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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02946736
Other study ID # W81XWH-16-1-0720
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 21, 2017
Est. completion date December 4, 2020

Study information

Verified date February 2021
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a randomized controlled trial that will assess the effects of (1) the Family-Supportive Supervisor Behavior (FSSB) and Sleep Leadership training and (2) sleep/cognitive effectiveness feedback intervention on health and well-being among full-time employees in the Oregon National Guard, their supervisors, and their families. The interventions involving both health protection and health promotion are expected to contribute to improvements in employees' and their supervisors' sleep, risk behaviors, mental and physical health, and injury, as well as employees' and their spouse/partners' family experiences, health and well-being, and workplace outcomes.


Description:

The overall goal of the Military Employee Sleep and Health (MESH) study is to improve safety, health and well-being of service members in the Oregon National Guard and their families. The MESH Study seeks to do this by training supervisors to support Oregon National Guard service members by focusing on a reduction in work-life stress while increasing sleep health. The Oregon MESH Study proposes that leadership can influence a fundamental change in the recognition of sleep health and service members' overall well-being and the well-being of their family members. With the support of the Oregon National Guard, the MESH Study will provide family-support and sleep leadership training for supervisors while raising awareness of sleep through daily non-invasive sleep measurements. The investigators of the Oregon MESH Study expect positive results for study participants, including reduced stress and increased social support. Longer term, these effects are expected to create a more supportive work environment, which has positive effects on safety, health, well-being, family, and organizational outcomes. The investigators also expect that providing service members with individual sleep feedback will reduce sleep problems and improve sleep awareness.


Recruitment information / eligibility

Status Completed
Enrollment 1284
Est. completion date December 4, 2020
Est. primary completion date May 22, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Full-time employees in the Oregon National Guard, including Military Technicians and Active Guard Reserves. Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
FSSB/Sleep Leadership Training
Supervisors will receive a training addressing family-supportive supervisor behaviors and sleep leadership.
Actigraphy Feedback
Supervisors and employees will receive personalized feedback on their sleep and activity measurements.

Locations

Country Name City State
United States Oregon Health & Science University Portland Oregon

Sponsors (4)

Lead Sponsor Collaborator
Oregon Health and Science University Colorado State University, Portland State University, United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hobfoll, S. E., Vinokur, A. D., Pierce, P. F., & Lewandowski-Romps, L. (2012). The combined stress of family life, work, and war in Air Force men and women: A test of conservation of resources theory. International Journal of Stress Management, 19(3), 217-237.

Matthews RA, Kath LM, Barnes-Farrell JL. A short, valid, predictive measure of work-family conflict: item selection and scale validation. J Occup Health Psychol. 2010 Jan;15(1):75-90. doi: 10.1037/a0017443. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Sleep Quality as assessed by the PROMIS Scale of Sleep-Related Impairment PROMIS: Patient-Reported Outcomes Measurement Information System;
All items will be averaged to compute scale scores.
Change from Baseline Sleep Quality at 4-month post-baseline
Primary Change in Sleep Quality as assessed by the PROMIS Scale of Sleep-Related Impairment PROMIS: Patient-Reported Outcomes Measurement Information System;
All items will be averaged to compute scale scores.
Change from Baseline Sleep Quality at 9-month post-baseline
Primary Change in Sleep Patterns as assessed by objective actigraphic measurements Actigraphic measurements are obtained using Actiwatch2 Change from Baseline Sleep Patterns at 4-month post-baseline
Primary Change in Sleep Patterns as assessed by objective actigraphic measurements Actigraphic measurements are obtained using Actiwatch2 Change from Baseline Sleep Patterns at 9-month post-baseline
Primary Change in Perceived Health as assessed by Hobfoll et al.'s (2012) Perceived Health Scale Change from Baseline Perceived Health at 4-month post-baseline
Primary Change in Perceived Health as assessed by Hobfoll et al.'s (2012) Perceived Health Scale Change from Baseline Perceived Health at 9-month post-baseline
Primary Change in Work-Family Conflict as assessed by Matthews et al.'s (2010) Work-Family Conflict Scale Change from Baseline Work-Family Conflict at 4-month post-baseline
Primary Change in Work-Family Conflict as assessed by Matthews et al.'s (2010) Work-Family Conflict Scale Change from Baseline Work-Family Conflict at 9-month post-baseline
Primary Change in Sleep Quality as assessed by the PROMIS Scale of Sleep Disturbance PROMIS: Patient-Reported Outcomes Measurement Information System;
All items will be averaged to compute scale scores.
Change from Baseline Sleep Quality at 4-month post-baseline
Primary Change in Sleep Quality as assessed by the PROMIS Scale of Sleep Disturbance PROMIS: Patient-Reported Outcomes Measurement Information System;
All items will be averaged to compute scale scores.
Change from Baseline Sleep Quality at 9-month post-baseline
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