NCT04468672

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Dec 2020Jun 2027

First Submitted

Initial submission to the registry

June 30, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

December 14, 2020

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

6.1 years

First QC Date

June 30, 2020

Last Update Submit

February 23, 2026

Conditions

Shift Work Type Circadian Rhythm Sleep DisorderEating Behavior

Outcome Measures

Primary Outcomes (3)

  • Food intake

    Food by weight (g) in response to variations in portion served

    24-hours intake period

  • Energy intake

    Food by energy (kcal) in response to variations in portion served

    24-hours intake period

  • Energy density consumed

    Energy density consumed (kcal/g) in response to variations in portion served

    24-hours intake period

Secondary Outcomes (2)

  • Appetite-regulating hormones

    2-hours measurement period

  • Hunger and fullness

    24-hours measurement period

Study Arms (2)

Day worker

ACTIVE COMPARATOR

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

Behavioral: Portion size

Night worker

ACTIVE COMPARATOR

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

Behavioral: Portion size

Interventions

Portion sizeBEHAVIORAL

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

Day workerNight worker

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Interventions

Portion Size

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Faris M Zuraikat, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Marie-Pierre St-Onge, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Statistician will be blinded to participant group and condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Nutritional Medicine

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 13, 2020

Study Start

December 14, 2020

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After the study is completed (data collection, analysis, publication) and after any subsequent funding applications have been submitted.
Access Criteria
Upon request

Locations

US(1)