Diabetes Mellitus, Type 2, Diabetic Nephropathy
Conditions
Keywords
Clinical trial, Behavioral research, Patient compliance
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: (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.
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) HbA1c\>8% 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: 1.a. dietary adherence, as measured by self-report using dietary recalls and the Nutrient Data System, 1.b. physical activity as measured by the CHAMPS Physical Activity Questionnaire as well as pedometer readings, and 1.c. adherence to capillary glucose self-monitoring as assessed by the FreeStyle monitor. 2. . Determine whether the intervention improves clinical outcome measures including: 2.a. glycosylated hemoglobin levels (HbA1c), 2.b. weight loss, 2.c. 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 1&2, biweekly during months 3&4, and monthly during month 5&6. 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.
Interventions
BEHAVIORALAttention control
Participants attend 3 educational seminars, receive a lay diabetes journal, pedometer, and glucose monitoring supplies.
BEHAVIORALIntervention
Behavioral intervention of diabetes self-management paired with PDA-based monitoring of dietary intake and physical activity. Participants also receive a pedometer and glucose self-monitoring supplies.
Sponsors
National Institute of Nursing Research (NINR)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Study subjects will include those with: type 2 diabetes mellitus defined according to the 1997 ADA criteria and age of 18 years or greater. We will sample from three different patient populations: (1) 96 individuals who have HbA1c \< 8%, and no evidence of chronic renal insufficiency (a serum creatinine \<1.3mg/dl for women and \<1.5mg/dl for men). (2) 96 individuals with HbA1c \> 8%, and no evidence of chronic renal insufficiency, and (3) 96 individuals with evidence of chronic renal insufficiency (a serum creatinine \>1.3mg/dl for women and \>1.5mg/dl for men, but who have not yet progressed to dialysis), regardless of HbA1c level. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical activity CHAMPS | Baseline, 3 and 6 months |
| Glycemic control - HbA1c | Baseline, 3 and 6 months |
| Dietary adherence | Baseline, 3 and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Adherence to capillary glucose checks - glucometer uploads | Baseline, 3 and 6 months |
| Waist circumference | Baseline, 3 and 6 months |
| Weight loss | Baseline, 3 and 6 months |
| BMI | Baseline, 3 and 6 months |
Countries
United States
Outcome results
None listed