PrediabetesNCT07451314
Pharmacists' Delivery of Education to Prevent Diabetes in the New Orleans Hospitality Industry
A study testing Linkage to Care, Educational and Healthy Lifestyle Tools in people with Prediabetes and Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), run by Xavier University of Louisiana. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Prediabetic State &Amp; High Risk Individuals on the Basis of Diabetes Risk Score
- What is being tested?
- Linkage to Care, Educational and Healthy Lifestyle Tools
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age 18-99
- Hospitality Worker employed within Orleans Parish
Who cannot join
- Prior Diagnosis of Diabetes Type I or II
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Xavier University of Louisiana - College of Pharmacy
New Orleans, Louisiana, 70125
About this study
Official title: Pharmacists' Delivery of Health Education to Prevent Diabetes in the New Orleans Hospitality Industry Workforce
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.
- Conditions
- Prediabetes, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Prediabetic State &Amp; High Risk Individuals on the Basis of Diabetes Risk Score
- Being tested
- Linkage to Care, Educational, Healthy Lifestyle Tools
- Keywords
- prediabetes, pharmacist education, diabetes prevention, diabetes prevention program, DPP, hospitality workers, hospitality, hospitality industry, hospitality workforce
- Medical subject headings
- Prediabetic State, Insulin Resistance, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linkage to CareBehavioural
Also called Prevention Program, Primary Care
Resource Referral
EducationalOther
Also called Prediabetes Education
Education on risk factors, prevention methods, healthy lifestyle habits.
Healthy Lifestyle ToolsOther
Also called Health Promotion Tools
Fitness Tracker, Healthy Portion Plate
| Study group | Role | What they receive |
|---|---|---|
| Single Arm - Screening and Intervention Group | Experimental | Not described Receives: Behavioral: Linkage to Care; Other: Educational; Other: Healthy Lifestyle Tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: At enrollment
Secondary outcomes (4)
Prediabetes Risk Rate Concordance/Reliability
Positive concordance between results of ADA risk calculator and A1c point of care testing
Measured: At enrollment
Participants utilization of healthy lifestyle tools as measured by survey
Participants use of fitness tracker, and healthy portion plate as reported by questionnaire response on a 5 point Likert scale
Measured: 1 month post exposure and 3 months post exposure.
Participants Utilization of Linkage to Care - Diabetes Prevention Program Enrollment as measured by survey response
Participants enrollment in a diabetes prevention program as measured by participant survey response.
Measured: 1 month post exposure and 3 months post exposure.
Participants Utilization of Linkage to Care - Primary Healthcare Seeking as Measured by Survey Response.
Participants interaction with a recommended primary care facility as measured by participant survey response.
Measured: 1 month post exposure and 3 months post exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start20 Jun 2025
- Primary completion3 Oct 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xavier University of Louisiana.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brittany Singleton, BA, PharmD, BCPS, BCSCP, Principal investigator, Xavier University of Louisiana - College of PharmacyKatrina Nguyen, BS, PharmD, Principal investigator, Xavier University of Louisiana - College of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451314
- Sponsor's protocol ID
- IRB1016-25
- Status last verified
- Feb 2026
- First submitted
- 21 Apr 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacists' Delivery of Health Education to Prevent Diabetes in the New Orleans Hospitality Industry Workforce
- ClinicalTrials.gov ID
- NCT07451314
- Acronym / sponsor ID
- IRB1016-25
- Conditions
- Prediabetes, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Prediabetic State &Amp; High Risk Individuals on the Basis of Diabetes Risk Score
- Keywords
- prediabetes, pharmacist education, diabetes prevention, diabetes prevention program, DPP, hospitality workers, hospitality, hospitality industry
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xavier University of Louisiana.University, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 3 Oct 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort
| Arm | Type | Receives |
|---|---|---|
| Single Arm - Screening and Intervention Group | Experimental | Behavioral: Linkage to Care, Other: Educational, Other: Healthy Lifestyle Tools |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults age 18-99
- Hospitality Worker employed within Orleans Parish
Key exclusion criteria (2 listed)
- Prior Diagnosis of Diabetes Type I or II
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linkage to CareAlso: Prevention Program, Primary CareResource Referral | Behavioural | Single Arm - Screening and Intervention Group |
| EducationalAlso: Prediabetes EducationEducation on risk factors, prevention methods, healthy lifestyle habits. | Other | Single Arm - Screening and Intervention Group |
| Healthy Lifestyle ToolsAlso: Health Promotion ToolsFitness Tracker, Healthy Portion Plate | Other | Single Arm - Screening and Intervention Group |
Primary outcome
Participant diabetes prevention knowledge as measured by survey
Time frame: Immediately, 1 month post exposure and 3 months post exposure.
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.
Prediabetes Risk Rate
Time frame: At enrollment
Rate of prediabetes risk as calculated by ADA risk calculator and A1c point of care testing
4 secondary outcomes
Prediabetes Risk Rate Concordance/Reliability
Time frame: At enrollment
Participants utilization of healthy lifestyle tools as measured by survey
Time frame: 1 month post exposure and 3 months post exposure.
Participants Utilization of Linkage to Care - Diabetes Prevention Program Enrollment as measured by survey response
Time frame: 1 month post exposure and 3 months post exposure.
Participants Utilization of Linkage to Care - Primary Healthcare Seeking as Measured by Survey Response.
Time frame: 1 month post exposure and 3 months post exposure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brittany Singleton, BA, PharmD, BCPS, BCSCP principal investigator
Xavier University of Louisiana - College of Pharmacy
Katrina Nguyen, BS, PharmD principal investigator
Xavier University of Louisiana - College of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linkage to Care, Educational and Healthy Lifestyle Tools in people with Prediabetes and Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), run by Xavier University of Louisiana. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant diabetes prevention knowledge as measured by survey (time frame: Immediately, 1 month post exposure and 3 months post exposure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.