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ObesityNCT01443156

The Effects of Work Schedule and Sleep Patterns on Caregivers' Health

An observational study of Obesity and Diabetes, 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

BACKGROUND. Sleep deficiency (not getting enough sleep) is widespread in American adults and can lead to many harmful health outcomes such as a higher risk of obesity, heart disease, and diabetes. Sleep deficiency can also harm cognitive performance, which refers to one's awareness and thinking ability. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity, Diabetes, Cancer
How many people
211 participants
Where
1 siteUnited States
Study dates
Jan 2012to Jan 2014
Phase
Observational
Are there results?
None posted in the registry

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

Study population: Cohort participants will be recruited from employees at a local health care center. Job categories may include, but are not limited to: * Administrative services * Clinical services (radiology, laboratory, pharmacy, etc.) * Clinical support services (aide, clerk, processing, records, etc.) * Practitioner (physician, physician assistant, nurse practitioner, etc.) * Non-clinical services (food, nutrition, housekeeping, etc.) * Nursing services-registered nurse * Nursing services-certified nursing assistant * Rehabilitative services (occupational therapy, speech therapy, physical therapy, etc.)

Who may be able to join

  • Employed caregiver in a hospital setting
  • 18 years of age or older
  • Completion of minimal set of stations (see below, section III.d.)
  • Consent given electronically

Who cannot join

  • Declining to consent

Trial locations and contacts

1 site in 1 country.

United States1 site
  • St. Charles Medical Center

    Bend, Oregon, 97701

Other trials in United States

About this study

BACKGROUND. Sleep deficiency (not getting enough sleep) is widespread in American adults and can lead to many harmful health outcomes such as a higher risk of obesity, heart disease, and diabetes. Sleep deficiency can also harm cognitive performance, which refers to one's awareness and thinking ability. Sleep deficiency and sleep-related health issues are of high interest among those who have irregular and/or extended work schedules, because such schedules can interfere with normal biological rhythms of sleepiness and wakefulness.

PURPOSE. This study will examine the health and cognitive effects of work schedule and sleep patterns in caregivers (such as nurses, laboratory technicians, and non-clinical hospital staff). The investigators hypothesize that the nontraditional, irregular, and extended work hours common in these professions will have adverse health and cognitive effects. The purposes of this protocol are to:

Read more
  • Enroll caregivers into a one year cohort study on the relationships among work schedule, sleep, diet, chronic disease, and cognitive performance. (A cohort study follows a group of participants over time to see how different behaviors or risk factors affect health.)
  • Collect data from caregivers on work schedule, sleep, diet, chronic disease, and cognitive performance.
  • Give personalized information and feedback to caregivers about these health factors.
  • Educate caregivers about healthy diet and exercise choices.
  • Collect saliva from caregivers for future research on the role of genes in health. (Specimen collection for genetic testing will be offered as a separate option for study participants.) RECRUITMENT. This study will use the Let's Get Healthy! health research and education program (OHSU IRB #3694) as a platform for recruitment and data collection. Caregivers will be invited to participate in a Let's Get Healthy! event and will be given information prior to the event about the cohort study. At the Let's Get Healthy! event, caregivers will first consent to the anonymous research study (OHSU IRB #3694), in which demographic and health screening data are linked to a random number. Caregivers will then have the option to consent to a cohort study, in which data are no longer anonymous but instead linked to participants' names and contact information.

PROCEDURES. This cohort study piggybacks on procedures already approved for the Let's Get Healthy! program (OHSU IRB #3694). Let's Get Healthy! is a study in which participants provide anonymous data at health fairs through any or all of the following manners: short computer surveys on cancer awareness, risk factors, and family history (with immediate feedback given on cancer risk and prevention); short computer surveys on diet and sleep patterns (with immediate printed feedback given); health screening measurements (blood pressure, height, weight, waist circumference, body mass index, body fat percentage); a finger stick to assess sugar and fat levels in blood; and a mouthwash swish to provide a saliva specimen.

However, this cohort study (OHSU IRB #7542) will make the following changes and additions:

  • Personal health data, instead of being anonymous, will be linked to participants' names and contact information (for follow-up data collection).
  • Let's Get Healthy! events will include cognitive performance tests, a preventative-care survey, and a work schedule survey.
  • Participants will provide data not only at an initial Let's Get Healthy! event, but also at a follow-up event and during the time period between events. Between events, participants will do the surveys on work schedule, diet, and sleep, and they will complete cognitive performance tests.
  • There will be a separate consent process for participants to provide a fully identifiable saliva specimen.

DATA ANALYSIS. Participants' health data will be fully identifiable at the time of data collection but will be coded and stored in a physically separate location from the identifiable information. The link between identifiable information and coded health information will be stored on a password protected computer, and all identifiable information will be deleted upon completion of data analyses. Data will be analyzed to explore relationships among work schedule, sleep, diet, body composition, metabolic health, chronic disease, and cognitive performance in caregivers. Genetic relationships with these factors will be analyzed in those who provided a saliva specimen during entry visit data collection.

Keywords
Diet, Sleep deficiency, Cancer, Obesity, Diabetes, Shift work, Work schedule, Cardiovascular disease, Body composition, Body mass index, Body fat percentage
Medical subject headings
Obesity, Diabetes Mellitus, Neoplasms, Metabolic Syndrome, Sleep Deprivation, Cardiovascular Diseases

What participants receive

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

Study groups in NCT01443156
Study groupRoleWhat they receive
CaregiversEmployees at a local medical facility, including (but not limited to): nurses, laboratory technicians, non-clinical hospital staff

What is being measured

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

  1. Cognitive performance

    Brief computerized tasks of attention, vigilance, and memory.

    Measured: Up to one year

  2. Body Composition

    Height, weight, waist circumference, body fat percentage, body mass index

    Measured: Up to one year

  3. Diet

    Brief computerized survey on fruit, vegetable, and fat intake.

    Measured: Up to one year

  4. Work Schedule

    Survey on the quantity and distribution of work hours.

    Measured: Up to one year

Secondary outcomes (4)
  1. Blood Pressure

    Measured: Up to one year

  2. Blood cholesterol, glucose, triglycerides

    Fingerstick test

    Measured: Up to one year

  3. Breast, skin, and lung cancer prevention behaviors and knowledge

    Brief computerized questionnaires.

    Measured: Up to one year

  4. Preventive care habits

    Brief survey on basic health behaviors and use of preventive care resources.

    Measured: Up to one year

Timeline

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

  1. First posted29 Sep 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionFeb 2013
  4. Study completionJan 2014

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01443156
Sponsor's protocol ID
OHSU eIRB7542
Status last verified
Oct 2023
First submitted
20 Sep 2011
Last updated
2 Nov 2023
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Diabetes, 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 4 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 2 Nov 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Cognitive performance (time frame: Up to one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Nov 2023.

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