PASO A PASO: Tailored Diabetes Prevention Program for Spanish-Speaking Communities Feasibility Study

January 29, 2026 updated by: Margaret (Molly) B. Conroy, University of Utah

PASO A PASO Pilot Study: Tailored Diabetes Prevention Program for Spanish-Speaking Communities Feasibility Study

The interdisciplinary and interprofessional community-academic partnership (CAP) has been working with Spanish-speaking H/L Salt Lake City residents and organization leaders to adapt the National Diabetes Prevention Program to meet the needs of this population. This next collaboration phase attempts to finalize the adapted diabetes prevention program, "Paso a Paso," and evaluate its feasibility and implementation strategies. The purpose of this pilot study is to inform the necessary modifications to the Paso a Paso diabetes prevention intervention, ensuring that the full-scale future intervention is both feasible and effective for the target community.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Specific goals include:

  1. Finalize the adapted "Paso a Paso" protocol and materials.
  2. Train the first cohort of instructors for the program (10-15 potential instructors)
  3. Test the feasibility of the intervention implementation with 30 community participants.
  4. Gather feedback from participants, refine the intervention, and ensure that it resonates with community members, ultimately laying the foundation for a successful larger study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: Native Spanish speakers, residents in the Wasatch Front Metropolitan area, adults aged >18 years old with a BMI of ≥ 25, and diabetes risk >1 based on the CDC Prediabetes Risk Test

Exclusion Criteria:

  1. Bariatric surgery in the last 2 years or planned during the next year
  2. Edematous state that interferes with body weight assessment (e.g., severe congestive heart failure, end-stage renal disease, or ascites)
  3. Current or planned pregnancy in the next year
  4. Current breastfeeding

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Community-based organizations leaders and community members
Paso a Paso is a 12-month program designed for H/L community members who are at high risk for T2D and want to lower their risk.
Behavioral: Paso a Paso
Cultural components will include fostering a sense of belonging, collaboration, support, interaction, and respect. Program structure: Paso a Paso is designed to include weekly 90-minute in-person sessions over the first 4 months of the program, which will transition to monthly sessions over the final 8 months of the intervention. All sessions will include hands-on skill development, group and social activities, and addressing assets for diabetes prevention available in the community. Finally, the intervention also includes an online community forum to support ongoing social support and information provision.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight percent change
Time Frame: Baseline, 4-month, 12-month (exploratory)
Will be measured in kilograms using a calibrated Tanita WB-100A scale.
Baseline, 4-month, 12-month (exploratory)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
% HbA1c
Time Frame: Baseline, 4-month, 12-month (exploratory)
HbA1c will be tested using Point-of-Care (POC) A1c testing, which will require a finger prick.
Baseline, 4-month, 12-month (exploratory)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Waist circumference
Time Frame: Baseline, 4-month, 12-month (exploratory)
Will be measured in centimeters using Gulick tape and standard research protocols.
Baseline, 4-month, 12-month (exploratory)
Physical activity
Time Frame: Baseline, 4-month, 12-month (exploratory)
Attendance in PA sessions
Baseline, 4-month, 12-month (exploratory)
Dietary intake
Time Frame: Baseline, 4-month, 12-month (exploratory)
Mediterranean Diet Score
Baseline, 4-month, 12-month (exploratory)
Engagement measures
Time Frame: Baseline, 4-month, 12-month (exploratory)
Retention, engagement, attendance rate (%)
Baseline, 4-month, 12-month (exploratory)
Feasibility, acceptability, and appropriateness surveys
Time Frame: Baseline, 4-month, 12-month (exploratory)
Validated a 5-point Likert scale to evaluate if an intervention is appealing, fits the context, and can be implemented.
Baseline, 4-month, 12-month (exploratory)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Utah

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Molly B Conroy, MD, MPH, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Wells R, Yates L, Morgan I, deRosset L, Cilenti D. Using the Wilder Collaboration Factors Inventory to Strengthen Collaborations for Improving Maternal and Child Health. Matern Child Health J. 2021;25(3):377-84. Epub 2020/11/29. doi: 10.1007/s10995-020-03091-2. PubMed PMID: 33247823; PMCID: PMC7956933.
  • Ritchie ND, Sauder KA, Phimphasone-Brady P, Amura CR. Rethinking the National Diabetes Prevention Program for low-income whites. Diabetes care. 2018;41(4):e56-e7. doi: 10.2337/dc17-2230.
  • Mattessich PW, Johnson KM. Collaboration: What Makes It Work: Turner Publishing Company; 2018.
  • Ritchie ND, Christoe-Frazier L, McFann KK, Havranek EP, Pereira RI. Effect of the National Diabetes Prevention Program on weight loss for English- and Spanish-speaking Latinos. Am J Health Promot. 2017;32(3):812-5. doi: 10.1177/0890117117698623.
  • Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. The New England journal of medicine. 2001;344(18):1343-50. Epub 2001/05/03. doi: 10.1056/nejm200105033441801. PubMed PMID: 11333990.
  • The National Registry of Recognized Diabetes Prevention Programs 2024: Centers for Disease Control and Prevention; [cited 2024 March 24]. Available from: https://dprp.cdc.gov/Registry.
  • Ritchie ND, Baucom KJ, Sauder KA. Current perspectives on the impact of the National Diabetes Prevention Program: building on successes and overcoming challenges. Diabetes Metab Syndr Obes. 2020;13:2949-57. doi: 10.2147/dmso.s218334.
  • Diabetes Prevention Program Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes care. 2002;25(12):2165-71. doi: 10.2337/diacare.25.12.2165. PubMed PMID: 12453955; PMCID: PMC1282458.
  • López L, Golden SH. A new era in understanding diabetes disparities among U.S. Latinos-all are not equal. Diabetes care. 2014;37(8):2081-3. doi: 10.2337/dc14-0923.
  • National diabetes statistics report: Centers for Disease Control and Prevention; 2024 [updated May 5, 2024; cited 2024 June 30]. Available from: https://www.cdc.gov/diabetes/php/data-research/index.html#:~:text=Among%20the%20U.S.%20population%20overall,Table%201a%3B%20Table%201b).
  • Alemán JO, Almandoz JP, Frias JP, Galindo RJ. Obesity among Latinx people in the United States: A review. Obesity. 2023;31(2):329-37. doi: 10.1002/oby.23638.
  • Vespa J, Medina L, Armstrong D. Demographic turning points for the United States: population projections for 2020 to 2060: US Census Bureau; 2020 [updated February 2020; cited 2024 July 27]. Available from: https://www.census.gov/content/dam/Census/library/publications/2020/demo/p25-1144.pdf.
  • Community Research Collaborative. (2021). In it together: Community-based research guidelines for communities and higher education. Salt Lake City, UT: University of Utah.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB_00183257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) will be shared with qualified researchers upon reasonable request, following publication of the primary study results.

IPD Sharing Time Frame

01/2027-01/2028

IPD Sharing Access Criteria

Access will be limited to investigators with demonstrated scientific merit and the capacity to securely manage human subjects data. Shared data will exclude direct identifiers and comply with IRB approvals and HIPAA requirements for data-sharing expectations.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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.

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