Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222846
Status:
COMPLETED
Last Update Posted:
2010-05-17
First Post:
2005-09-12
Brief Title:
Enhancing Adherence in Type 2 Diabetes The ENHANCE Study
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Enhancing Adherence in Type 2 Diabetics
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENHANCE
Brief 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 1determine whether the intervention improves behavioral adherence to the diabetes self-management regimen including dietary adherence physical activity and capillary glucose self-monitoring 2determine whether the intervention improves clinical outcomes 3 explore the extent to which self-efficacy is a mediator of adherence4 explore the extent to which the effectiveness of the intervention varies with respect to glycemic control and nephrovascular complications at baseline and 5explore 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
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
Detailed Description:
This randomized study the ENHANCE Study Enhancing Adherence to Diabetes Self-Management 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 HbA1c 8 and no concurrent chronic renal insufficiency 2 HbA1c8 and no chronic renal insufficiency and 3 those with evidence of 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 1a dietary adherence as measured by self-report using dietary recalls and the Nutrient Data System 1b physical activity as measured by the CHAMPS Physical Activity Questionnaire as well as pedometer readings and 1c adherence to capillary glucose self-monitoring as assessed by the FreeStyle monitor
2 Determine whether the intervention improves clinical outcome measures including 2a glycosylated hemoglobin levels HbA1c 2b weight loss 2c anthropometrics
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
5 Explore the impact of a variety of covariates medications depression social support severity of disease and general health and sociodemographic characteristics clinic from which they were recruited health literacy and trust in research 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 behavioral 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
The 6-month intervention includes group classes held weekly during months 12 biweekly during months 34 and monthly during month 56 Classes focus on building a sense of mastery over the diabetes regimen and features the use of PDA-base dietary self-monitoring Intervention group participants are compared to an attention care group that receives monthly contacts Measurements are made at baseline 3 and 6 months
The primary aims of this study are to
1 Determine whether the intervention improves behavioral adherence to the diabetes self-management regimen including 1a dietary adherence as measured by self-report using dietary recalls and the Nutrient Data System 1b physical activity as measured by the CHAMPS Physical Activity Questionnaire as well as pedometer readings and 1c adherence to capillary glucose self-monitoring as assessed by the FreeStyle monitor
2 Determine whether the intervention improves clinical outcome measures including 2a glycosylated hemoglobin levels HbA1c 2b weight loss 2c anthropometrics
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
5 Explore the impact of a variety of covariates medications depression social support severity of disease and general health and sociodemographic characteristics clinic from which they were recruited health literacy and trust in research 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 behavioral 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
The 6-month intervention includes group classes held weekly during months 12 biweekly during months 34 and monthly during month 56 Classes focus on building a sense of mastery over the diabetes regimen and features the use of PDA-base dietary self-monitoring Intervention group participants are compared to an attention care group that receives monthly contacts Measurements are made at baseline 3 and 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None