NCT07392008

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

February 6, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

January 7, 2026

Last Update Submit

January 29, 2026

Conditions

Pre Diabetic

Keywords

feasibilitySpanish-speaking populationsdiabetes prevention adaptation

Outcome Measures

Primary Outcomes (1)

  • Weight percent change

    Will be measured in kilograms using a calibrated Tanita WB-100A scale.

    Baseline, 4-month, 12-month (exploratory)

Secondary Outcomes (1)

  • % HbA1c

    Baseline, 4-month, 12-month (exploratory)

Other Outcomes (5)

  • Waist circumference

    Baseline, 4-month, 12-month (exploratory)

  • Physical activity

    Baseline, 4-month, 12-month (exploratory)

  • Dietary intake

    Baseline, 4-month, 12-month (exploratory)

  • +2 more other outcomes

Study Arms (1)

Community-based organizations leaders and community members

EXPERIMENTAL

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

Interventions

Paso a PasoBEHAVIORAL

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.

Community-based organizations leaders and community members

Eligibility Criteria

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (13)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • Mattessich PW, Johnson KM. Collaboration: What Makes It Work: Turner Publishing Company; 2018.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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).

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • Community Research Collaborative. (2021). In it together: Community-based research guidelines for communities and higher education. Salt Lake City, UT: University of Utah.

    BACKGROUND

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Molly B Conroy, MD, MPH

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Feasibility and pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chief, Division of General Internal Medicine

Study Record Dates

First Submitted

January 7, 2026

First Posted

February 6, 2026

Study Start

July 1, 2025

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

February 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
01/2027-01/2028
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.

Locations

US(1)