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

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.

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

    • California
      • Stanford, California, United States, 94305
        • Stanford University

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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

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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