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.
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
- 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.
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.
- 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
- 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 group | Role | What they receive |
|---|---|---|
| Caregivers | Employees 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.
Cognitive performance
Brief computerized tasks of attention, vigilance, and memory.
Measured: Up to one year
Body Composition
Height, weight, waist circumference, body fat percentage, body mass index
Measured: Up to one year
Diet
Brief computerized survey on fruit, vegetable, and fat intake.
Measured: Up to one year
Work Schedule
Survey on the quantity and distribution of work hours.
Measured: Up to one year
Secondary outcomes (4)
Blood Pressure
Measured: Up to one year
Blood cholesterol, glucose, triglycerides
Fingerstick test
Measured: Up to one year
Breast, skin, and lung cancer prevention behaviors and knowledge
Brief computerized questionnaires.
Measured: Up to one year
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.
- First posted29 Sep 2011 (estimated)
- Study startJan 2012
- Primary completionFeb 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jackilen Shannon, Oregon Health and Science University
- Investigators
- Jackilen Shannon, PhD, Principal investigator, Oregon Health and Science University
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Work Schedule and Sleep Patterns on Caregivers' Health
- ClinicalTrials.gov ID
- NCT01443156
- Acronym / sponsor ID
- OHSU eIRB7542
- Conditions
- Obesity, Diabetes, Cancer, Metabolic Syndrome, Sleep Deprivation
- Keywords
- Diet, Sleep deficiency, Cancer, Obesity, Diabetes, Shift work, Work schedule, Cardiovascular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 29 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregivers | – | –Employees at a local medical facility, including (but not limited to): nurses, laboratory technicians, non-clinical hospital staff |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Declining to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive performance
Time frame: Up to one year
Brief computerized tasks of attention, vigilance, and memory.
Body Composition
Time frame: Up to one year
Height, weight, waist circumference, body fat percentage, body mass index
Diet
Time frame: Up to one year
Brief computerized survey on fruit, vegetable, and fat intake.
Work Schedule
Time frame: Up to one year
Survey on the quantity and distribution of work hours.
4 secondary outcomes
Blood Pressure
Time frame: Up to one year
Blood cholesterol, glucose, triglycerides
Time frame: Up to one year
Breast, skin, and lung cancer prevention behaviors and knowledge
Time frame: Up to one year
Preventive care habits
Time frame: Up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jackilen Shannon, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
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.