EMS Providers' Health Initiative Study

Shift-work Disorder Clinical Trial

Official title:

EMS Providers' Health Initiative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05153759
• Other study ID #: EMS Health
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: State University of New York at Buffalo
• Contact: Tegan H Mansouri, PhD
• Phone: 716-829-5596
• Email: teganman[@]buffalo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to explore dietary factors that influence glycemic control in night shift EMS providers and to test the feasibility of a dietary intervention among these providers.

Description:

This study can be broken down into two phases. Both phases will take place over the course of 3 weeks. During the first week, participants will be scheduled for a single 60-90 minute zoom appointment. During this appointment, informed consent will be obtained, participants will provide health and demographic information, complete several questionnaires, and be familiarized with study protocols. The following week, participants will wear a continuous glucose monitor, actigraph activity monitor, document everything they have to eat and drink, and rate their daily stress levels. Participants will continue this during the final week and will be randomized to consume either a 2:1 or 1:1 protein to carbohydrate ratio during the night shift during this week.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Emergency medical service (EMS) provider

• Works night shift only for at least one year

• Provides patient care as primary duty

Exclusion Criteria:

• Diagnosis of a metabolic disease (i.e. diabetes, prediabetes, metabolic syndrome)

• Taking medication to lower blood glucose

• Pregnant or planning to become pregnant

• Diagnosis of kidney disease or impairment

• Allergies or intolerances to study foods

• Digestive disorder

Related Conditions & MeSH terms

• Shift-work Disorder

Intervention

Other:
• Meal service
The primary goal is to pilot the feasibility of a meal service intervention in night shift workers

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control	Daily mean blood glucose	Two weeks
Primary	Compliance	Percent of participants who adhere to the dietary intervention	Four days
Secondary	Perceived stress	Daily rating of stress on a scale of one to 10 where 10 is the most stressed the participant has ever been	Two weeks