NCT07451314

Brief Summary

This is a one-year pilot study focused on prediabetes among hospitality workers in New Orleans, Louisiana. The project will assess prediabetes rates among the target population, evaluate the impact of pharmacist led lifestyle education sessions, the provision of wellness tools, and healthcare resource referrals on participant knowledge and health behaviors. The results obtained from this study will provide enhanced understanding of prediabetes prevalence and interventions to combat health disparities within this population.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Jun 2025

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 Progress68%
Jun 2025Dec 2026

First Submitted

Initial submission to the registry

April 21, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 20, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

April 21, 2025

Last Update Submit

February 27, 2026

Conditions

Keywords

prediabetespharmacist educationdiabetes preventiondiabetes prevention programDPPhospitality workershospitalityhospitality industryhospitality workforce

Outcome Measures

Primary Outcomes (2)

  • Participant diabetes prevention knowledge as measured by survey

    Recall of key health information delivered by pharmacists and pharmacy interns as measured by pre and post scores (0%-100%) on 6 multiple choice item questionnaire.

    Immediately, 1 month post exposure and 3 months post exposure.

  • Prediabetes Risk Rate

    Rate of prediabetes risk as calculated by ADA risk calculator and A1c point of care testing

    At enrollment

Secondary Outcomes (4)

  • Prediabetes Risk Rate Concordance/Reliability

    At enrollment

  • Participants utilization of healthy lifestyle tools as measured by survey

    1 month post exposure and 3 months post exposure.

  • Participants Utilization of Linkage to Care - Diabetes Prevention Program Enrollment as measured by survey response

    1 month post exposure and 3 months post exposure.

  • Participants Utilization of Linkage to Care - Primary Healthcare Seeking as Measured by Survey Response.

    1 month post exposure and 3 months post exposure.

Study Arms (1)

Single Arm - Screening and Intervention Group

EXPERIMENTAL
Behavioral: Linkage to CareOther: EducationalOther: Healthy Lifestyle Tools

Interventions

Linkage to CareBEHAVIORAL

Resource Referral

Also known as: Prevention Program, Primary Care
Single Arm - Screening and Intervention Group

Education on risk factors, prevention methods, healthy lifestyle habits.

Also known as: Prediabetes Education
Single Arm - Screening and Intervention Group

Fitness Tracker, Healthy Portion Plate

Also known as: Health Promotion Tools
Single Arm - Screening and Intervention Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults age 18-99
  • Hospitality Worker employed within Orleans Parish

You may not qualify if:

  • Prior Diagnosis of Diabetes Type I or II
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xavier University of Louisiana - College of Pharmacy

New Orleans, Louisiana, 70125, United States

Location

MeSH Terms

Conditions

Prediabetic StateInsulin ResistanceGlucose Intolerance

Interventions

National Program of Cancer RegistriesPrimary Health Care

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismHyperglycemia

Intervention Hierarchy (Ancestors)

Centers for Disease Control and Prevention, U.S.United States Public Health ServiceUnited States Dept. of Health and Human ServicesUnited States Government AgenciesFederal GovernmentGovernmentOrganizationsHealth Care Economics and OrganizationsComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Brittany Singleton, BA, PharmD, BCPS, BCSCP

    Xavier University of Louisiana - College of Pharmacy

    PRINCIPAL INVESTIGATOR
  • Katrina Nguyen, BS, PharmD

    Xavier University of Louisiana - College of Pharmacy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Cohort
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2025

First Posted

March 5, 2026

Study Start

June 20, 2025

Primary Completion

October 3, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

March 5, 2026

Record last verified: 2026-02

Locations