Enhancing Adherence in Type 2 Diabetes: The ENHANCE Study
Completed · Not applicable
Conditions studied: Diabetes Mellitus, Type 2, Diabetic Nephropathy
In brief
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.
Key facts
- Study ID
- NCT00222846
- Run by
- University of Pittsburgh
- People needed
- 288
- Starts
- 2004-05-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2010-05-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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