Performance Nutrition for Residents and Fellows

Sleep Deprivation Clinical Trial

Official title:

Performance Nutrition for Residents and Fellows Working Overnight Shifts: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03698123
• Other study ID #: 45690
• Status: Completed
• Phase: N/A
• Start date: October 29, 2018
• Est. completion date: May 11, 2019

Study information

• Verified date: January 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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:

1. 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.

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 11, 2019
• Est. primary completion date: May 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Function
• Diet Habit
• Diet Modification
• Dyssomnias
• Parasomnias
• Physician Well-being
• Shift-Work Related Sleep Disturbance
• Sleep Deprivation

Intervention

Other:
• Dietary Modification
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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	American Medical Association

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. 2021 Nov 9. doi: 10.1097/ACM.0000000000004509. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

Rimmer A. Urgent action is needed to manage doctors' fatigue, says BMA. BMJ. 2018 Jan 9;360:k127. doi: 10.1136/bmj.k127. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference in Work Exhaustion between conditions	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
Primary	Difference in Motor Praxis scores between conditions	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
Primary	Difference in Fractal 2-Back between conditions	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
Primary	Difference in Balloon Analog Risk between conditions	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
Primary	Difference in Psychomotor vigilance test between conditions	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	Difference in Degree of sleepiness between conditions	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

External Links

•   Main manuscript: Performance Nutrition for Physician Trainees Working Overnight Shifts: A Randomized Controlled Trial