Clinical trial NCT03698123: Performance Nutrition for Residents and Fellows
Official title: Performance Nutrition for Residents and Fellows Working Overnight Shifts: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physician Well-being
Cognitive Function
Diet Modification
Diet Habit
Shift-Work Related Sleep Disturbance
Sleep Deprivation
Keywords: Nutrition
Physician well-being
Cognitive performance
Sleepiness
Shift-work
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: American Medical Association
First posted: 2018-10-05
Enrollment: 61
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study participants will participate in the study 3 nights with one control night and two dietary interventions nights.The order of the 2 dietary intervention groups will be randomized per block.

There are two possible combinations and the order will be randomized using a computer-generated random-number sequence. There will be at least a 24-hour wash-out period between study nights to minimize the carry-over effects of the cross-over design as well as learning effects of the computerized cognitive tests.

A: Control- no intervention, B: intervention 1 arm, C: Intervention 2 The order of the blocks will be randomized. block a: A, B, C block b: A, C, B
Primary purpose: OTHER

Brief 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.

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:

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Difference in Motor Praxis scores between conditions
timeFrame: Two time points (beginning and end of night shifts) on each night for a total of 3 nights
measure: Difference in Fractal 2-Back between conditions
timeFrame: Two time points (beginning and end of night shifts) on each night for a total of 3 nights
measure: Difference in Balloon Analog Risk between conditions
timeFrame: Two time points (beginning and end of night shifts) on each night for a total of 3 nights
measure: Difference in Psychomotor vigilance test between conditions
timeFrame: Two time points (beginning and end of night shifts) on each night for a total of 3 nights
Secondary outcomes:
measure: Difference in Degree of sleepiness between conditions
timeFrame: Two time points (beginning and end of night shifts) on each night for a total of 3 nights
Other outcomes:
measure: Difference in Work Exhaustion between conditions
timeFrame: Two time points (beginning and end of night shifts) on each night for a total of 3 nights
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Tait D Shanafelt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.
citation: 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.
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.
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. 2022 Mar 1;97(3):426-435. doi: 10.1097/ACM.0000000000004509.