Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05559515 · ClinicalTrials.gov registry record · NA
Patient-centered Goal Setting in the National Diabetes Prevention Program
A NA study of PreDiabetes, sponsored by Denver Health and Hospital Authority.
- Completed
- Registry status
- NA
- Development phase
- 214
- Enrollment target
- 1
- Study location
NCT05559515: Completed NA study of PreDiabetes, sponsored by Denver Health and Hospital Authority.
NCT05559515 is a NA study of PreDiabetes that has completed, run by Denver Health and Hospital Authority. The registered enrollment target is 214 participants, below the 700-participant average among 149 other PreDiabetes trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05559515, a NA study of PreDiabetes, has completed, sponsored by Denver Health and Hospital Authority.
- COMPLETED
- Registry status
- NA
- Development phase
- 214 participants
- Enrollment target
- 1
- Study location
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).
Primary Outcome
Glycated hemoglobin
Conditions Studied
Interventions
- BEHAVIORAL NDPP-Flex
- BEHAVIORAL NDPP
Study Locations (1)
Colorado
- Denver Health - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2023-02-01 |
| Est. Completion | 2025-10-15 |
| Phase | NA |
What the finished NCT05559515 record still lists
NCT05559515 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, below the 700-participant average among 149 other PreDiabetes trials with a reported enrollment target (69% lower).
The record links to 1 condition, with PreDiabetes appearing as the primary indexed condition, and to 2 interventions - of which NDPP-Flex is the first listed.
NCT05559515 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05559515 about?
NCT05559515 is a clinical study titled "Patient-centered Goal Setting in the National Diabetes Prevention Program". 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 ...
What is the current status of trial NCT05559515?
This trial is currently completed. It is a NA study. The enrollment target is 214 participants. The study started on 2023-02-01. Estimated completion is 2025-10-15.
What conditions does trial NCT05559515 study?
This clinical trial studies the following conditions: PreDiabetes.
What interventions are being tested in trial NCT05559515?
The interventions under investigation include: NDPP-Flex (BEHAVIORAL), NDPP (BEHAVIORAL).
Who is sponsoring clinical trial NCT05559515?
This trial is sponsored by Denver Health and Hospital Authority, which has 73 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05559515 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for PreDiabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05559515's enrollment target sits among peer trials
214 39th of 149 higher than 111 of 149 other PreDiabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PreDiabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Longitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance
RECRUITING · NA
-
Black Impact: The Mechanisms Underlying Psychosocial Stress Reduction in a Cardiovascular Health Intervention
RECRUITING · NA
-
Diabetes Clinical Decision Support
RECRUITING · NA
-
Food as Medicine for HIV and Diabetes
RECRUITING · NA
-
Cleaner Air for Lower Cardiometabolic Risk
RECRUITING · NA
-
Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04030507 · 214 participants · NA
Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
- NCT04421248 · 214 participants · Phase 4
Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder
- NCT04667520 · 214 participants · NA
Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
- NCT05418868 · 214 participants · Phase 1
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI