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NCT05056376 · ClinicalTrials.gov registry record · NA
Effectiveness and Cost-Effectiveness of Fully-Automated Digital vs. Human Coach-Based Diabetes Prevention Programs
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 368
- Enrollment target
NCT05056376: Completed NA study, sponsored by Johns Hopkins University.
NCT05056376 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 368 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05056376, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 368 participants
- Enrollment target
Study Summary
The purpose of this research study is to compare the effectiveness of a fully automated digital diabetes prevention program to standard of care human coach-based diabetes prevention programs for promoting clinically meaningful lifestyle changes to reduce the risk of type 2 diabetes in adults with prediabetes.
Primary Outcome
The primary outcome was the CDC-defined diabetes risk reduction benchmark at 12 months (based on the 2021 standards), defined as at least one of the following: 1. Weight loss of ≥5%. 2. Weight loss of ≥4% combined with at least 150 weekly minutes of moderate-to-vigorous PA 3. An absolute decrease of ≥0.2 points in A1C (measured in %). The A1C endpoint was applicable only to participants with baseline A1C of 5.7% to 6.4%. Maintaining an A1C \<6.5% throughout the study was also a criterion for th
Interventions
- BEHAVIORAL Digital Diabetes Prevention Program (dDPP)
- BEHAVIORAL Human Coach-based Diabetes Prevention Program (hDPP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 368 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2024-12-16 |
| Phase | NA |
What the finished NCT05056376 record still lists
NCT05056376 is an interventional study that assigns participants to a tested intervention. The registered 368 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Digital Diabetes Prevention Program (dDPP) is the first listed.
NCT05056376 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05056376 about?
NCT05056376 is a clinical study titled "Effectiveness and Cost-Effectiveness of Fully-Automated Digital vs. Human Coach-Based Diabetes Prevention Programs". The purpose of this research study is to compare the effectiveness of a fully automated digital diabetes prevention program to standard of care human coach-based diabetes prevention programs for promoting clinically meaningful lifestyle changes to reduce the risk of type 2 diabetes in adults with pr...
What is the current status of trial NCT05056376?
This trial is currently completed. It is a NA study. The enrollment target is 368 participants. The study started on 2021-10-01. Estimated completion is 2024-12-16.
What interventions are being tested in trial NCT05056376?
The interventions under investigation include: Digital Diabetes Prevention Program (dDPP) (BEHAVIORAL), Human Coach-based Diabetes Prevention Program (hDPP) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05056376?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05056376's enrollment target sits among peer trials
368 283rd of 2000 higher than 1,717 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
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