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Pre DiabeticNCT07392008

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

A study testing Paso a Paso in people with Pre Diabetic, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pre Diabetic
What is being tested?
Paso a Paso
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
1 Jul 2025to 31 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Utah

    Salt Lake City, Utah, 84132

Other trials in United States

About this study

Official title: 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.

Read the 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.
Conditions
Pre Diabetic
Being tested
Paso a Paso
Keywords
feasibility, Spanish-speaking populations, diabetes prevention adaptation
Medical subject headings
Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paso a PasoBehavioural

    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.

Study groups in NCT07392008
Study groupRoleWhat they receive
Community-based organizations leaders and community membersExperimentalPaso 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.
Receives: Behavioral: Paso a Paso

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight percent change

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

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

Secondary outcomes (1)

  1. % HbA1c

    HbA1c will be tested using Point-of-Care (POC) A1c testing, which will require a finger prick.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2026
  2. Study start1 Jul 2025
  3. Primary completion31 Mar 2026
  4. Study completion31 Mar 2026

Resources

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
Feasibility and pilot study
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07392008
Sponsor's protocol ID
IRB_00183257
Status last verified
Oct 2026
First submitted
7 Jan 2026
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) will be shared with qualified researchers upon reasonable request, following publication of the primary study results.

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 Mar;25(3):377-384. doi: 10.1007/s10995-020-03091-2. Epub 2020 Nov 28.

    PubMed 33247823

  • Ritchie ND, Sauder KA, Phimphasone-Brady P, Amura CR. Rethinking the National Diabetes Prevention Program for Low-Income Whites. Diabetes Care. 2018 Apr;41(4):e56-e57. doi: 10.2337/dc17-2230. Epub 2018 Feb 21. No abstract available.

    PubMed 29467170

  • 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. 2018 Mar;32(3):812-815. doi: 10.1177/0890117117698623. Epub 2017 Mar 20.

    PubMed 28320212

  • 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; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.

    PubMed 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 KJW, Sauder KA. Current Perspectives on the Impact of the National Diabetes Prevention Program: Building on Successes and Overcoming Challenges. Diabetes Metab Syndr Obes. 2020 Aug 19;13:2949-2957. doi: 10.2147/DMSO.S218334. eCollection 2020.

    PubMed 32903871

  • Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.

    PubMed 12453955

  • Lopez L, Golden SH. A new era in understanding diabetes disparities among U.S. Latinos--all are not equal. Diabetes Care. 2014 Aug;37(8):2081-3. doi: 10.2337/dc14-0923. No abstract available.

    PubMed 25061137

  • 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).

  • Aleman JO, Almandoz JP, Frias JP, Galindo RJ. Obesity among Latinx people in the United States: A review. Obesity (Silver Spring). 2023 Feb;31(2):329-337. doi: 10.1002/oby.23638.

    PubMed 36695058

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Paso a Paso in people with Pre Diabetic, run by University of Utah 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 0 inclusion and 4 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: finished, as of the sponsor's last update on 9 Oct 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Weight percent change (time frame: Baseline, 4-month, 12-month (exploratory)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07392008, which also lists 13 linked publications.

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 9 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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