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Patient-centered Goal Setting in the National Diabetes Prevention Program

NCT05559515 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2025-11-14

No results posted yet for this study

Summary

This is a cluster-randomized controlled trial of NDPP-Flex versus the standard NDPP to evaluate effects on glycemia, heterogeneity of treatment effects, and mechanisms of change. We will recruit 200 diverse adults with prediabetes (A1C 5.7-6.4%) and normal weight or overweight/obesity. Participants will enroll in classes (N=20) that are randomized to deliver NDPP-Flex or the standard NDPP. The trial is designed to have \>95% power to detect anticipated treatment effects of \~0.2% A1C improvement and \~10% increase in participants who reach normoglycemia compared to the control arm. The study will be conducted in a health system with the 6th largest network of FQHCs in the US (Denver Health) and in partnership with a premier research institution (University of Colorado).

Conditions

Interventions

BEHAVIORAL

NDPP-Flex

NDPP + patient-centered goal setting

BEHAVIORAL

NDPP

Usual care NDPP only

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • Denver Health and Hospital Authority

    lead OTHER

Principal Investigators

  • Rocio Pereira, MD · Denver Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2025-06-04
Completion
2025-10-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05559515 on ClinicalTrials.gov