This randomized study will test an intervention, based on social cognitive theory (SCT), to improve regimen adherence in 3 different groups of people with type 2 diabetes (n=288); (1) 96 individuals with HbA1cs<8% and no concurrent chronic renal insufficiency, (2) 96 individuals with HbA1c>8% and no chronic renal insufficiency, and (3) 96 individuals with chronic renal insufficiency regardless of glucose control. The primary aims are to: (a) determine if the intervention, compared to an attention control condition, improves behavioral adherence to the diabetes self-management regimen including: dietary adherence, as measured by dietary recalls and analyzed using the Nutrient Data System; physical activity as reported by self report using the CHAMPS Physical Activity Questionnaire and pedometer readings; adherence to capillary glucose self-monitoring as assessed by the ACCU-CHECK monitor, and adherence to medication management as determined by medication refill rates, (b) determine whether the intervention improves clinical outcome measures including: HbAlc, weight loss, and anthropometrics, (c) explore the extent to which self-efficacy is a mediator of adherence, (d) explore the extent to which the effectiveness of the intervention varies with respect to glycemic control and nephrovascular complications at baseline, and (e) explore the impact of a variety of covariates (medications, depression, social support, severity of disease, and general health and sociodemographic characteristics, and clinic from which they were recruited) 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 HbAlc levels than attention control group participants. The 6-month intervention will focus on building a sense of mastery over the following components of the regimen: glucose self-monitoring, medication self-management, diet, and physical activity. The intervention will include group classes and individual counseling. The intervention participants will be compared to an attention control group exposed to seminars and newsletters. Measurements will occur at baseline, 3 months, and 6 months. ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
5R01NR008792-04
Application #
7172288
Study Section
Nursing Research Study Section (NURS)
Program Officer
Mccloskey, Donna J
Project Start
2004-05-01
Project End
2009-01-31
Budget Start
2007-02-07
Budget End
2008-01-31
Support Year
4
Fiscal Year
2007
Total Cost
$422,083
Indirect Cost
Name
University of Pittsburgh
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Clark-Cutaia, Maya N; Ren, Dianxu; Hoffman, Leslie A et al. (2014) Adherence to hemodialysis dietary sodium recommendations: influence of patient characteristics, self-efficacy, and perceived barriers. J Ren Nutr 24:92-9
Provenzano, Laura Ferreira; Stark, Sue; Steenkiste, Ann et al. (2014) Dietary Sodium Intake in Type 2 Diabetes. Clin Diabetes 32:106-12
Sevick, Mary Ann; Korytkowski, Mary; Stone, Roslyn A et al. (2012) Biophysiologic outcomes of the Enhancing Adherence in Type 2 Diabetes (ENHANCE) trial. J Acad Nutr Diet 112:1147-57
Sevick, Mary Ann; Stone, Roslyn A; Zickmund, Susan et al. (2010) Factors associated with probability of personal digital assistant-based dietary self-monitoring in those with type 2 diabetes. J Behav Med 33:315-25
Sevick, Mary Ann; Zickmund, Susan; Korytkowski, Mary et al. (2008) Design, feasibility, and acceptability of an intervention using personal digital assistant-based self-monitoring in managing type 2 diabetes. Contemp Clin Trials 29:396-409