Shift Work Type Circadian Rhythm Sleep DisorderNCT02522195
Meal Distribution Across the Day in Female Nurses Working Shifts
An observational study of Shift Work Type Circadian Rhythm Sleep Disorder and Imbalance of Constituents of Food Intake, run by Federal University of Uberlandia.
Trial summary
This study assessed the meal distribution across the day (energy and macronutrient intake) and its relationship to the nutritional status of nursing professionals. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Shift Work Type Circadian Rhythm Sleep Disorder, Imbalance of Constituents of Food Intake
- How many people
- 221 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Jan 2013
- 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 19 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Woman who were part of Nursing Staff of University Hospital, and agreed to participate in the study. Each volunteer provided a full, written informed consent.
Who may be able to join
- Eligible participants were regularly employed by the hospital, with 36-hours per week scheduke, not counting additional shifts and overtime work.
Who cannot join
- Volunteers who did not supply the necessary information for the development of the research and who were pregnant or lactating.
About this study
Official title: Meal Distribution Across the Day in Female Nurses Working Shifts and Their Relationship With Nutritional Status
This study assessed the meal distribution across the day (energy and macronutrient intake) and its relationship to the nutritional status of nursing professionals.
Read the detailed description
221 female nursing professionals from Brazilian University hospital were classified in three shifts: day shift (n=112), night shift (n=55), and day-night shift (n=54).
Food intake assessment (3-day 24-hour recall); Anthropometric variables (weight, height, waist circumference and hip circumference); Sleep time on working days and day off.
- Keywords
- shift work, nutritional status, nursing professionals, meal distribution, food intake
What is being measured
The primary outcome is the main question the study is designed to answer.
meal distribution
3-Day 24-Hour Recall Questionnaire.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startNov 2011
- Primary completionNov 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift Work Type Circadian Rhythm Sleep DisorderStudies of the same condition, open and under way.
- 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martina Pafume Coelho, Federal University of Uberlandia
- Investigators
- Cibele Crispim, PhD, Principal investigator, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522195
- Sponsor's protocol ID
- FUUberlandia
- Status last verified
- Aug 2015
- First submitted
- 5 Aug 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meal Distribution Across the Day in Female Nurses Working Shifts and Their Relationship With Nutritional Status
- ClinicalTrials.gov ID
- NCT02522195
- Acronym / sponsor ID
- FUUberlandia
- Keywords
- shift work, nutritional status, nursing professionals, meal distribution, food intake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 13 Aug 2015 (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.
This study assessed the meal distribution across the day (energy and macronutrient intake) and its relationship to the nutritional status of nursing professionals.
Detailed description
221 female nursing professionals from Brazilian University hospital were classified in three shifts: day shift (n=112), night shift (n=55), and day-night shift (n=54).
Food intake assessment (3-day 24-hour recall); Anthropometric variables (weight, height, waist circumference and hip circumference); Sleep time on working days and day off.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Woman who were part of Nursing Staff of University Hospital, and agreed to participate in the study. Each volunteer provided a full, written informed consent.
Key inclusion criteria (1 listed)
- Eligible participants were regularly employed by the hospital, with 36-hours per week scheduke, not counting additional shifts and overtime work.
Key exclusion criteria (1 listed)
- Volunteers who did not supply the necessary information for the development of the research and who were pregnant or lactating.
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
meal distribution
Time frame: 1 year
3-Day 24-Hour Recall Questionnaire.
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 13 Aug 2015.
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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.
Cibele Crispim, PhD principal investigator
Federal University of Uberlandia
Questions about this trial
What is this clinical trial studying?
An observational study of Shift Work Type Circadian Rhythm Sleep Disorder and Imbalance of Constituents of Food Intake, run by Federal University of Uberlandia.
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 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
meal distribution (time frame: 1 year). 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 13 Aug 2015.