- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03698123
Performance Nutrition for Residents and Fellows
January 31, 2022 updated by: Tait Shanafelt, Stanford University
Performance Nutrition for Residents and Fellows Working Overnight Shifts: A Pilot Study
Currently, residents commonly experience dehydration and poor nutrition during nighttime duty hours as a result of heavy work load, lack of time to take nutrition and hydration breaks, or limited or no access to healthy food and drinks which may affect residents' work performance.
The goal of this study is to compare the effects of two different meal compositions with no typical dietary practices (existing conditions) on work performance of the on-call residents during night shifts.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to determine the effects of dietary modifications on resident physicians' work performance during night shifts.
Specific objectives are:
- To assess the effects of macronutrient composition of the test meals on cognitive performance, self-reported sleepiness and fatigue of resident physicians during night-time duty.
- To compare to no intervention, the effects of providing meals before 22:00 hours, and only providing chewing gum, tea, coffee and water onwards to on-call residents, on cognitive performance, self-reported sleepiness and fatigue of resident physicians during night-time duty.
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Stanford, California, United States, 94305
- Stanford University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All residents and fellows performing in hospital overnight work
- Must be able to eat plant source foods (e.g. soy, nuts, seeds) and animal source foods (e.g. meat, eggs, dairy products)
Exclusion Criteria:
- Food allergies or sensitivities
- Prior anaphylactic reaction to food
- Strict dietary restrictions (e.g. vegan, gluten free)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dietary Modification
On the first night of the study, participants can eat and drink as they normally would (no dietary intervention).
On second and third nights participants will be provided meals, snacks and drinks with specific macronutrient composition, encouraged to only eat and drink study meals, snacks and drinks, and to avoid eating after 10:00 hours.
The composition of the study foods and drinks on nights 2 and 3 will be different.
|
Participants will be provided with meals, snacks and drinks with specific macronutrient compositions and encouraged to only eat and drink study meals, snacks and drinks and to avoid eating after 10:00 hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Motor Praxis scores between conditions
Time Frame: Two time points (beginning and end of night shifts) on each night for a total of 3 nights
|
Motor Praxis is a validated neurocognitive test that assesses sensory-motor speed.
This test takes approximately 30 seconds to complete and will be measured at two time points (beginning and end of each night shift) in each of the 3 conditions .
Differences in accuracy (percentage of correct responses, a higher percentage is better), duration (in milliseconds, lower duration is better), reaction time (in milliseconds, lower reaction time is better) and composite scores (0-1000, higher score is better) will be reported and compared.
|
Two time points (beginning and end of night shifts) on each night for a total of 3 nights
|
Difference in Fractal 2-Back between conditions
Time Frame: Two time points (beginning and end of night shifts) on each night for a total of 3 nights
|
Fractal 2-Back is a validated neurocognitive test that assess working memory.
This test takes approximately 2 minutes to complete and will be measured at two time points (beginning and end of each night shift) in each of the 3 conditions.
Differences in reaction time (in milliseconds, lower reaction time is better) , accuracy (percentage of correct responses, a higher percentage is better) and composite scores (0-1000, higher score is better) will be reported and compared.
|
Two time points (beginning and end of night shifts) on each night for a total of 3 nights
|
Difference in Balloon Analog Risk between conditions
Time Frame: Two time points (beginning and end of night shifts) on each night for a total of 3 nights
|
Balloon Analog Risk is a validated neurocognitive test that assess risk decision making.
This test takes approximately 2 minutes to complete and will be measured at two time points (beginning and end of each night shift) in each of the 3 conditions.
Differences in risk propensity (higher scores indicative of greater risk-taking propensity), duration (in milliseconds, lower reaction time is better) and composite scores (0-1000, higher score is better) will be reported and compared.
|
Two time points (beginning and end of night shifts) on each night for a total of 3 nights
|
Difference in Psychomotor vigilance test between conditions
Time Frame: Two time points (beginning and end of night shifts) on each night for a total of 3 nights
|
Psychomotor vigilance test is a validated neurocognitive test that assess vigilant attention.
This test takes approximately 3 minutes to complete will be measured at two time points (beginning and end of each night shift) in each of the 3 conditions.
Differences in reaction time (in milliseconds, lower reaction time is better), lapses (number, less is better) and composite scores measured (0-1000, higher score is better) will be reported and compared.
|
Two time points (beginning and end of night shifts) on each night for a total of 3 nights
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Degree of sleepiness between conditions
Time Frame: Two time points (beginning and end of night shifts) on each night for a total of 3 nights
|
Will use validated Stanford Sleepiness Scale (SSS) developed by William C. Dement, M.D., Ph.D. SSS a self-rating scale used to quantify progressive steps in sleepiness at a certain point in time.
