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NCT05344859 · ClinicalTrials.gov registry record · NA
GODART Pilot and Feasibility
A NA study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- NA
- Development phase
- 88
- Enrollment target
NCT05344859: Completed NA study, sponsored by University of Alabama at Birmingham.
NCT05344859 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 88 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05344859, a NA study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- NA
- Development phase
- 88 participants
- Enrollment target
Study Summary
The purpose of this study is to pilot and assess the feasibility of implementing an artificial intelligence-assisted individualized lifestyle modification intervention for glycemic control in rural populations, which can be delivered even with regular landline phone service. This study will provide us with the knowledge to plan a well-powered optimization trial in the future to develop an optimal (low-cost) intervention package that can be delivered in a sustainable manner to the rural portions of America.
Primary Outcome
The inclusion criteria for a participant enrolling in the study is HbA1c ≥ 7% to ≤10.5% (for phase 1) and HbA1c ≥ 7% to ≤10.5% (phase 2). The primary outcome of the study is to track change in the HbA1C between baseline and 6 months (primary endpoint of the study). The HbA1C will be tested at baseline and 6 months. The measure of HbA1C at the end of 6 months (end of the intervention period) will be considered as the primary outcome measure to study the effectiveness of the interventions.
Interventions
- BEHAVIORAL Weekly Automated Health Coaching
- BEHAVIORAL Weekly Human Health Coaching
- BEHAVIORAL Adapted Reward Level
- BEHAVIORAL Fixed Gamified Reward Level
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2023-05-15 |
| Est. Completion | 2025-10-31 |
| Phase | NA |
What the finished NCT05344859 record still lists
NCT05344859 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 4 interventions - of which Weekly Automated Health Coaching is the first listed.
NCT05344859 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05344859 about?
NCT05344859 is a clinical study titled "GODART Pilot and Feasibility". The purpose of this study is to pilot and assess the feasibility of implementing an artificial intelligence-assisted individualized lifestyle modification intervention for glycemic control in rural populations, which can be delivered even with regular landline phone service. This study will provide ...
What is the current status of trial NCT05344859?
This trial is currently completed. It is a NA study. The enrollment target is 88 participants. The study started on 2023-05-15. Estimated completion is 2025-10-31.
What interventions are being tested in trial NCT05344859?
The interventions under investigation include: Weekly Automated Health Coaching (BEHAVIORAL), Weekly Human Health Coaching (BEHAVIORAL), Adapted Reward Level (BEHAVIORAL), Fixed Gamified Reward Level (BEHAVIORAL).
Who is sponsoring clinical trial NCT05344859?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05344859's enrollment target sits among peer trials
88 972nd of 2000 higher than 1,027 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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