Performance Nutrition for Residents and Fellows

NCT03698123 | Completed

• 1 other identifier: 45690
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Difference in Degree of sleepiness between conditions

  Two time points (beginning and end of night shifts) on each night for a total of 3 nights

Other Outcomes (1)

• Difference in Work Exhaustion between conditions

  Two time points (beginning and end of night shifts) on each night for a total of 3 nights

Study Arms (1)

Dietary Modification

EXPERIMENTAL

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.

Other: Dietary Modification

Interventions

Dietary Modification OTHER

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.

Dietary Modification

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Food allergies or sensitivities
• Prior anaphylactic reaction to food
• Strict dietary restrictions (e.g. vegan, gluten free)

Sponsors & Collaborators

• Stanford University: lead
• American Medical Association: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (9)

• 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.

  PMID: 29317408 BACKGROUND

• 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.

  PMID: 27215232 BACKGROUND

• 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.

  PMID: 27736177 BACKGROUND

• 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.

  PMID: 27061779 BACKGROUND

• 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.

  PMID: 28740034 BACKGROUND

• 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.

  PMID: 22155490 BACKGROUND

• 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.

  PMID: 28231304 BACKGROUND

• 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.

  PMID: 26216194 BACKGROUND

• 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.

  PMID: 34753859 RESULT

Related Links

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

MeSH Terms

Conditions

Feeding Behavior; Sleep Deprivation; Sleepiness

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Tait D Shanafelt, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Researchers analyze the data will be blinded to the group assignment.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 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

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 5, 2018
• Study Start: October 29, 2018
• Primary Completion: May 11, 2019
• Study Completion: May 11, 2019
• Last Updated: February 15, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)