Eating Behaviors in Shift Workers

March 22, 2024 updated by: Marie-Pierre St-Onge, Columbia University

The Interaction of Shift Work and Food Environment on Eating Behaviors and Appetite

This study will compare eating behaviors and measures of hunger and fullness between day and night workers in order to better understand why night workers are at increased risk for obesity and related diseases.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

100

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 Contact

Study Contact Backup

Study Locations

    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Contact:

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

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Work ~ 8-hour shifts during day or night on 3 or more consecutive days of the week
  • BMI 19-35 kg/m^2
  • Age 20-55 years of age
  • Metabolically healthy
  • Weight stable over previous 3 months
  • Lives in New York City area

Exclusion Criteria:

  • Pregnant or less than 1 year postpartum at time of study
  • Smoking
  • History of drug or alcohol abuse
  • Rotating shift work
  • Habitual sleep duration of more than 6 hour per night
  • Obstructive sleep apnea
  • Transmeridian travel
  • Type 2 diabetes
  • Cardiovascular disease
  • Hypertension
  • Participation in diet or weight loss program in the 3 months prior to enrollment
  • Psychiatric or sleep disorder
  • Food allergies or intolerances
  • Dislike of or unwillingness to eat test foods

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Day worker
Men and women who work only day shift for at least 3 consecutive days of the week
The amount of food served (g) at the first two meals of each day. These amounts will vary across 4 weeks.
Active Comparator: Night worker
Men and women who work only night shift for at least 3 consecutive days of the week
The amount of food served (g) at the first two meals of each day. These amounts will vary across 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food intake
Time Frame: 24-hours intake period
Food by weight (g) in response to variations in portion served
24-hours intake period
Energy intake
Time Frame: 24-hours intake period
Food by energy (kcal) in response to variations in portion served
24-hours intake period
Energy density consumed
Time Frame: 24-hours intake period
Energy density consumed (kcal/g) in response to variations in portion served
24-hours intake period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appetite-regulating hormones
Time Frame: 2-hours measurement period
Appetite-regulating hormones, including Glucagon-like-peptide 1 (GLP-1) and ghrelin will be analyzed from plasma from whole blood samples collected while fasted and at 30, 60, 90, and 120 min postprandial. Area under the curve of plasma concentrations will be calculated for each individual appetite-regulating hormone
2-hours measurement period
Hunger and fullness
Time Frame: 24-hours measurement period
Subjective measures related to hunger, fullness, and prospective consumption will be measured before and after meals via visual analog scales. The range of scores are 0 mm to 100 mm, with higher scores indicating greater feelings of the corresponding measure (e.g. greater hunger). Post-meal measures, adjusted for the corresponding pre-meal measure, will be analyzed as individual outcomes. Area under the curve will also be calculated for each measure.
24-hours measurement period

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Faris M Zuraikat, PhD, Columbia University
  • Principal Investigator: Marie-Pierre St-Onge, PhD, Columbia University

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)

December 14, 2020

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

June 30, 2020

First Submitted That Met QC Criteria

July 10, 2020

First Posted (Actual)

July 13, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) will be shared with other researchers upon request.

IPD Sharing Time Frame

After the study is completed (data collection, analysis, publication) and after any subsequent funding applications have been submitted.

IPD Sharing Access Criteria

Upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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