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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 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 689-participant average among 89 other PreDiabetes trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05559515
The ClinicalTrials.gov registry entry for NCT05559515 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 214 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 689-participant average among 89 other PreDiabetes trials with a reported enrollment target (69% lower). The listed sponsor is Denver Health and Hospital Authority, which has 73 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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