Clinical trial NCT01443156: The Effects of Work Schedule and Sleep Patterns on Caregivers' Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Diabetes
Cancer
Metabolic Syndrome
Sleep Deprivation
Keywords: Diet
Sleep deficiency
Cancer
Obesity
Diabetes
Shift work
Work schedule
Cardiovascular disease
Body composition
Body mass index
Body fat percentage
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2011-09-29
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.)

Brief 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. 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:

* 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Declining to consent

Primary outcomes:
measure: Cognitive performance
timeFrame: Up to one year
measure: Body Composition
timeFrame: Up to one year
measure: Diet
timeFrame: Up to one year
measure: Work Schedule
timeFrame: Up to one year
Secondary outcomes:
measure: Blood Pressure
timeFrame: Up to one year
measure: Blood cholesterol, glucose, triglycerides
timeFrame: Up to one year
measure: Breast, skin, and lung cancer prevention behaviors and knowledge
timeFrame: Up to one year
measure: Preventive care habits
timeFrame: Up to one year
Other outcomes:
Locations:
city: Bend
country: United States
facility: St. Charles Medical Center
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Jackilen Shannon, PhD
role: PRINCIPAL_INVESTIGATOR
References: