Eating Behaviors in Shift Workers

Sponsor

Columbia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04468672

Collaborator

(none)

100

Enrollment

Location

Arms

23.6

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Shift Work Type Circadian Rhythm Sleep Disorder Eating Behavior	Behavioral: Portion size	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention 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)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:

Single (Outcomes Assessor)

Masking Description:

Statistician will be blinded to participant group and condition.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 14, 2020

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Day worker

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

Behavioral: Portion size

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

Behavioral: Portion size

The amount of food served (g) at the first two meals of each day. These amounts will vary across 4 weeks.

Outcome Measures

Primary Outcome Measures

Food intake [24-hours intake period]
Food by weight (g) in response to variations in portion served
Energy intake [24-hours intake period]
Food by energy (kcal) in response to variations in portion served
Energy density consumed [24-hours intake period]
Energy density consumed (kcal/g) in response to variations in portion served

Secondary Outcome Measures

Appetite-regulating hormones [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
Hunger and fullness [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Irving Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

Columbia University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marie-Pierre St-Onge, Associate Professor of Nutritional Medicine, Columbia University

ClinicalTrials.gov Identifier:

NCT04468672

Other Study ID Numbers:

AAAS8559

First Posted:

Jul 13, 2020

Last Update Posted:

Feb 11, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sleep Wake Disorders

Sleep Disorders, Circadian Rhythm

Study Results

No Results Posted as of Feb 11, 2022