It is a seven-point Likert-type scale ranging from "feeling active, vital alert, or wide awake" (score = 1) to "no longer fighting sleep, sleep onset soon and having dream-like thoughts" (score = 7).
Selected scores by the participants will be reported each time.
This test takes approximately 15 seconds to complete.
Differences in degree of sleepiness measured at two time points (beginning and end of each night shift) in each of the 3 conditions will be reported and compared.
|
Two time points (beginning and end of night shifts) on each night for a total of 3 nights
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Work Exhaustion between conditions
Time Frame: Two time points (beginning and end of night shifts) on each night for a total of 3 nights
|
Work Exhaustion scale, developed and modified by Mickey Trockel MD, PhD, to explore the degree of work related fatigue in residents and fellows.
It has 4 questions with a 5 point Likert scale ranging from not at all to extremely.
This test takes approximately 30 second to complete.
The total score is the average scores of the 4 items and falls between 0 and 4. Scores equal to higher than 1.33 indicate work-related fatigue.
Differences in Work Exhaustion scores measured at two time points (beginning and end of each night shift) in each of the 3 conditions will be reported and compared.
|
Two time points (beginning and end of night shifts) on each night for a total of 3 nights
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Tait D Shanafelt, MD, Stanford University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rimmer A. Urgent action is needed to manage doctors' fatigue, says BMA. BMJ. 2018 Jan 9;360:k127. doi: 10.1136/bmj.k127. No abstract available.
- Hamidi MS, Boggild MK, Cheung AM. Running on empty: a review of nutrition and physicians' well-being. Postgrad Med J. 2016 Aug;92(1090):478-81. doi: 10.1136/postgradmedj-2016-134131. Epub 2016 May 23.
- Gupta CC, Dorrian J, Grant CL, Pajcin M, Coates AM, Kennaway DJ, Wittert GA, Heilbronn LK, Della Vedova CB, Banks S. It's not just what you eat but when: The impact of eating a meal during simulated shift work on driving performance. Chronobiol Int. 2017;34(1):66-77. doi: 10.1080/07420528.2016.1237520. Epub 2016 Oct 13.
- Paech GM, Banks S, Pajcin M, Grant C, Johnson K, Kamimori GH, Vedova CB. Caffeine administration at night during extended wakefulness effectively mitigates performance impairment but not subjective assessments of fatigue and sleepiness. Pharmacol Biochem Behav. 2016 Jun;145:27-32. doi: 10.1016/j.pbb.2016.03.011. Epub 2016 Apr 7.
- Grant CL, Dorrian J, Coates AM, Pajcin M, Kennaway DJ, Wittert GA, Heilbronn LK, Vedova CD, Gupta CC, Banks S. The impact of meal timing on performance, sleepiness, gastric upset, and hunger during simulated night shift. Ind Health. 2017 Oct 7;55(5):423-436. doi: 10.2486/indhealth.2017-0047. Epub 2017 Jul 25.
- Reyner LA, Wells SJ, Mortlock V, Horne JA. 'Post-lunch' sleepiness during prolonged, monotonous driving - effects of meal size. Physiol Behav. 2012 Feb 28;105(4):1088-91. doi: 10.1016/j.physbeh.2011.11.025. Epub 2011 Dec 6.
- Attuquayefio T, Stevenson RJ, Oaten MJ, Francis HM. A four-day Western-style dietary intervention causes reductions in hippocampal-dependent learning and memory and interoceptive sensitivity. PLoS One. 2017 Feb 23;12(2):e0172645. doi: 10.1371/journal.pone.0172645. eCollection 2017.
- El-Sharkawy AM, Bragg D, Watson P, Neal K, Sahota O, Maughan RJ, Lobo DN. Hydration amongst nurses and doctors on-call (the HANDS on prospective cohort study). Clin Nutr. 2016 Aug;35(4):935-42. doi: 10.1016/j.clnu.2015.07.007. Epub 2015 Jul 16.
- Makowski MS, Trockel MT, Menon NK, Wang H, Katznelson L, Shanafelt TD. Performance Nutrition for Physician Trainees Working Overnight Shifts: A Randomized Controlled Trial. Acad Med. 2022 Mar 1;97(3):426-435. doi: 10.1097/ACM.0000000000004509.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 29, 2018
Primary Completion (Actual)
May 11, 2019
Study Completion (Actual)
May 11, 2019
Study Registration Dates
First Submitted
September 25, 2018
First Submitted That Met QC Criteria
October 3, 2018
First Posted (Actual)
October 5, 2018
Study Record Updates
Last Update Posted (Actual)
February 15, 2022
Last Update Submitted That Met QC Criteria
January 31, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 45690
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
This data is strictly confidential and to protect the privacy of our study participants we will not be sharing the results.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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