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Active, Not Recruiting

NCT Number: NCT07392008

PASO A PASO: 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pre Diabetic Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84132, United States

About this study

Specific goals include:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Paso a Paso

Behavioral

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.

Primary outcomes

  1. Weight percent change

    Time frame: Baseline, 4-month, 12-month (exploratory)

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

Secondary outcomes

  1. % 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.

Other outcomes

  1. Waist circumference

    Time frame: Baseline, 4-month, 12-month (exploratory)

    Will be measured in centimeters using Gulick tape and standard research protocols.

  2. Physical activity

    Time frame: Baseline, 4-month, 12-month (exploratory)

    Attendance in PA sessions

  3. Dietary intake

    Time frame: Baseline, 4-month, 12-month (exploratory)

    Mediterranean Diet Score

  4. Engagement measures

    Time frame: Baseline, 4-month, 12-month (exploratory)

    Retention, engagement, attendance rate (%)

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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