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

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: Active, not recruiting
• Conditions: Pre Diabetic
• Intervention / Treatment: Behavioral: Paso a Paso

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: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Weight percent change	Will be measured in kilograms using a calibrated Tanita WB-100A scale.	Baseline, 4-month, 12-month (exploratory)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% HbA1c	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

Outcome Measure	Measure Description	Time Frame
Waist circumference	Will be measured in centimeters using Gulick tape and standard research protocols.	Baseline, 4-month, 12-month (exploratory)
Physical activity	Attendance in PA sessions	Baseline, 4-month, 12-month (exploratory)
Dietary intake	Mediterranean Diet Score	Baseline, 4-month, 12-month (exploratory)
Engagement measures	Retention, engagement, attendance rate (%)	Baseline, 4-month, 12-month (exploratory)
Feasibility, acceptability, and appropriateness surveys	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

• Sponsor: University of Utah
• Investigators: Principal Investigator: Molly B Conroy, MD, MPH, University of Utah

Publications and helpful links

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

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: feasibility; Spanish-speaking populations; diabetes prevention adaptation
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hyperglycemia; Nutritional and Metabolic Diseases; Glucose Intolerance
• Other Study ID 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