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NCT00222846 · ClinicalTrials.gov registry record · NA
Enhancing Adherence in Type 2 Diabetes: The ENHANCE Study
A NA study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- NA
- Development phase
- 288
- Enrollment target
NCT00222846 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 288 participants.
The verdict
NCT00222846, a NA study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- NA
- Development phase
- 288 participants
- Enrollment target
Study Summary
This randomized study will test a behavioral intervention, based on social cognitive theory (SCT), to improve regimen adherence in three different groups of people with type 2 diabetes; (1) those with well controlled blood glucoses and no concurrent chronic renal insufficiency, (2) those with less well-controlled glucoses and no chronic renal insufficiency, and (3) those with chronic renal insufficiency regardless of glucose control. The primary aims of this study are to: (1)determine whether the intervention improves behavioral adherence to the diabetes self-management regimen including dietary adherence, physical activity, and capillary glucose self-monitoring; (2)determine whether the intervention improves clinical outcomes; (3) explore the extent to which self-efficacy is a mediator of adherence,(4) explore the extent to which the effectiveness of the intervention varies with respect to glycemic control and nephrovascular complications at baseline, and (5)explore the impact of a variety of covariates on the effectiveness of the intervention. Hypothesis #1 is that intervention group participants will perform better than attention control group participants on various measures of adherence to the diabetes management regimen. Primary adherence variables will be dietary intake, and physical activity. Hypothesis #2 is that intervention group participants will have lower HbA1c levels than attention control group participants.
Interventions
- BEHAVIORAL Intervention
- BEHAVIORAL Attention control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2004-05 |
| Est. Completion | 2009-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00222846
The ClinicalTrials.gov registry entry for NCT00222846 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Intervention is the first listed.
NCT00222846 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00222846 about?
NCT00222846 is a clinical study titled "Enhancing Adherence in Type 2 Diabetes: The ENHANCE Study". This randomized study will test a behavioral intervention, based on social cognitive theory (SCT), to improve regimen adherence in three different groups of people with type 2 diabetes; (1) those with well controlled blood glucoses and no concurrent chronic renal insufficiency, (2) those with less w...
What is the current status of trial NCT00222846?
This trial is currently completed. It is a NA study. The enrollment target is 288 participants. The study started on 2004-05. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00222846?
The interventions under investigation include: Intervention (BEHAVIORAL), Attention control (BEHAVIORAL).
Who is sponsoring clinical trial NCT00222846?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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