    PMID: 24683279BACKGROUND
  • Berkman LF, Buxton O, Ertel K, Okechukwu C. Managers' practices related to work-family balance predict employee cardiovascular risk and sleep duration in extended care settings. J Occup Health Psychol. 2010 Jul;15(3):316-29. doi: 10.1037/a0019721.

    PMID: 20604637BACKGROUND
  • Kelly EL, Moen P, Tranby E. Changing Workplaces to Reduce Work-Family Conflict: Schedule Control in a White-Collar Organization. Am Sociol Rev. 2011 Apr;76(2):265-290. doi: 10.1177/0003122411400056.

    PMID: 21580799BACKGROUND
  • Berkman LF, Kelly EL, Hammer LB, Mierzwa F, Bodner T, McNamara T, Koga HK, Lee S, Marino M, Klein LC, McDade TW, Hanson G, Moen P, Buxton OM. Employee Cardiometabolic Risk Following a Cluster-Randomized Workplace Intervention From the Work, Family and Health Network, 2009-2013. Am J Public Health. 2023 Dec;113(12):1322-1331. doi: 10.2105/AJPH.2023.307413.

  • Hurtado DA, Okechukwu CA, Buxton OM, Hammer L, Hanson GC, Moen P, Klein LC, Berkman LF. Effects on cigarette consumption of a work-family supportive organisational intervention: 6-month results from the work, family and health network study. J Epidemiol Community Health. 2016 Dec;70(12):1155-1161. doi: 10.1136/jech-2015-206953. Epub 2016 May 25.

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Lisa F Berkman, PhD

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR
  • Orfeu M Buxton, PhD

    Brigham and Women's Hospital; Harvard Medical School; Harvard School of Public Health; Pennsylvania State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 28, 2014

First Posted

January 30, 2014

Study Start

September 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 15, 2017

Record last verified: 2017-12

Locations