Eating Behaviors in Shift Workers
The Interaction of Shift Work and Food Environment on Eating Behaviors and Appetite
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Mehreen Bhatti, BS
- Phone Number: 917-397-6451
- Email: mzb2107@cumc.columbia.edu
Study Contact Backup
- Name: Samantha Scaccia, MS
- Email: ses2272@cumc.columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Irving Medical Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
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
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Faris M Zuraikat, PhD, Columbia University
- Principal Investigator: Marie-Pierre St-Onge, PhD, Columbia University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- AAAS8559
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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