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NCT00473811 · ClinicalTrials.gov registry record · Phase 1
Diabetic Educational Eating Plan
A Phase 1 study, sponsored by University of Massachusetts, Worcester.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00473811: Completed Phase 1 study, sponsored by University of Massachusetts, Worcester.
NCT00473811 is a Phase 1 study that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00473811, a Phase 1 study, has completed, sponsored by University of Massachusetts, Worcester.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
By improving glycemic control, many of the devastating complications of diabetes are to a large extent preventable. The use of a low GI (glycemic index) diet to improve glycemic control is relatively new and untested. However, a low GI diet may be a cost-effective approach to preventing diabetes-related complications. The aim of this proposed 2-year study is to gather pilot data on the feasibility of implementing a nutritionist-delivered low GI intervention, to reduce dietary GI in patients with type 2 diabetes, and to compare it with a nutritionist-delivered standard American Diabetes Association (ADA) diet intervention. Our outcomes are recruitment and retention rates, as well as physiological measures (HbA1c, blood lipids, blood pressure, and body mass index), dietary GI scores and acceptability of the intervention. Primary hypotheses: 1\. Recruitment and retention rates for the low GI intervention will be satisfactory. Secondary hypotheses: 1. Participants in the low GI intervention group will show more favorable changes in physiological measures than participants in the ADA diet group. 2. Participants in the low GI group will be successful in lowering the GI of their diet. 3. Participants will find the intervention acceptable.
Interventions
- BEHAVIORAL Low GI
- BEHAVIORAL ADA diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2005-08 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
What the finished NCT00473811 record still lists
NCT00473811 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Low GI is the first listed.
NCT00473811 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00473811 about?
NCT00473811 is a clinical study titled "Diabetic Educational Eating Plan". By improving glycemic control, many of the devastating complications of diabetes are to a large extent preventable. The use of a low GI (glycemic index) diet to improve glycemic control is relatively new and untested. However, a low GI diet may be a cost-effective approach to preventing diabetes-rel...
What is the current status of trial NCT00473811?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2005-08. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00473811?
The interventions under investigation include: Low GI (BEHAVIORAL), ADA diet (BEHAVIORAL).
Who is sponsoring clinical trial NCT00473811?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00473811's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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