- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04468672
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
Status
Recruiting
Intervention / Treatment
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
- 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
- Recruiting
- Columbia University Irving Medical Center
-
Contact:
- Mehreen Bhatti
- Phone Number: 917-397-6451
- Email: mzb2107@cumc.columbia.edu
-
-
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAS8559
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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