Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-06 @ 6:47 AM
Study NCT ID:
NCT05153759
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2021-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EMS Providers' Health Initiative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2021-11-29', 'studyFirstSubmitQcDate': '2021-11-29', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic control', 'timeFrame': 'Two weeks', 'description': 'Daily mean blood glucose'}, {'measure': 'Compliance', 'timeFrame': 'Four days', 'description': 'Percent of participants who adhere to the dietary intervention'}], 'secondaryOutcomes': [{'measure': 'Perceived stress', 'timeFrame': 'Two weeks', 'description': 'Daily rating of stress on a scale of one to 10 where 10 is the most stressed the participant has ever been'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EMS', 'Night shift', 'Nutrition', 'Insulin resistance', 'Circadian rhythm'], 'conditions': ['Shift-work Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Emergency medical service (EMS) provider\n* Works night shift only for at least one year\n* Provides patient care as primary duty\n\nExclusion Criteria:\n\n* Diagnosis of a metabolic disease (i.e. diabetes, prediabetes, metabolic syndrome)\n* Taking medication to lower blood glucose\n* Pregnant or planning to become pregnant\n* Diagnosis of kidney disease or impairment\n* Allergies or intolerances to study foods\n* Digestive disorder'}, 'identificationModule': {'nctId': 'NCT05153759', 'briefTitle': "EMS Providers' Health Initiative Study", 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': "EMS Providers' Health Initiative Study", 'orgStudyIdInfo': {'id': 'EMS Health'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High protein', 'description': 'Consuming a meal composed of 2:1 grams of protein to carbohydrate during the night shift between 7pm-7am', 'interventionNames': ['Other: Meal service']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Moderate protein', 'description': 'Consuming a meal composed of 1:1 grams of protein to carbohydrate during the night shift between 7pm-7am', 'interventionNames': ['Other: Meal service']}], 'interventions': [{'name': 'Meal service', 'type': 'OTHER', 'description': 'The primary goal is to pilot the feasibility of a meal service intervention in night shift workers', 'armGroupLabels': ['High protein', 'Moderate protein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14214', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Hostler, PhD', 'role': 'CONTACT', 'email': 'dhostler@buffalo.edu', 'phone': '716-829-6795'}, {'name': 'Tegan Mansouri, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University at Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'centralContacts': [{'name': 'Tegan H Mansouri, PhD', 'role': 'CONTACT', 'email': 'teganman@buffalo.edu', 'phone': '716-829-5596'}, {'name': 'Jocelyn Stooks, MS', 'role': 'CONTACT', 'email': 'jstooks@buffalo.edu', 'phone': '716-829-5596'}], 'overallOfficials': [{'name': 'David Hostler, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University at Buffalo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will be de-identified and kept in a password protected database (REDcap.com)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoctoral Associate', 'investigatorFullName': 'Tegan Mansouri', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}