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Eating Behaviors in Shift Workers

Primary Purpose

Shift Work Type Circadian Rhythm Sleep Disorder, Eating Behavior

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Portion size
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shift Work Type Circadian Rhythm Sleep Disorder

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Columbia University Irving Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Day worker

Night worker

Arm Description

Men and women who work only day shift for at least 3 consecutive days of the week

Men and women who work only night shift for at least 3 consecutive days of the week

Outcomes

Primary Outcome Measures

Food intake
Food by weight (g) in response to variations in portion served
Energy intake
Food by energy (kcal) in response to variations in portion served
Energy density consumed
Energy density consumed (kcal/g) in response to variations in portion served

Secondary Outcome Measures

Appetite-regulating hormones
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
Hunger and fullness
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.

Full Information

First Posted
June 30, 2020
Last Updated
February 6, 2023
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT04468672
Brief Title
Eating Behaviors in Shift Workers
Official Title
The Interaction of Shift Work and Food Environment on Eating Behaviors and Appetite
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shift Work Type Circadian Rhythm Sleep Disorder, Eating Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a mixed design with two participant groups (between-subject), day and night workers, each being exposed to 4 levels of food portion size (within-subjects factor)
Masking
Outcomes Assessor
Masking Description
Statistician will be blinded to participant group and condition.
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Day worker
Arm Type
Active Comparator
Arm Description
Men and women who work only day shift for at least 3 consecutive days of the week
Arm Title
Night worker
Arm Type
Active Comparator
Arm Description
Men and women who work only night shift for at least 3 consecutive days of the week
Intervention Type
Behavioral
Intervention Name(s)
Portion size
Intervention Description
The amount of food served (g) at the first two meals of each day. These amounts will vary across 4 weeks.
Primary Outcome Measure Information:
Title
Food intake
Description
Food by weight (g) in response to variations in portion served
Time Frame
24-hours intake period
Title
Energy intake
Description
Food by energy (kcal) in response to variations in portion served
Time Frame
24-hours intake period
Title
Energy density consumed
Description
Energy density consumed (kcal/g) in response to variations in portion served
Time Frame
24-hours intake period
Secondary Outcome Measure Information:
Title
Appetite-regulating hormones
Description
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
Time Frame
2-hours measurement period
Title
Hunger and fullness
Description
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.
Time Frame
24-hours measurement period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehreen Bhatti, BS
Phone
917-397-6451
Email
mzb2107@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha Scaccia, MS
Email
ses2272@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faris M Zuraikat, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marie-Pierre St-Onge, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehreen Bhatti
Phone
917-397-6451
Email
mzb2107@cumc.columbia.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Eating Behaviors in Shift Workers

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