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Clinical Trials/NCT04468672
NCT04468672Active, not recruitingNot Applicable

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

Columbia University1 site in 1 country100 target enrollmentStarted: December 14, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
100
Locations
1
Primary Endpoint
Food intake

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Statistician will be blinded to participant group and condition.

Eligibility Criteria

Ages
20 Years to 55 Years (Adult)
Sex
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
  • 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

Arms & Interventions

Day worker

Active Comparator

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

Intervention: Portion size (Behavioral)

Night worker

Active Comparator

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

Intervention: Portion size (Behavioral)

Outcomes

Primary Outcomes

Food intake

Time Frame: 24-hours intake period

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

Energy intake

Time Frame: 24-hours intake period

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

Energy density consumed

Time Frame: 24-hours intake period

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

Secondary Outcomes

  • Appetite-regulating hormones(2-hours measurement period)
  • Hunger and fullness(24-hours measurement period)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marie-Pierre St-Onge

Associate Professor of Nutritional Medicine

Columbia University

Study Sites (1)

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