EMS Providers' Health Initiative Study

February 14, 2024 updated by: Tegan Mansouri, State University of New York at Buffalo
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

40

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

Study Contact Backup

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14214
        • Recruiting
        • University at Buffalo
        • Contact:
        • Principal Investigator:
          • Tegan Mansouri, PhD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High protein
Consuming a meal composed of 2:1 grams of protein to carbohydrate during the night shift between 7pm-7am
Other: Meal service
The primary goal is to pilot the feasibility of a meal service intervention in night shift workers
Placebo Comparator: Moderate protein
Consuming a meal composed of 1:1 grams of protein to carbohydrate during the night shift between 7pm-7am
Other: Meal service
The primary goal is to pilot the feasibility of a meal service intervention in night shift workers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: Two weeks
Daily mean blood glucose
Two weeks
Compliance
Time Frame: Four days
Percent of participants who adhere to the dietary intervention
Four days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived stress
Time Frame: Two weeks
Daily rating of stress on a scale of one to 10 where 10 is the most stressed the participant has ever been
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Investigators

  • Study Chair: David Hostler, PhD, University at Buffalo

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)

June 7, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

November 29, 2021

First Posted (Actual)

December 10, 2021

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EMS Health

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will be de-identified and kept in a password protected database (REDcap.com)

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.

Clinical Trials on Shift-work Disorder

Clinical Trials on Meal service

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe