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Well-BeingMESHNCT02946736

Oregon Military Employee Sleep and Health Study

A study testing FSSB/Sleep Leadership Training and Actigraphy Feedback in people with Well-Being and Sleep, run by Oregon Health and Science University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a randomized controlled trial that assesses 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Well-Being, Sleep, Health Behavior
What is being tested?
FSSB/Sleep Leadership Training and Actigraphy Feedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
704 participants
Where
1 siteUnited States
Study dates
21 Jul 2017to 4 Dec 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Full-time employees in the Oregon National Guard, including Military Technicians and Active Guard Reserves.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Oregon Health & Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Evaluation of a Work-Family and Sleep Leadership Intervention in the Oregon National Guard: A Behavioral Health Leadership Approach

This study is a randomized controlled trial that assesses 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.

Read the detailed 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.

Being tested
FSSB/Sleep Leadership Training, Actigraphy Feedback
Keywords
Sleep, Physical Health, Psychological Health, Well-Being, Employee, Actigraphy
Medical subject headings
Health Behavior, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FSSB/Sleep Leadership TrainingBehavioural

    Supervisors will receive a training addressing family-supportive supervisor behaviors and sleep leadership.

  • Actigraphy FeedbackBehavioural

    Supervisors and employees will receive personalized feedback on their sleep and activity measurements.

Study groups in NCT02946736
Study groupRoleWhat they receive
Supervisor InterventionExperimentalSupervisors in the intervention group will go through the FSSB/sleep leadership training and receive actigraphy feedback.
Receives: Behavioral: FSSB/Sleep Leadership Training; Behavioral: Actigraphy Feedback
Employee InterventionExperimentalEmployees in the intervention group will receive actigraphy feedback.
Receives: Behavioral: Actigraphy Feedback
Waitlist ControlNo interventionSupervisor training and actigraphy feedback provided AFTER final 9 month data collection.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-Reported Sleep Duration

    Total number of hours calculated from reported bed time and wake time. Minimum 0 hours, Maximum 24 hours. Longer duration indicates longer sleep duration. Ideal range is 7-9 hours of sleep per night.

    Measured: 4 months

  2. Self-Reported Sleep Duration

    Total number of hours calculated from reported bed time and wake time. Minimum 0 hours, Maximum 24 hours. Longer duration indicates longer sleep duration. Ideal range is 7-9 hours of sleep per night.

    Measured: 9 months

  3. Patient Reported Outcomes Measurement Information System (PROMIS): Sleep Disturbance Insomnia Subscale

    Four item subscale of the larger 8 item Sleep Disturbance scale. Likert-type responses: 1 = Not at all to 5 = Very much).

    T-Scores were created using HealthMeasures Scoring service, where data are uploaded into the HealthMeasures scoring service website, which generates T-Scores. This is considered the most accurate option.

    T-Scores estimates were developed using a population of 2,252 participants, 259 of which had clinical sleep disorders, and was intended to be representative of the US population. This is the reference population that the T-score means and SDs were calibrated and centered with.

    The T-Scores that HealthMeasures generates are not precisely at a mean of 50 and standard deviation of 10 because they are based on the unique MESH samples. A higher PROMIS T-score represents more of the concept being measured (worse).

    Measured: 4 months

  4. Patient Reported Outcomes Measurement Information System (PROMIS): Sleep Disturbance Insomnia Subscale

    Four item subscale of the larger 8 item Sleep Disturbance scale. Likert-type responses: 1 = Not at all to 5 = Very much). T-Scores were created using HealthMeasures Scoring service, where data are uploaded into the HealthMeasures scoring service website, which generates T-Scores. This is considered the most accurate option.

    T-Scores estimates were developed using a population of 2,252 participants, 259 of which had clinical sleep disorders, and was intended to be representative of the US population. This is the reference population that the T-score means and SDs were calibrated and centered with.

    The T-Scores that HealthMeasures generates are not precisely at a mean of 50 and standard deviation of 10 because they are based on the unique MESH samples. A higher PROMIS T-score represents more of the concept being measured.

    Measured: 9 months

  5. Patient Reported Outcomes Measurement Information System (PROMIS): Dissatisfaction With Sleep Subscale

    Four item subscale of the larger 8 item Sleep Disturbance scale. Likert-type responses: 1 = Not at all to 5 = Very much.

    T-Scores were created using HealthMeasures Scoring service, where data are uploaded into the HealthMeasures scoring service website, which generates T-Scores. This is considered the most accurate option.

    T-Scores estimates were developed using a population of 2,252 participants, 259 of which had clinical sleep disorders, and was intended to be representative of the US population. This is the reference population that the T-score means and SDs were calibrated and centered with.

    The T-Scores that HealthMeasures generates are not precisely at a mean of 50 and standard deviation of 10 because they are based on the unique MESH samples. A higher PROMIS T-score represents more of the concept being measured (worse).

    Measured: 4 months

  6. Patient Reported Outcomes Measurement Information System (PROMIS): Dissatisfaction With Sleep Subscale

    Four item subscale of the larger 8 item Sleep Disturbance scale. Likert-type responses: 1 = Not at all to 5 = Very much).

    T-Scores were created using HealthMeasures Scoring service, where data are uploaded into the HealthMeasures scoring service website, which generates T-Scores. This is considered the most accurate option.

    T-Scores estimates for Dissatisfaction with Sleep were developed using a population of 2,252 participants, 259 of which had clinical sleep disorders, and was intended to be representative of the US population. This is the reference population that the T-score means and SDs were calibrated and centered with.

    The T-Scores that HealthMeasures generates are not precisely at a mean of 50 and standard deviation of 10 because they are based on the unique MESH samples. A higher PROMIS T-score represents more of the concept being measured (worse).

    Measured: 9 months

  7. Patient Reported Outcomes Measurement Information System (PROMIS): Sleep Related Impairment Subscale (SRI)

    8 item scale. Likert-type responses: 1 = Not at all to 5 = Very much). T-Scores were created using HealthMeasures Scoring service, where data are uploaded into the HealthMeasures scoring service website, which generates T-Scores. This is considered the most accurate option.

    T-Scores estimates for SRI were developed using a population of 2,252 participants, 259 of which had clinical sleep disorders, and was intended to be representative of the US population. This is the reference population that the T-score means and SDs were calibrated and centered with.

    The T-Scores that HealthMeasures generates are not precisely at a mean of 50 and standard deviation of 10 because they are based on the unique MESH samples. A higher PROMIS T-score represents more sleep impairment (worse).

    Measured: 4 months

  8. Patient Reported Outcomes Measurement Information System (PROMIS): Sleep Related Impairment Subscale (SRI)

    8 item scale. Likert-type responses: 1 = Not at all to 5 = Very much). T-Scores were created using HealthMeasures Scoring service, where data are uploaded into the HealthMeasures scoring service website, which generates T-Scores. This is considered the most accurate option.

    T-Scores estimates for SRI were developed using a population of 2,252 participants, 259 of which had clinical sleep disorders, and was intended to be representative of the US population. This is the reference population that the T-score means and SDs were calibrated and centered with.

    The T-Scores that HealthMeasures generates are not precisely at a mean of 50 and standard deviation of 10 because they are based on the unique MESH samples. A higher PROMIS T-score represents more sleep impairment (worse).

    Measured: 9 months

  9. Actigraphic Sleep Duration: Total Sleep Time (TST)

    Actigraphic measurements obtained using Actiwatch2 worn for 3 weeks Average sleep duration in hours Great duration generally better, with target range of 7-9 hours each sleep period.

    Measured: 9 months

  10. Actigraphic Sleep Efficiency: Wake After Sleep Onset (WASO)

    Actigraphic measurements obtained using Actiwatch2 worn for 3 weeks Average number of minutes spent awake during the sleep period. More minutes indicates worse outcome.

    Measured: 9-months

  11. Overall Job Satisfaction Scale

    Service member satisfaction with current job; Likert-type scale 1 = Strongly disagree to 5 = Strongly agree, mean created from the 3 items.

    Scores could range from 0-5 with higher levels indicating greater satisfaction. Source: Cammann et al., 1983

    Measured: 9-months

  12. Turnover Intentions

    Service member intention to quit current job; Two items with responses on Likert-type scale 1 = Strongly disagree to 5 = Strongly agree.

    Overall score created with a mean of the two items, with higher levels indicating greater intention to leave one's job.

    Source: Boroff \& Lewin, 1997

    Measured: 9-months

  13. Perceived Stress Scale

    Service member self-reported stress; Likert-type scale 0 = Never to 4 = Very often, combined to a mean score, with a possible range from 0 to 4.

    Higher scores indicate greater stress (worse). Source: Cohen \& Williamson, 1988

    Measured: 9-months

  14. Walter Reed Functional Impairment: Occupational Subscale (OFI)

    Service member difficulty with completing work tasks and quality; 6 items with Likert-type responses: 1 = No difficulty at all to 5 = Extreme difficulty, mean score created from all items, with possible score range from 1 to 5.

    Higher levels indicating greater impairment (worse). Source: Subscale of Overall Functional Impairment by Herrell et al., 2014

    Measured: 9-months

  15. Walter Reed Functional Impairment Scale: Personal Functioning Subscale (PFI)

    Service member difficulty with getting personal life skills completed; 2 items with Likert-type responses: 1 = No difficulty at all to 5 = Extreme difficulty, mean score created from all items, with possible score range from 1 to 5.

    Higher levels indicating greater impairment (worse). Source: Subscale of Overall Functional Impairment by Herrell et al., 2014

    Measured: 9-months

  16. Walter Reed Functional Impairment Scale: Social Functional Impairment Subscale (SFI)

    Service member difficulty functioning in social situations; 4 items with Likert-type responses: 1 = No difficulty at all to 5 = Extreme difficulty, mean score created from all items, with possible score range from 1 to 5.

    Higher levels indicating greater impairment (worse). Source: Subscale of Overall Functional Impairment by Herrell et al., 2014

    Measured: 9-months

Secondary outcomes (2)
  1. Family Supportive Supervisor Behaviors (FSSB)

    Perceived supervisor support for work-family integration as reported by service member, 4 items, with responses on Likert-type scale 1=Strongly disagree to 5= Strongly agree, overall score created by mean score, with possible scores ranging from 1 to 5..

    Higher scores indicating higher levels of support (better) Source: Hammer et al., 2013

    Measured: 4-months

  2. Sleep Leadership

    Perceived supervisor support for sleep health as reported by service member, 8 items, with responses on Likert-type scale 1=Never to 5= Always, overall score created by mean score, with possible scores ranging from 1 to 5..

    Higher scores indicating higher levels of support (better) Source: Modified version of Gunia et al., 2015

    Measured: 4-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2016 (estimated)
  2. Study start21 Jul 2017
  3. Primary completion22 May 2020
  4. Study completion4 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
704 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02946736
Sponsor's protocol ID
W81XWH-16-1-0720
Acronym
MESH
Status last verified
Nov 2024
First submitted
19 Oct 2016
Last updated
3 Jan 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing FSSB/Sleep Leadership Training and Actigraphy Feedback in people with Well-Being and Sleep, run by Oregon Health and Science University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-Reported Sleep Duration (time frame: 4 months). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02946736, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.

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